Publications by authors named "Elizabeth G Raymond"

67 Publications

Clinical and service delivery implications of omitting ultrasound before medication abortion provided via direct-to-patient telemedicine and mail.

Contraception 2021 Jul 28. Epub 2021 Jul 28.

Gynuity Health Projects, New York, NY, United States.

Objectives: To compare outcomes among patients who did or did not have pre-abortion ultrasound or pelvic exam before obtaining medication abortion (MA) via direct-to-patient telemedicine and mail.

Study Design: We analyzed data from participants screened for enrollment into the TelAbortion study at five sites from March 25 to September 15, 2020. We compared participants who had preabortion ultrasound or pelvic exam ("test-MA") to those who did not ("no-test MA"). Outcomes were: abortion not complete with pills alone (i.e., had procedure intervention or ongoing pregnancy), ongoing pregnancy separately, ectopic pregnancy, hospitalization and/or blood transfusion, and unplanned clinical encounters. We used propensity score weighting and multivariable logistic regression to adjust for baseline characteristics.

Results: Our analysis included 287 participants who had no-test MA and 125 who had test-MA. Abortion was not complete with pills alone in 16of 287 (5.6%) no-test MA patients compared to 2of 123 (1.9%) test-MA patients (adjusted risk difference [aRD] = 4.3%, 95% confidence interval [CI]: 1.4%-7.1%). No ectopic pregnancies were detected. Groups did not differ regarding hospitalization and/or blood transfusion (p = 0.76) or ongoing pregnancy diagnosis (p = 0.59). Unplanned clinical encounters were more common in no-test MA patients (35of 287, 12.5%) than test-MA patients (10of 125, 8.0%, aRD = 6.7%, 95% CI: 0.5%-13.1%).

Conclusions: Compared to patients who had pre-abortion ultrasound, patients who had no-test MA via telemedicine were more likely to have abortions that were not complete with pills alone and/or unplanned clinical encounters. However, both no-test and test-MA patients had similar and very low rates of ongoing pregnancy and hospitalization or blood transfusion.

Implications: Omitting pre-abortion ultrasound before provision of medication abortion via telemedicine does not appear to compromise safety or result in more ongoing pregnancies. However, compared to patients who have preabortion ultrasound, patients who do not have pre-abortion tests may be more likely to seek post-treatment care and have procedural interventions.
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http://dx.doi.org/10.1016/j.contraception.2021.07.108DOI Listing
July 2021

Analytical Comparison of Pregnancy-Associated Plasma Protein-A (PAPP-A) Immunoassays for Biochemical Determination of Gestational Age.

J Appl Lab Med 2021 Jul 30. Epub 2021 Jul 30.

Gynuity Health Projects, New York, NY 10017.

Background: Accurate pregnancy dating is critical for maternal and child health and for counseling on safe and effective abortion methods. While last menstrual period and first trimester ultrasound are often used together to determine gestational age (GA), they have limited accuracy and availability, respectively. Prior studies have shown that pregnancy-associated plasma protein-A (PAPP-A) increases exponentially during pregnancy and has the potential to serve as a biochemical marker of GA. We aimed to analyze the relationship between sonographically determined GA and serum PAPP-A concentration measured by different immunoassays and to derive cutoff levels informative for the 70 days GA commonly recommended limit for medical abortion in outpatient settings.

Methods: We compared technical characteristics of 4 commercially available PAPP-A immunoassays and tested 120 maternal serum samples (GA range: 34-231 days) along with contrived pool samples and traceable quality controls. These characteristics included area under the receiver operator characteristic (AUROC) plot, sensitivity and specificity based on cutoffs defined by the Youden Index, and likelihood ratios.

Results: All 4 immunoassays had sensitivities and specificities ≥80%, and AUROC values ranging from 0.948 to 0.968. Marked differences among absolute PAPP-A values were noted depending on immunoassay. PAPP-A cutoff values at 70 days GA for each individual immunoassay were established along with procedural recommendations that increase equivalence among immunoassays.

Conclusions: Maternal serum PAPP-A levels correlated strongly with GA despite differences in immunoassay formats and absolute data output. Serum PAPP-A has biomarker potential for future development of a point-of-care test aimed at increasing access to medical abortion.
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http://dx.doi.org/10.1093/jalm/jfab057DOI Listing
July 2021

"False positive" urine pregnancy test results after successful medication abortion.

Contraception 2021 Jun 14;103(6):400-403. Epub 2021 Feb 14.

Gynuity Health Projects, New York, NY, USA.

Objective: To examine the proportion of high-sensitivity urine pregnancy test (HSPT) results that were positive by time after successful medication abortion.

Study Design: We used data from an ongoing study that provides mifepristone and misoprostol for medication abortion by direct-to-patient telemedicine and mail. Providers evaluated abortion outcomes by patient interview and clinical tests per clinical judgment and participant preference. We identified all participants enrolled July 2016 to September, 2020 who had an HSPT result and no indication of viable pregnancy after treatment. We used logistic regression to examine the association between the timing of the initial post-treatment HSPT, gestational age, and the proportion of HSPTs that gave a positive result.

Results: Of the 472 participants in our analysis, 88 (19%) had positive initial HSPTs. The proportions that were positive at ≤20 days, 21 to 27 days, 28 to 34 days, and ≥35 days after mifepristone ingestion was 14 of 29 (48%), 15 of 58 (26%), 49 of 258 (19%), and 10 of 127 (8%), respectively (p < 0.001). Gestational age at mifepristone ingestion was not significantly related to positive HSPT results (p = 0.28). Multivariable logistic regression confirmed both findings and did not identify a statistically significant interaction between these variables. In the 67 participants who relied solely on further HSPTs to confirm abortion outcome, the median interval between the initial positive test and first negative test was 14 days.

Conclusions: The proportion of participants with positive HSPTs declined with time after successful medication abortion. However, nearly one-fifth of participants with complete abortion had positive tests 4 weeks after treatment.

Implications: HSPTs provide an inexpensive, convenient option for confirming success of medication abortion at home. However, a substantial minority of patients without ongoing pregnancy have positive HSPT results. Development of a symptom-based strategy for medication abortion outcome assessment without any confirmatory tests should be a priority.
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http://dx.doi.org/10.1016/j.contraception.2021.02.004DOI Listing
June 2021

Sensitivity and specificity of placental proteins for gestational age screening: An exploratory study.

Contraception 2020 05 1;101(5):309-314. Epub 2020 Feb 1.

University of Pennsylvania Medical Center, Division of Reproductive Endocrinology and Infertility, 3701 Market Street, Suite 800, Philadelphia, PA 19104, United States. Electronic address:

Objective: To examine the possibility that serum or urine concentrations of pregnancy-associated plasma protein A (PAPP-A), a disintegrin and metalloproteinase 12 (ADAM-12), placental growth factor (PlGF), human placental lactogen (HPL), glypican-3, pregnancy specific beta-1-glycoprotein 1 (PSG-1) or prolactin could predict gestational age (GA) >70 days, the currently recommended limit for medical abortion in the United States.

Study Design: In this exploratory observational study, we collected serum and urine specimens from 245 healthy individuals with singleton intrauterine pregnancies at GA <40 weeks by ultrasound. We assayed the serum specimens for all seven proteins and the urine specimens for PAPP-A and ADAM-12. We used scatterplots and receiver operating characteristic curves to identify a concentration for each protein that would differentiate GAs above and below 70 days.

Results: All seven proteins showed significant ability to distinguish GAs >70 days from earlier gestations. A PAPP-A concentration ≥5.591 ng/ml provided 100% sensitivity and 90% specificity for identifying GAs >70 days. An ADAM-12 concentration of ≥3.11 ng/ml provided 98.5% sensitivity and 77% specificity for identifying GAs >70 days. Serum concentrations of the other compounds showed less diagnostic discrimination. PAPP-A was not detected in urine, and urinary ADAM-12 concentrations were not useful in identifying GAs above 70 days.

Conclusion: PAPP-A and ADAM-12 showed considerable promise as bases for a sensitive and specific serum test for identifying pregnancies with GA >70 days. If these results are confirmed by future research, such a test could obviate the need for routine ultrasound before medical abortion.

Implications: Two placental proteins, PAPP-A and ADAM-12, showed considerable promise as bases for a serum test for identifying pregnancies with gestational age >70 days. Such a test could be highly useful in screening patients for eligibility for medical abortion.
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http://dx.doi.org/10.1016/j.contraception.2020.01.007DOI Listing
May 2020

Efficacy of Misoprostol Alone for First-Trimester Medical Abortion: A Systematic Review.

Obstet Gynecol 2019 01;133(1):137-147

Gynuity Health Projects, New York, New York; the University of Colorado Hospital Anschutz Medical Campus, Aurora, Colorado; and the Department of Mathematics and Statistics, Elon University, Elon, North Carolina.

Objective: To summarize available data on the effectiveness and safety of single-agent misoprostol for medical abortion in the first trimester.

Data Sources: We searched MEDLINE, CABI, Cochrane, EMBASE, LILACS, the Web of Science, and ClinicalTrials.gov for English-language studies that evaluated misoprostol alone for abortion of a viable pregnancy in the first trimester.

Methods Of Study Selection: Our search yielded 1,562 citations, of which 38 included data from 53 trial groups that met our inclusion and exclusion criteria.

Tabulation, Integration, And Results: We abstracted data about each trial group, including study characteristics, treatment regimen, clinical protocol, number of women treated and followed, and numbers with outcomes of interest. We used meta-analytic methods and logistic regression to examine factors associated with surgical intervention after treatment. Among all 12,829 evaluable women, 2,536 (meta-analytic estimate 22.0%, 95% CI 18.8-25.5%) had surgical uterine evacuation. Multiple factors were significantly associated with this proportion, including misoprostol amount per dose and route of administration, loss to follow-up rate, publication date, geographic region, number of misoprostol doses, duration of dosing, and time between dosing and evaluation. Of 6,359 evaluable women, 384 (meta-analytic estimate 6.8%, 95% CI 5.3-8.5%) had ongoing pregnancies. At most 26 of 12,184 evaluable women (meta-analytic estimate 0.7%, 95% CI 0.4-1.0%) were transfused or hospitalized for abortion-related reasons. In trials that provided satisfaction data, most women were satisfied or very satisfied with the treatment (meta-analytic estimate 78%, 95% CI 71-85%).

Conclusions: Misoprostol alone is effective and safe and is a reasonable option for women seeking abortion in the first trimester. Research is indicated to further refine the regimen and to establish efficacy in the late first trimester.

Systematic Review Registration: PROSPERO, CRD42018083589.
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http://dx.doi.org/10.1097/AOG.0000000000003017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6309472PMC
January 2019

A direct-to-patient telemedicine abortion service in Australia: Retrospective analysis of the first 18 months.

Aust N Z J Obstet Gynaecol 2018 Jun 30;58(3):335-340. Epub 2018 Mar 30.

Gynuity Health Projects, New York, NY, USA.

Background: In 2015, the Tabbot Foundation launched a nationwide direct-to-patient telemedicine service to enable women to obtain medical abortion without visiting an abortion provider.

Aims: We aimed to describe results from the first 18 months of this service.

Materials And Methods: To have an abortion through the Foundation, a woman obtained screening tests locally and had a telephone consultation with a Foundation doctor. If she was eligible, mifepristone, misoprostol and other medications were sent to her by mail. After taking the drugs, the woman obtained follow-up tests at local facilities and had a consultation with Foundation professionals. The Foundation charged $250 to patients with Medicare eligibility and $600 otherwise. We summarised clinical data collected by the service.

Results: Between June 2015 and December 2016, 1010 women received medications, of whom 56% lived outside of major cities. Ninety-five percent of packages were sent within 15 days after registration. Of the 965 women who took misoprostol, outcomes were definitively documented for 754 (78%), of whom 96% had a complete abortion without surgical intervention, and 95% had no face-to-face clinical encounter after treatment. Of women with Medicare cards, 72% paid no out-of-pocket charges other than to the Foundation. Nearly all women (781/802; 97%) were highly satisfied.

Conclusions: The direct-to-patient telemedicine medical abortion service was effective, safe, inexpensive and satisfactory. It disproportionately served women in parts of Australia with limited access to abortion facilities. This experience may be instructive for others desiring to use telemedicine to enhance access to abortion.
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http://dx.doi.org/10.1111/ajo.12800DOI Listing
June 2018

Low-sensitivity urine pregnancy testing to assess medical abortion outcome: A systematic review.

Contraception 2018 07 10;98(1):30-35. Epub 2018 Mar 10.

Gynuity Health Projects, 15 E 26th Street, Suite 801, New York, NY, 10010, USA.

Objective: The objective was to summarize data on the accuracy and acceptability of a strategy for identifying ongoing pregnancy after medical abortion treatment using a low-sensitivity pregnancy test (LSPT).

Study Design: We searched PubMed to identify studies that evaluated the use of a single posttreatment LSPT for detection of ongoing pregnancy after treatment with mifepristone and misoprostol. We extracted, assessed and summarized data from each study.

Results: We found 10 studies that evaluated 6 LSPTs with human chorionic gonadotropin detection thresholds of 1000, 1500 or 2000 mIU/mL. The three earliest studies compared the pregnancy test strategy to standard assessment in the same women; the sensitivity of a positive or invalid LSPT result for detecting ongoing pregnancy ranged from 67% to 100%. Three randomized trials found no significant difference in detection of ongoing pregnancy between the LSPT strategy and routine in-person follow-up. Four noncomparative studies found that of the 12 women who had ongoing pregnancies diagnosed after performing an LSPT, 8 (67%) had positive or invalid LSPT results. Across the 10 studies, 30 of the 59 total ongoing pregnancies (51%) were identified based on symptoms without a positive or invalid LSPT result. Women expressed satisfaction with the LSPT strategy. Risk of bias in the seven later studies was high.

Conclusions: Despite their limitations, most studies showed that the LSPT strategy had moderate sensitivity for identifying ongoing pregnancy and can enable the majority of medical abortion patients to assess treatment outcome at home. However, the LSPT itself had a limited role in the detection of treatment failures in the studies.

Implications Statement: The LSPT strategy shows promise for reducing the need for in-person follow-up after medical abortion. A range of home-based options should be validated to meet the varied needs of women and abortion providers in diverse settings.
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http://dx.doi.org/10.1016/j.contraception.2018.03.013DOI Listing
July 2018

Self-assessment of medical abortion outcome using symptoms and home pregnancy testing.

Contraception 2018 04 11;97(4):324-328. Epub 2017 Dec 11.

University of North Carolina at Chapel Hill, Departments of Medicine and Biostatistics, Chapel Hill, NC, USA.

Objectives: We aimed to evaluate compliance with a strategy to enable medical abortion patients to assess treatment outcome on their own and decide whether to seek clinical follow-up.

Study Design: We enrolled women undergoing medical abortion with mifepristone and misoprostol at three clinics in the United States. Each participant was instructed to perform a multilevel pregnancy test (MLPT) 7 days after mifepristone ingestion and to contact the clinic immediately if the test indicated a possible ongoing pregnancy or if specified symptoms occurred. A telephone call was scheduled 14 days after mifepristone ingestion to evaluate participants who had not contacted the clinic earlier.

Results: Of the 343 enrolled participants, 90 (26%) did not provide sufficient follow-up information for analysis of compliance with instructions. Of the 253 (74%) who did, 218 (86%) implemented the self-assessment strategy as instructed, 20 (7.9%) failed to report a non-reassuring MLPT result, 4 (1.6%) failed to promptly report symptoms that the study clinician subsequently judged to require evaluation, and 11 (4.3%) did not perform the MLPT. We ascertained abortion outcomes for 239 (70%) of the enrolled women, of whom three were diagnosed with ongoing pregnancies. One other participant was hospitalized for bleeding. All four women had implemented the strategy correctly. Of the 219 enrolled participants (64%) who provided opinions, 170 (78%) indicated that most could use the MLPT to decide whether they are "OK" after an abortion. We did not ascertain opinions from 124 enrolled participants (36%).

Conclusions: At least two thirds of enrolled participants correctly implemented a strategy using symptom evaluation and a MLPT to assess their own medical abortion outcomes. No ongoing pregnancies occurred in women documented not to have implemented the strategy as intended. Perceived feasibility of the self-assessment approach was high. Implications Statement The common practice of scheduling a clinical contact after every medical abortion may not be necessary to ensure safety; enabling patients to determine for themselves whether or not a contact is needed can be a reasonable approach.
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http://dx.doi.org/10.1016/j.contraception.2017.12.004DOI Listing
April 2018

Simplified medical abortion screening: a demonstration project.

Contraception 2018 04 21;97(4):292-296. Epub 2017 Nov 21.

Gynuity Health Projects, New York, NY 10010, USA.

Objectives: The objectives were to evaluate the safety and acceptability of outpatient medical abortion in selected women without a pretreatment ultrasound or pelvic examination.

Study Design: We conducted a prospective case-series study to estimate the incidence of serious adverse events (death, life-threatening event, hospitalization, transfusion or any other medical problem that we judged to be significant), surgical completion of the abortion and satisfaction in women provided with medical abortion without a pretreatment ultrasound or pelvic examination. We enrolled 406 women requesting medical abortion in Moldova, Mexico and the United States. To be eligible, a woman must have been certain that her last menstrual period started within the prior 56days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2months (in the United States and Mexico) or 3months (in Moldova), have no risk factors for or symptoms of ectopic pregnancy, and not have had an ultrasound or pelvic exam in this pregnancy. One site also excluded women with uterine enlargement on abdominal palpation. Each participant received mifepristone (200mg orally) and misoprostol (400 mcg sublingually in Moldova; 800 mcg buccally at all other sites) and was followed until complete abortion, defined as requiring no further treatment.

Results: Of the 365 (90%) participants who provided sufficient follow-up information for analysis, 347 (95%) had complete abortion without additional treatment, 5 (1%) had surgical aspiration, and 10 (3%) had extra misoprostol. Three participants (1%) had serious adverse events; these included two hospital admissions for heavy bleeding managed with aspiration and one diagnosis of persistent gestational sac 19days after enrollment. Most (317, 90%) participants were pleased with omitting the pretreatment ultrasound and pelvic exam.

Conclusions: In this study, medical abortion without screening ultrasound or pelvic exam resulted in no serious adverse events that were likely to have been prevented by those tests and was highly acceptable.

Implications: Screening for medical abortion without exam or ultrasound shows promise as a means for increasing access to this service. More research is needed to develop screening criteria that are more inclusive and simpler for clinical use.
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http://dx.doi.org/10.1016/j.contraception.2017.11.005DOI Listing
April 2018

Exploring the feasibility of obtaining mifepristone and misoprostol from the internet.

Contraception 2018 04 11;97(4):287-291. Epub 2017 Oct 11.

Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA.

Objectives: We aimed to document the experience of buying abortion pills from online vendors that do not require a prescription and to evaluate the active ingredient content of the pills received.

Study Design: We searched the internet to identify a convenience sample of websites that sold mifepristone and misoprostol to purchasers in the United States and attempted to order these products. We documented price, shipping time and other aspects of ordering. We sent the samples received to a testing laboratory that measured the amount of active ingredient in individual tablets.

Results: We identified 18 websites and ordered 22 products: 20 mifepristone-misoprostol combination products and 2 that contained only misoprostol. We received 18 combination products and the 2 misoprostol products from 16 different sites. No site required a prescription or any relevant medical information. The time between order and receipt of the 20 products ranged from 3 to 21 business days (median 9.5 days). The price for the 18 combination products ranged from $110 to $360, including shipping and fees; the products without mifepristone cost less. Chemical assays found that the 18 tablets labeled 200 mg mifepristone contained between 184.3 mg and 204.1 mg mifepristone, while the 20 tablets labeled 200 mcg misoprostol contained between 34.1 mcg and 201.4 mcg of the active ingredient.

Conclusions: Obtaining abortion medications from online pharmaceutical websites is feasible in the United States. The mifepristone tablets received contained within 8% of the labeled amount of active agent. The misoprostol tablets all contained that compound but usually less than labeled.

Implications Statement: Given our findings, we expect that some people for whom clinic-based abortion is not easily available or acceptable may consider self-sourcing pills from the internet to be a rational option.
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http://dx.doi.org/10.1016/j.contraception.2017.09.016DOI Listing
April 2018

Serial multilevel urine pregnancy testing to assess medical abortion outcome: a meta-analysis.

Contraception 2017 May 29;95(5):442-448. Epub 2016 Dec 29.

Gynuity Health Projects, 15 E 26th Street, Suite 801, New York, NY, 10010, USA.

Objectives: To summarize data on the accuracy of a strategy designed to exclude ongoing pregnancy after medical abortion treatment by observing a decline in urine human chorionic gonadotropin (hCG) concentration as estimated by multilevel urine pregnancy tests (MLPTs) performed before and after treatment.

Study Design: We collated original data from seven studies performed by our organization that evaluated the accuracy of the MLPT strategy for assessment of outcome of medical abortion. Our first analysis included data from the five studies in which each participant was evaluated both with the MLPT strategy and with ultrasound or other clinical assessment. Our second analysis combined data from two randomized trials that compared the MLPT strategy to assessment by ultrasound. Both analyses included only participants treated at ≤63 days of gestation.

Results: In the first analysis, 1482 (93%) of 1599 participants had a decline in hCG concentration after treatment. Twenty-one (1.3%) had an ongoing pregnancy, none of whom had a decline (predictive value 100%, 95% CI 93.3%, 100%). The remaining 96 women (6.0%) had no decline without an ongoing pregnancy. The second analysis, which included 3762 participants with follow-up, found no significant difference in the rates of ongoing pregnancy ascertained in the randomized groups (RR 0.88; 95% CI 0.50, 1.54). Nearly all of the post-treatment MLPTs in the seven studies (3484/3535; 99%) were performed by the participants themselves.

Conclusions: Serial multilevel urine pregnancy testing is a highly reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at≤63 days of gestation.

Implications Statement: Serial urine testing using MLPTs can obviate the need for routine ultrasound or examination after medical abortion treatment and can allow most women to avoid an in-person follow-up visit to the abortion facility.
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http://dx.doi.org/10.1016/j.contraception.2016.12.004DOI Listing
May 2017

Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

Obstet Gynecol 2016 10;128(4):739-45

Gynuity Health Projects, New York, New York; the Departments of Medicine and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; the Secretariat of Health, Mexico City, Mexico; Planned Parenthood League of Massachusetts, Boston, Massachusetts; Planned Parenthood of the Pacific Southwest, San Diego, California; Planned Parenthood of Southern New England, New Haven, Connecticut; Planned Parenthood Northern California, San Rafael, California; the Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and Johns Hopkins University, Baltimore, Maryland.

Objective: To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months.

Methods: In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months.

Results: From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment.

Conclusion: Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy.

Clinical Trial Registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.
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http://dx.doi.org/10.1097/AOG.0000000000001627DOI Listing
October 2016

Increasing Access to Abortion With Telemedicine.

JAMA Intern Med 2016 05;176(5):585-6

Tabbot Foundation, Sydney, Australia.

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http://dx.doi.org/10.1001/jamainternmed.2016.0573DOI Listing
May 2016

Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

Obstet Gynecol 2016 Feb;127(2):306-12

Gynuity Health Projects, New York, New York; the Departments of Medicine and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Secretariat of Health, Mexico City, Mexico; Planned Parenthood of Southern New England, New Haven, Connecticut; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Planned Parenthood League of Massachusetts, Boston, Massachusetts; Planned Parenthood of the Pacific Southwest, San Diego, California; Planned Parenthood Northern California, San Rafael, California; and Johns Hopkins University, Baltimore, Maryland.

Objective: To evaluate the effect of insertion of etonogestrel implants with mifepristone compared with after the abortion on the risks of medical abortion failure and repeat pregnancy over the subsequent 6 months.

Methods: In a randomized trial, we assigned patients undergoing medical abortion to receive etonogestrel implants either with the mifepristone (Quickstart group) or after the abortion (Afterstart group). We followed them for 7 months to ascertain abortion outcome, pregnancies, and contraception use.

Results: Between September 2013 and August 2014, we enrolled 236 participants in the Quickstart group and 240 in the Afterstart group. To examine abortion failure, we conducted a noninferiority analysis from which we excluded nine participants who had missing outcome data and four with specified protocol violations. Of the rest, 9 of 229 (3.9%) and 9 of 234 (3.8%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the difference of 0.08% (90% confidence interval -3.1% to 3.3%) excluded our prestipulated noninferiority margin of 5 percentage points. Among participants with pregnancy follow-up through 6 months, 1 of 213 (0.5%) and 3 of 208 (1.4%) in the Quickstart and Afterstart groups, respectively, became pregnant within that time; 6-month pregnancy rates did not differ significantly by group (exact log-rank test, P=.28). At enrollment, significantly more participants in the Quickstart group than in the Afterstart group were satisfied with their group assignments (187/236 [79%] compared with 129/240 [54%], respectively; P<.001).

Conclusion: Insertion of etonogestrel implants with mifepristone did not appreciably increase medical abortion failure risk and it enhanced patient satisfaction, but we found no evidence that it decreased repeat pregnancy rates.

Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01902485.
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http://dx.doi.org/10.1097/AOG.0000000000001274DOI Listing
February 2016

Reaching women where they are: eliminating the initial in-person medical abortion visit.

Contraception 2015 Sep 29;92(3):190-3. Epub 2015 Jun 29.

Gynuity Health Projects, 15 E 26th Street, Suite 801, New York, NY, 10010, USA. Electronic address:

The requirement that every woman desiring medical abortion must come in person to a clinical facility to obtain the drugs is a substantial barrier for many women. To eliminate this requirement in the United States, two key components of the standard initial visit would need to be restructured. First, alternatives to ultrasound and pelvic exam would need to be identified for ensuring that gestational age is within the limit for safe and effective treatment. This is probably feasible: for example, data from a large study suggest that in selected patients menstrual history is highly sensitive for this purpose. Second, the Food and Drug Administration would need to remove the medically unwarranted restriction on distribution of mifepristone. These two changes could allow provision of the service by a broader range of providers in nontraditional venues or even by telemedicine. Such options could have profound benefits in reducing cost and expanding access to abortion.
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http://dx.doi.org/10.1016/j.contraception.2015.06.020DOI Listing
September 2015

Outpatient medical abortion is safe and effective through 70 days gestation.

Contraception 2015 Sep 26;92(3):197-9. Epub 2015 Jun 26.

Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY 10010, USA.

Data show that an outpatient regimen of 200-mg mifepristone followed by a single dose of misoprostol is safe and effective for medical abortion for up to 70 days from last menstrual period (LMP). Yet, many clinics only provide services up to 63 days LMP, and some practice guidelines do not recommend the higher gestational age limit. We review the studies published to date that include women 64 to 70 days LMP and conclude that outpatient medical abortion is safe and effective in this interval and that there are no clinically meaningful differences between outcomes at 57 to 63 days LMP and 64 to 70 days LMP. Updating clinical protocols and revising the Food and Drug administration label for Mifeprex® to change the indication for termination of pregnancies through 70 days LMP will give women more choices and expand access to safe abortion services.
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http://dx.doi.org/10.1016/j.contraception.2015.06.018DOI Listing
September 2015

Early medical abortion without prior ultrasound.

Contraception 2015 Sep 24;92(3):212-4. Epub 2015 Apr 24.

Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY 10010, USA. Electronic address:

Objective: To explore the potential for using last menstrual period (LMP) rather than ultrasound to establish gestational age (GA) eligibility for medical abortion.

Study Design: We used the results of a recently published systematic review to identify studies with data on the number of abortion patients with GA more than 63 or 70 days by ultrasound but less than those or other specific limits by LMP. We analyzed data from these studies to estimate the proportion of women with GAs greater than 63 or 70 days by ultrasound in various subgroups of women defined by LMP.

Results: We found three studies with relevant data. One enrolled 4257 medical abortion patients of whom 4% had GAs of >70 days by ultrasound. Of the 2681 who were certain that their LMPs began no more than 56 days prior, only 16 (0.6%) were >70 days by ultrasound. In a second much smaller study of surgical abortion patients, of whom 19% were >70 days by ultrasound, 90 women were certain that their LMPs started more than 56 days prior, and of those, 7 (7.8%) had GAs of >70 days by ultrasound. In the third study, which included surgical abortion patients with a mean GA of 61 days, at least 12% of the 138 patients with LMPs <63 days prior were >70 days by ultrasound.

Conclusion: The possibility that access to medical abortion can be enhanced for selected women by omitting the requirement for a screening ultrasound is promising and should be further investigated.

Implications: Gestational dating using LMP rather than ultrasound may be reasonable for selected patients before medical abortion.
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http://dx.doi.org/10.1016/j.contraception.2015.04.008DOI Listing
September 2015

Clinical practice. Emergency contraception.

N Engl J Med 2015 Apr;372(14):1342-8

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http://dx.doi.org/10.1056/NEJMcp1406328DOI Listing
April 2015

Repeated use of pre- and postcoital hormonal contraception for prevention of pregnancy.

Cochrane Database Syst Rev 2014 Sep 26(9):CD007595. Epub 2014 Sep 26.

Clinical Sciences, FHI 360, 359 Blackwell St, Suite 200, Durham, North Carolina, USA, 27701.

Background: Repeated use of postcoital hormonal contraception is not currently recommended due to the higher risk of side effects and lower contraceptive effectiveness compared to other modern methods of contraception. However, emerging evidence indicates renewed interest in a regular coitally-dependent method of oral contraception. We evaluated the existing data on safety and effectiveness of pericoital use of levonorgestrel and other hormonal drugs to prevent pregnancy.

Objectives: To determine the effectiveness and safety of repeated use of pre- and postcoital hormonal contraception for pregnancy prevention.

Search Methods: We searched until 1 September 2014 for trials that tested repeated pre- and postcoital use of hormonal drugs for pregnancy prevention. Databases included CENTRAL, MEDLINE, and POPLINE. We searched for current trials via ClinicalTrials.gov and ICTRP. For the initial review, we also searched EMBASE, CINAHL, and LILACS, and wrote to researchers to identify other trials.

Selection Criteria: We considered published and unpublished studies of repeated postcoital or immediately precoital use of hormonal drugs for contraception with pregnancy as an outcome.

Data Collection And Analysis: Two authors independently confirmed eligibility and extracted data from the included studies. We calculated confidence intervals (CI) around individual study Pearl indices using a Poisson distribution. We presented individual study estimates and pooled estimates and their 95% CI, where appropriate.

Main Results: We found 22 trials that evaluated pericoital use of LNG and other hormonal drugs on a regular basis to prevent pregnancy. The studies included a total of 12,400 participants, and were conducted in Europe, Asia, and the Americas. The drugs and doses evaluated included levonorgestrel (LNG) 0.75 mg (11 studies), LNG in doses other than 0.75 mg (4 trials), and hormones other than LNG (7 trials). Outcomes included pregnancy rates, discontinuation, side effects, and acceptability.Pericoital levonorgestrel was reasonably efficacious and safe. The pooled Pearl Index for the 0.75 mg dose of LNG was 5.4 per 100 woman-years (95% CI 4.1 to 7.0). The pooled Pearl Index for all doses of LNG was 5.0 per 100 woman-years (95% CI 4.4 to 5.6). Other hormonal drugs appeared promising but most of them were not studied extensively. Menstrual irregularities were the most common side effects reported. However, the studies provided no consistent evidence of a relationship between bleeding abnormalities and either frequency of pill intake or total dose of the drug. Non-menstrual side effects were reportedly mild and not tabulated in most studies. Most women liked the pericoital method in spite of frequent menstrual irregularities.

Authors' Conclusions: The studies of pericoital LNG regimens provided promising results but many had serious methodological issues. Most reports were decades old and provided limited information. However, we considered the evidence to be moderate quality because of the large number of participants from diverse populations, the low pregnancy rates, and the consistent results across studies. Rigorous research is still needed to confirm the efficacy and safety of pericoital use of LNG as a primary means of contraception among women with infrequent intercourse. If the method is shown to be efficacious, safe and acceptable, the results may warrant revision of the current World Health Organization recommendations and marketing strategies.
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http://dx.doi.org/10.1002/14651858.CD007595.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7196890PMC
September 2014

Emergency contraception review: evidence-based recommendations for clinicians.

Clin Obstet Gynecol 2014 Dec;57(4):741-50

*Office of Population Research, Princeton University, Princeton, New Jersey †Gynuity Health Projects ‡Family Care International, New York, New York.

Several options for emergency contraception are available in the United States. This article describes each method, including efficacy, mode of action, safety, side effect profile, and availability. The most effective emergency contraceptive is the copper intrauterine device (IUD), followed by ulipristal acetate and levonorgestrel pills. Levonorgestrel is available for sale without restrictions, whereas ulipristal acetate is available with prescription only, and the copper IUD must be inserted by a clinician. Although EC pills have not been shown to reduce pregnancy or abortion rates at the population level, they are an important option for individual women seeking to prevent pregnancy after sex.
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http://dx.doi.org/10.1097/GRF.0000000000000056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216625PMC
December 2014

Mortality of induced abortion, other outpatient surgical procedures and common activities in the United States.

Contraception 2014 Nov 24;90(5):476-9. Epub 2014 Jul 24.

Gynuity Health Projects, 15 E 26th Street, Suite 801, New York, NY, 10010, USA. Electronic address:

Objective: The recent surge of new legislation regulating induced abortion in the United States is ostensibly motivated by the desire to protect women's health. To provide context for interpreting the risk of abortion, we compared abortion-related mortality to mortality associated with other outpatient surgical procedures and selected nonmedical activities.

Methods: We calculated the abortion-related mortality rate during 2000-2009 using national data. We searched PubMed and other sources for contemporaneous data on mortality associated with other outpatient procedures commonly performed on healthy young women, marathon running, bicycling and driving.

Results: The abortion-related mortality rate in 2000-2009 in the United States was 0.7 per 100,000 abortions. Studies in approximately the same years found mortality rates of 0.8-1.7 deaths per 100,000 plastic surgery procedures, 0-1.7deaths per 100,000 dental procedures, 0.6-1.2 deaths per 100,000 marathons run and at least 4 deaths among 100,000 cyclists in a large annual bicycling event. The traffic fatality rate per 758 vehicle miles traveled by passenger cars in the United States in 2007-2011 was about equal to the abortion-related mortality rate.

Conclusions: The safety of induced abortion as practiced in the United States for the past decade met or exceeded expectations for outpatient surgical procedures and compared favorably to that of two common nonmedical voluntary activities. The new legislation restricting abortion is unnecessary; indeed, by reducing the geographic distribution of abortion providers and requiring women to travel farther for the procedure, these laws are potentially detrimental to women's health.
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http://dx.doi.org/10.1016/j.contraception.2014.07.012DOI Listing
November 2014

What some women want? On-demand oral contraception.

Contraception 2014 Aug 21;90(2):105-10. Epub 2014 Apr 21.

International Consortium for Emergency Contraception, hosted by Family Care International, New York, NY, USA.

Objective: To summarize evidence regarding current demand for on-demand oral contraception.

Study Design: We used Medline and collegial contacts to find published and unpublished studies conducted or reported in the past 15 years with information assessing women's interest in using any oral drug preparation, including emergency contraceptive pills, in a coitus-dependent manner either repeatedly or as a primary or planned pregnancy prevention method.

Results: We found 19 studies with relevant information. The studies were conducted in 16 countries. Eight studies provided data on women's attitudes regarding a coitus-dependent oral contraceptive; all suggested substantial interest in using it. Nine studies assessed actual use of oral tablets on demand for primary contraception. In these studies, 9-97% of women in the analysis populations reported using the pills on demand as main method, although frequency and consistency of use varied. Reported reasons for interest in or use of this contraceptive approach included convenience, ease of remembering, ability to conceal use, lack of coital interruption, and infrequent sexual activity. Three studies were clinical trials of investigational on-demand oral contraceptives which reported Pearl indices ranging from 6.8 to 53 pregnancies per 100 woman-years.

Conclusion: Data from a variety of settings suggest that demand for an on-demand oral contraceptive may be widespread. The effectiveness of this potential method is not established, however. Considering the seriousness of the unmet need for contraception, further development research into the public health benefits and risks of such a method would be worthwhile.

Implications: Demand for an on-demand oral contraceptive may be widespread. Efforts should be made to further explore the possibility of developing such a method.
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http://dx.doi.org/10.1016/j.contraception.2014.04.008DOI Listing
August 2014

A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel.

Contraception 2014 Mar 26;89(3):215-21. Epub 2013 Nov 26.

Gynuity Health Projects, New York, NY 10010, USA.

Background: An oral dose of 0.75 mg levonorgestrel (LNG) taken shortly after sex was marketed as a routine, nonemergency contraceptive method until the 1990s. Because a hormonal method used only at the time of intercourse may be desirable for women who have infrequent sex, we conducted a study to reevaluate the potential of pericoital LNG as a primary means of contraception.

Methods: We enrolled women aged 18-45 years in Brazil and the USA who expected to have sex 1-4 days per month for 6.5 months. Participants were instructed to take one tablet 0.75 mg LNG within 24 h before or after sex, with no more than one dose in any 24-h period. The primary efficacy measure was the Pearl Index among women aged 18-35 years.

Results: The study was stopped after 72 of the planned 300 participants were enrolled due to slow recruitment and related feasibility considerations. In the primary analysis, three pregnancies occurred during 13.4 woman-years of follow-up, resulting in a Pearl Index of 22.4 (95% confidence interval, 4.6-65.4). No serious adverse events were reported, and vaginal bleeding patterns were generally acceptable.

Conclusions: Our estimated Pearl Index was noticeably higher than expected from previous research of LNG for pericoital contraception. Although the regimen was safe and generally acceptable, the study was challenged by slow enrollment and curtailed person-years of follow-up, resulting in poor precision for the estimated treatment effect. Future research may inform whether our results are symptomatic of the regimen, study design or characteristics of the populations from which we recruited.

Implications: Our study failed to confirm prior data suggesting that 0.75 mg LNG for pericoital contraception could be more effective than typical use of barrier methods among women having infrequent sex. Characterizing populations most likely to adhere to, and benefit from, pericoital regimens is essential to future research on these methods.
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http://dx.doi.org/10.1016/j.contraception.2013.11.013DOI Listing
March 2014

Comment on 'Embracing post-fertilisation methods of family planning: a call to action': authors' response.

J Fam Plann Reprod Health Care 2014 Jan;40(1):73-4

Senior Medical Associate, Gynuity Health Projects, New York, NY, USA;

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http://dx.doi.org/10.1136/jfprhc-2013-100825DOI Listing
January 2014

Spermicide used alone for contraception.

Cochrane Database Syst Rev 2013 Dec 5(12):CD005218. Epub 2013 Dec 5.

Obstetrics and Gynecology, University of North Carolina, School of Medicine, CB#7570, Chapel Hill, North Carolina, USA, 27599-7570.

Background: Spermicides have been used as contraceptives for thousands of years. Despite this long use, only recently have studies examined the comparative efficacy and acceptability of these vaginal medications. Spermicides contain an active ingredient (most commonly nonoxynol-9) and a formulation used to disperse the product, such as foam or vaginal suppository.

Objectives: This review examined all known randomized controlled trials of a spermicide used alone for contraception.

Search Methods: In August 2013, we searched the following computerized databases for randomized controlled trials of spermicides for contraception: CENTRAL, MEDLINE, POPLINE, LILACS, EMBASE, ClinicalTrials.gov, and ICTRP. For the initial review, we examined the reference lists of trials found as well as those of review articles and textbook chapters.

Selection Criteria: We included any trial of a commercial product used alone for contraception. Each included trial must have provided sufficient information to determine pregnancy rates.

Data Collection And Analysis: Two authors independently extracted information from the trials identified. We did not conduct a meta-analysis, since most trials had large losses to follow up. We entered the data into tables and presented the results descriptively.

Main Results: We located reports from 14 trials for the initial review, but have not identified any new trials since then. In the largest trial to date, the gel (Advantage S) containing the lowest dose of nonoxynol-9 (52.5 mg) was significantly less effective in preventing pregnancy than were gels with higher doses of the same agent (100 mg and 150 mg). Probabilities of pregnancy by six months were 22% for the 52.5 mg gel, 16% for the 100 mg dose, and 14% for the 150 mg dose. In the same trial, the three different vehicles with 100 mg of nonoxynol-9 had similar efficacy. Interpretation of these figures is limited, since 39% of participants discontinued the method or were lost from the trial. Few important differences in efficacy emerged in other trials.

Authors' Conclusions: The probability of pregnancy varied widely in reported trials. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial. Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. Gel was liked more than the film or vaginal suppository in the largest trial. Spermicide trials have the dual challenges of difficult recruitment and high discontinuation rates; the latter threatens trial validity.
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http://dx.doi.org/10.1002/14651858.CD005218.pub4DOI Listing
December 2013

Progestin-only pills for contraception.

Cochrane Database Syst Rev 2013 Nov 13(11):CD007541. Epub 2013 Nov 13.

Obstetrics and Gynecology, University of North Carolina, School of Medicine, CB#7570, Chapel Hill, North Carolina, USA, 27599-7570.

Background: The introduction of a new progestin-only oral contraceptive in Europe has renewed interest in this class of oral contraceptives. Unlike the more widely used combined oral contraceptives containing an estrogen plus progestin, these pills contain only a progestin (progestogen) and are taken without interruption. How these pills compare to others in their class or to combined oral contraceptives is not clear.

Objectives: This review examined randomized controlled trials of progestin-only pills for differences in efficacy, acceptability, and continuation rates.

Search Methods: Through October 2013, we searched the computerized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, and LILACS for studies of progestin-only pills. We also searched for current trials via ClinicalTrials.gov and ICTRP. Previous searches also included EMBASE.

Selection Criteria: We included all randomized controlled trials in any language that included progestin-only pills for contraception.  We incorporated any comparison with a progestin-only pill; this could include different doses, other progestin-only pills, combined oral contraceptives, or other contraceptives.

Data Collection And Analysis: The first author abstracted the data and entered the information into RevMan 5. Another author performed a second, independent data abstraction to verify the initial data entry.We attempted to extract life-table rates (actuarial or continuous) and used the rate difference as the effect measure. Where life-table rates were not published, we used the incidence rate ratio (ratio of Pearl rates). Where only the crude number of events was published, we calculated the Peto odds ratio with 95% confidence interval (CI) using a fixed-effect model. For continuous variables, the mean difference (MD) was computed with 95% CI. Because of disparate exposures, we were not able to combine studies in meta-analysis.

Main Results: Six trials met the inclusion criteria. We have not found any new studies since the initial review. In the trial comparing the desogestrel versus levonorgestrel progestin-only pill, desogestrel was not associated with a significantly lower risk of accidental pregnancy; the rate ratio was 0.27 (95% CI 0.06 to 1.19). However, the desogestrel progestin-only pill caused more bleeding problems, although this difference was not statistically significant. The trial comparing low-dose mifepristone versus a levonorgestrel progestin-only pill found similar pregnancy rates. In the trial comparing ethynodiol diacetate versus a combined oral contraceptive, irregular cycles occurred in all women assigned to the progestin-only pill (odds ratio 135.96; 95% CI 7.61 to 2421.02). In a trial comparing two progestin-only and two combined oral contraceptives, the progestin-only pill containing levonorgestrel 30 μg had higher efficacy than did the pill containing norethisterone 350 μg. An early trial found megestrol acetate inferior to other progestin-only pills in terms of efficacy. A study of the timing of pill initiation after birth found no important differences, but high losses to follow up undermined the trial.

Authors' Conclusions: Evidence is insufficient to compare progestin-only pills to each other or to combined oral contraceptives.
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November 2013

Spermicide used alone for contraception.

Cochrane Database Syst Rev 2013 Sep 30(9):CD005218. Epub 2013 Sep 30.

Obstetrics and Gynecology, University of North Carolina, School of Medicine, CB#7570, Chapel Hill, North Carolina, USA, 27599-7570.

Background: Spermicides have been used as contraceptives for thousands of years. Despite this long use, only recently have studies examined the comparative efficacy and acceptability of these vaginal medications. Spermicides contain an active ingredient (most commonly nonoxynol-9) and a formulation used to disperse the product, such as foam or vaginal suppository.

Objectives: This review examined all known randomized controlled trials of a spermicide used alone for contraception.

Search Methods: In August 2013, we searched the following computerized databases for randomized controlled trials of spermicides for contraception: CENTRAL, MEDLINE, POPLINE, LILACS, EMBASE, ClinicalTrials.gov, and ICTRP. For the initial review, we examined the reference lists of trials found as well as those of review articles and textbook chapters.

Selection Criteria: We included any trial of a commercial product used alone for contraception. Each included trial must have provided sufficient information to determine pregnancy rates.

Data Collection And Analysis: Two authors independently extracted information from the trials identified. We did not conduct a meta-analysis, since most trials had large losses to follow up. We entered the data into tables and presented the results descriptively.

Main Results: We located reports from 14 trials for the initial review, but have not identified any new trials since then. In the largest trial to date, the gel (Advantage S) containing the lowest dose of nonoxynol-9 (52.5 mg) was significantly less effective in preventing pregnancy than were gels with higher doses of the same agent (100 mg and 150 mg). Probabilities of pregnancy by six months were 22% for the 52.5 mg gel, 16% for the 100 mg dose, and 14% for the 150 mg dose. In the same trial, the three different vehicles with 100 mg of nonoxynol-9 had similar efficacy. Interpretation of these figures is limited, since 39% of participants discontinued the method or were lost from the trial. Few important differences in efficacy emerged in other trials.

Authors' Conclusions: The probability of pregnancy varied widely in reported trials. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial. Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. Gel was liked more than the film or vaginal suppository in the largest trial. Spermicide trials have the dual challenges of difficult recruitment and high discontinuation rates; the latter threatens trial validity.
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http://dx.doi.org/10.1002/14651858.CD005218.pub3DOI Listing
September 2013
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