Publications by authors named "Anjali Kaimal"

90 Publications

Derivation and external validation of risk stratification models for severe maternal morbidity using prenatal encounter diagnosis codes.

J Perinatol 2021 May 19. Epub 2021 May 19.

Center for Quantitative Health, Massachusetts General Hospital, Boston, MA, USA.

Objective: We sought to develop a prediction model using prenatal diagnosis codes that could help clinicians objectively stratify a women's risk for delivery-related morbidity.

Study Design: We performed a prospective cohort study of women delivering at a single academic medical center between 2016 and 2019. Diagnosis codes from outpatient encounters were extracted from the electronic health record. Standard and common machine-learning methods for variable selection were compared. The performance characteristics from the selected model in the training data set-a LASSO model with a lambda that minimized the Bayes information criteria-were compared in a testing and external validation set.

Results: The model identified a group of women, those in the highest decile of predicted risk, who were at a two to threefold increased risk of maternal morbidity.

Conclusion: As EHR data becomes more ubiquitous, other data types generated from the prenatal period may improve the model's performance.
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http://dx.doi.org/10.1038/s41372-021-01072-zDOI Listing
May 2021

Outcomes of the First Pregnancy After Fertility-Sparing Surgery for Early-Stage Ovarian Cancer.

Obstet Gynecol 2021 06;137(6):1109-1118

Department of Gynecologic Oncology and Reproductive Medicine, the Department of Health Services Research, Division of Cancer Prevention and Population Sciences, and the Department of Breast Medical Oncology, the University of Texas MD Anderson Cancer Center, Houston, Texas; the Department of Obstetrics and Gynecology, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; the Department of Obstetrics and Gynecology, the University of Texas Medical Branch at Galveston, Galveston, Texas; and the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, and the Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, New York.

Objective: To evaluate the outcomes of the first pregnancy after fertility-sparing surgery in patients treated for early-stage ovarian cancer.

Methods: We performed a retrospective study of women aged 18-45 years with a history of stage IA or IC ovarian cancer reported to the California Cancer Registry for the years 2000-2012. These data were linked to the 2000-2012 California Office of Statewide Health Planning and Development birth and discharge data sets to ascertain oncologic characteristics and obstetric outcomes. We included in the case group ovarian cancer patients who conceived at least 3 months after fertility-sparing surgery. The primary outcome was preterm birth, and only the first pregnancy after cancer diagnosis was considered. Secondary outcomes included small-for-gestational-age (SGA) neonates, neonatal morbidity (respiratory support within 72 hours after birth, hypoxic-ischemic encephalopathy, seizures, infection, meconium aspiration syndrome, birth trauma, and intracranial or subgaleal hemorrhage), and severe maternal morbidity as defined by the Centers for Disease Control and Prevention. Propensity scores were used to match women in a 1:2 ratio for the case group and the control group. Wald statistics and logistic regressions were used to evaluate outcomes.

Results: A total of 153 patients who conceived after fertility-sparing surgery were matched to 306 women in a control group. Histologic types included epithelial (55%), germ-cell (37%), and sex-cord stromal (7%). Treatment for ovarian cancer was not associated with preterm birth before 37 weeks of gestation (13.7% vs 11.4%; odds ratio [OR] 1.23, 95% CI 0.69-2.20), SGA neonates (birth weight less than the 10th percentile: 11.8% vs 12.7%; OR 0.91, 95% CI 0.50-1.66), severe maternal morbidity (2.6% vs 1.3%; OR 2.03, 95% CI 0.50-8.25), or neonatal morbidity (both 5.9% OR 1.00, 95% CI 0.44-2.28).

Conclusion: Patients who conceived at least 3 months after surgery for early-stage ovarian cancer did not have an increased risk of adverse obstetric outcomes.
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http://dx.doi.org/10.1097/AOG.0000000000004394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141030PMC
June 2021

Vertical transmission of SARS-CoV-2: consider the denominator.

Am J Obstet Gynecol MFM 2021 Apr 29;3(4):100386. Epub 2021 Apr 29.

Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA; Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1016/j.ajogmf.2021.100386DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081748PMC
April 2021

The use of a validated obstetrical risk score for maternal morbidity to predict postpartum hemorrhage for women in labor.

Am J Obstet Gynecol 2021 Apr 23. Epub 2021 Apr 23.

Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA; Department of Population Medicine, Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1016/j.ajog.2021.04.243DOI Listing
April 2021

Comparison of Maternal and Neonatal Subspecialty Care Provision by Hospital.

Am J Perinatol 2021 Apr 20. Epub 2021 Apr 20.

Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts.

Objective:  The aim of the study is to determine the relationship between a hospital's provision of subspecialty neonatal and maternal care. Specifically, we sought to understand where women with high-risk maternal conditions received intrapartum care and estimate the potential transfer burden for those with maternal high-risk conditions delivering at hospitals without subspecialty maternal care.

Study Design:  This is a descriptive study using data from 2015 State Inpatient Databases and the American Hospital Association Annual Survey. Characteristics were compared between hospitals based on the concordance of their maternal and neonatal care. The incidences of high-risk maternal conditions (pre-eclampsia with severe features, placenta previa with prior cesarean delivery, cardiac disease, pulmonary edema, and acute liver failure) were compared. To determine the potential referral burden, the percent of women with high-risk conditions delivering at a hospital without subspecialty maternal care but delivering in a county with a hospital with subspecialty maternal care was calculated.

Results:  The analysis included 486,398 women who delivered at 544 hospitals, of which 104 (19%) and 182 (33%) had subspecialty maternal and neonatal care, respectively. Ninety-eight hospitals provided both subspecialty maternal and neonatal care; however, 84 hospitals provided only subspecialty neonatal care but no subspecialty maternal care. Among high-risk maternal conditions examined, approximately 65% of women delivered at a hospital with subspecialty maternal care. Of the remainder who delivered at a hospital without subspecialty maternal care, one-third were in a county where subspecialty care was present. For women with high-risk conditions who delivered in a county without subspecialty maternal care, the median distance to the closest county with subspecialty care was 52.8 miles (IQR 34.3-87.7 miles).

Conclusion:  Approximately 50% of hospitals with subspecialty neonatal care do not provide subspecialty maternal care. This discordance may present a challenge when both high-risk maternal and neonatal conditions are present.

Key Points: · High-risk women who deliver at hospitals without subspecialty care are in more rural areas.. · Approximately 50% of hospitals with subspecialty neonatal care do not provide subspecialty maternal care.. · This discordance may present a challenge when both high-risk maternal and neonatal conditions are present..
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http://dx.doi.org/10.1055/s-0041-1727223DOI Listing
April 2021

Association of sexual assault history with traumatic childbirth and subsequent PTSD.

Arch Womens Ment Health 2021 Apr 13. Epub 2021 Apr 13.

Department of Psychiatry, Massachusetts General Hospital, 120 2nd Ave, Boston, MA, USA.

Although childbirth-related posttraumatic stress (CB-PTSD) has received recognition, how sexual assault (SA) history influences obstetrical and traumatic stress outcomes remains unclear. Six hundred eighty-three women provided information about their childbirth and mental health. Obstetric complications and unplanned cesareans were more prevalent among women with SA history. They also had higher rates of probable CB-PTSD and were two times more likely to have premature deliveries than women without SA history. Screening women for history of sexual trauma is warranted to optimize birth outcomes.
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http://dx.doi.org/10.1007/s00737-021-01129-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8041617PMC
April 2021

Sexually dimorphic placental responses to maternal SARS-CoV-2 infection.

bioRxiv 2021 Mar 29. Epub 2021 Mar 29.

There is a persistent male bias in the prevalence and severity of COVID-19 disease. Underlying mechanisms accounting for this sex difference remain incompletely understood. Interferon responses have been implicated as a modulator of disease in adults, and play a key role in the placental anti-viral response. Moreover, the interferon response has been shown to alter Fc-receptor expression, and therefore may impact placental antibody transfer. Here we examined the intersection of viral-induced placental interferon responses, maternal-fetal antibody transfer, and fetal sex. Placental interferon stimulated genes (ISGs), Fc-receptor expression, and SARS-CoV-2 antibody transfer were interrogated in 68 pregnancies. Sexually dimorphic placental expression of ISGs, interleukin-10, and Fc receptors was observed following maternal SARS-CoV-2 infection, with upregulation in males. Reduced maternal SARS-CoV-2-specific antibody titers and impaired placental antibody transfer were noted in pregnancies with a male fetus. These results demonstrate fetal sex-specific maternal and placental adaptive and innate immune responses to SARS-CoV-2.
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http://dx.doi.org/10.1101/2021.03.29.437516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8020979PMC
March 2021

Utility of noninvasive genome-wide screening: a prospective cohort of obstetric patients undergoing diagnostic testing.

Genet Med 2021 Mar 29. Epub 2021 Mar 29.

Division of Maternal-Fetal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Purpose: Copy-number variant (CNV) assessment is recommended for patients undergoing prenatal diagnostic testing. Noninvasive screening tests have not been extensively validated for CNV detection. The objective of this study was to compare the ability of genome-wide noninvasive prenatal screening (NIPS) to chromosomal microarray to detect clinically significant findings.

Methods: We prospectively enrolled 198 subjects at the time of consent for diagnostic prenatal testing. Genome-wide NIPS results were compared with diagnostic testing results to assess NIPS test performance (n = 160, 38 subjects without microarray results excluded). Cohen's kappa statistic was used to assess test agreement.

Results: Genome-wide NIPS did not detect clinically significant chromosomal abnormalities at the same rate as diagnostic testing, κ = 0.75 (95% confidence interval [CI], 0.62-0.87). When excluding CNVs <7 Mb and findings outside the limits of genome-wide NIPS, test agreement improved, κ = 0.88 (0.79-0.97) driven by agreement for common aneuploidies (κ = 1.0). However, among patients with an abnormal fetal survey, agreement was only fair, κ = 0.38 (0.08-0.67).

Conclusion: While NIPS is an excellent screening test for common aneuploidies, genome-wide NIPS misses clinically significant findings detected on routine diagnostic testing. False positive and false negative cases highlight the importance of pretest counseling regarding NIPS limitations, especially in the setting of fetal anomalies.
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http://dx.doi.org/10.1038/s41436-021-01147-4DOI Listing
March 2021

Incidence of and Risk Factors for Failed Induction of Labor Using a Contemporary Definition.

Obstet Gynecol 2021 Mar;137(3):497-504

Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

Objective: To estimate the incidence of failed induction of labor and the associated patient risk factors.

Methods: We performed a case-control study from a cohort of nulliparous women who delivered between 39 and 41 weeks of gestation after an induction of labor in one of seven hospitals. Cases of failed induction were defined using the Obstetric Care Consensus criteria (ie, cesarean delivery performed in early labor [less than 6 cm dilatation] after at least 12 hours of oxytocin administration from membrane rupture). For each case of failed induction, the next four women who did not meet the criteria for failed induction of labor were selected for the control group, matched by hospital. We identified characteristics associated with failed induction of labor using a multivariable conditional logistic regression that was constructed with backward stepwise method for variable selection.

Results: Across the hospitals, 4,123 of 10,175 nulliparous women were induced (40.5%), of whom 82 had a failed induction of labor (2.0%). A total of 328 women were selected for the matched control group. Baseline characteristics were similar between the groups. Compared with women in the control group, women with a failed induction were more likely to have a delivery body mass index (BMI) of 40 or higher (28.0 vs 8.2%, P<.001), shorter height (mean 63.9 vs 64.8 inches, P=.01), and closed cervix on admission (41.5 vs 24.1%, P=.002). Factors significantly associated with induction failure in the multivariable model included: 1) delivery BMI (adjusted odds ratio [aOR] 7.93, 95% CI 3.48-18.09, for BMI 40 or higher relative to BMI lower than 30, 2) height in inches (aOR 0.89, 95% CI 0.80-0.98), and 3) number of centimeters dilated on admission 2 or more (aOR 0.30, 95% CI 0.14-0.65).

Conclusion: Failed induction of labor occurs infrequently. Risk factors include shorter height, BMI 40 or higher, and cervical dilatation of less than 2 cm on admission. Even so, most women with these risk factors will not experience failed labor induction.
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http://dx.doi.org/10.1097/AOG.0000000000004257DOI Listing
March 2021

Compromised SARS-CoV-2-specific placental antibody transfer.

Cell 2021 02 23;184(3):628-642.e10. Epub 2020 Dec 23.

Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA 02139, USA. Electronic address:

SARS-CoV-2 infection causes more severe disease in pregnant women compared to age-matched non-pregnant women. Whether maternal infection causes changes in the transfer of immunity to infants remains unclear. Maternal infections have previously been associated with compromised placental antibody transfer, but the mechanism underlying this compromised transfer is not established. Here, we used systems serology to characterize the Fc profile of influenza-, pertussis-, and SARS-CoV-2-specific antibodies transferred across the placenta. Influenza- and pertussis-specific antibodies were actively transferred. However, SARS-CoV-2-specific antibody transfer was significantly reduced compared to influenza- and pertussis-specific antibodies, and cord titers and functional activity were lower than in maternal plasma. This effect was only observed in third-trimester infection. SARS-CoV-2-specific transfer was linked to altered SARS-CoV-2-antibody glycosylation profiles and was partially rescued by infection-induced increases in IgG and increased FCGR3A placental expression. These results point to unexpected compensatory mechanisms to boost immunity in neonates, providing insights for maternal vaccine design.
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http://dx.doi.org/10.1016/j.cell.2020.12.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755577PMC
February 2021

The utility of electronic health record data for identifying postpartum hemorrhage.

Am J Obstet Gynecol MFM 2021 03 6;3(2):100305. Epub 2021 Jan 6.

Center for Quantitative Health, Division of Clinical Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA.

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http://dx.doi.org/10.1016/j.ajogmf.2020.100305DOI Listing
March 2021

COVID-19 is associated with traumatic childbirth and subsequent mother-infant bonding problems.

J Affect Disord 2021 03 28;282:122-125. Epub 2020 Dec 28.

Massachusetts General Hospital, Department of Psychiatry, Boston, MA, USA; Harvard Medical School, Department of Psychiatry, Boston, MA, USA. Electronic address:

Background: Knowledge of women's experience of childbirth in the outbreak of the coronavirus (COVID-19) pandemic and associated maternal health outcomes is scarce.

Methods: A sample of primarily American women who gave birth around the height of COVID-19 (n = 1,611) and matched controls, i.e., women who gave birth before COVID-19 (n = 640), completed an anonymous Internet survey about recent childbirth, birth-related traumatic stress (peritraumatic distress inventory; PTSD-checklist), maternal bonding (maternal attachment inventory; mother-to-infant bonding scale) and breastfeeding status. Groups (n = 637 in each) were matched on demographics, prior mental health/trauma and childbirth factors to determine the unique contribution of COVID-19 to the psychological experience of childbirth.

Results: Mothers in COVID-19-exposed communities endorsed more clinically acute stress response to childbirth than matched controls (Z = 2.65, p = .008, OR= 1.38). A path mediation model revealed that acute stress mediated the relationship between study group and postpartum outcomes. Specifically, higher acute stress response in birth was associated with more childbirth-related posttraumatic stress disorder symptoms (β = .42, p < .001) and less bonding with the infant (β = .26, p < .001), including breastfeeding problems (β = .10, p < .01).

Limitations: Use of a convenient internet sample introduces bias towards more educated women and reliance on retrospective self-report assessments may entail recall bias.

Conclusions: COVID-19 is a major stressor for delivering women. It can heighten traumatic childbirth experiences and interfere with successful postpartum adjustment. Clinical attention to traumatic stress in childbirth and problems with caring for the young during this pandemic is important.
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http://dx.doi.org/10.1016/j.jad.2020.12.101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7889625PMC
March 2021

Assessment of Maternal and Neonatal SARS-CoV-2 Viral Load, Transplacental Antibody Transfer, and Placental Pathology in Pregnancies During the COVID-19 Pandemic.

JAMA Netw Open 2020 12 1;3(12):e2030455. Epub 2020 Dec 1.

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Importance: Biological data are lacking with respect to risk of vertical transmission and mechanisms of fetoplacental protection in maternal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Objective: To quantify SARS-CoV-2 viral load in maternal and neonatal biofluids, transplacental passage of anti-SARS-CoV-2 antibody, and incidence of fetoplacental infection.

Design, Setting, And Participants: This cohort study was conducted among pregnant women presenting for care at 3 tertiary care centers in Boston, Massachusetts. Women with reverse transcription-polymerase chain reaction (RT-PCR) results positive for SARS-CoV-2 were recruited from April 2 to June 13, 2020, and follow-up occurred through July 10, 2020. Contemporaneous participants without SARS-CoV-2 infection were enrolled as a convenience sample from pregnant women with RT-PCR results negative for SARS-CoV-2.

Exposures: SARS-CoV-2 infection in pregnancy, defined by nasopharyngeal swab RT-PCR.

Main Outcomes And Measures: The main outcomes were SARS-CoV-2 viral load in maternal plasma or respiratory fluids and umbilical cord plasma, quantification of anti-SARS-CoV-2 antibodies in maternal and cord plasma, and presence of SARS-CoV-2 RNA in the placenta.

Results: Among 127 pregnant women enrolled, 64 with RT-PCR results positive for SARS-CoV-2 (mean [SD] age, 31.6 [5.6] years) and 63 with RT-PCR results negative for SARS-CoV-2 (mean [SD] age, 33.9 [5.4] years) provided samples for analysis. Of women with SARS-CoV-2 infection, 23 (36%) were asymptomatic, 22 (34%) had mild disease, 7 (11%) had moderate disease, 10 (16%) had severe disease, and 2 (3%) had critical disease. In viral load analyses among 107 women, there was no detectable viremia in maternal or cord blood and no evidence of vertical transmission. Among 77 neonates tested in whom SARS-CoV-2 antibodies were quantified in cord blood, 1 had detectable immunoglobuilin M to nucleocapsid. Among 88 placentas tested, SARS-CoV-2 RNA was not detected in any. In antibody analyses among 37 women with SARS-CoV-2 infection, anti-receptor binding domain immunoglobin G was detected in 24 women (65%) and anti-nucleocapsid was detected in 26 women (70%). Mother-to-neonate transfer of anti-SARS-CoV-2 antibodies was significantly lower than transfer of anti-influenza hemagglutinin A antibodies (mean [SD] cord-to-maternal ratio: anti-receptor binding domain immunoglobin G, 0.72 [0.57]; anti-nucleocapsid, 0.74 [0.44]; anti-influenza, 1.44 [0.80]; P < .001). Nonoverlapping placental expression of SARS-CoV-2 receptors angiotensin-converting enzyme 2 and transmembrane serine protease 2 was noted.

Conclusions And Relevance: In this cohort study, there was no evidence of placental infection or definitive vertical transmission of SARS-CoV-2. Transplacental transfer of anti-SARS-CoV-2 antibodies was inefficient. Lack of viremia and reduced coexpression and colocalization of placental angiotensin-converting enzyme 2 and transmembrane serine protease 2 may serve as protective mechanisms against vertical transmission.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.30455DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756241PMC
December 2020

Society for Maternal-Fetal Medicine Consult Series #55: Counseling women at increased risk of maternal morbidity and mortality.

Am J Obstet Gynecol 2021 04 9;224(4):B16-B23. Epub 2020 Dec 9.

Society for Maternal-Fetal Medicine, 409 12 St. SW, Washington, DC 20024, USA.

Women should be provided with evidence-based information when considering options for contraception and pregnancy management. When counseling about health conditions and available treatments, healthcare practitioners should employ strategies that encourage the incorporation of informed patient preferences into a shared decision-making process with the patient. To optimize the health of women at risk of experiencing adverse health outcomes during or after pregnancy, counseling should be a continuous process throughout the reproductive life course. The purpose of this Consult is to provide guidance for all healthcare practitioners about counseling reproductive-aged women who may be at high risk of experiencing maternal morbidity or mortality.
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http://dx.doi.org/10.1016/j.ajog.2020.12.007DOI Listing
April 2021

In Reply.

Obstet Gynecol 2020 11;136(5):1062

American College of Obstetricians and Gynecologists, Washington, DC.

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http://dx.doi.org/10.1097/AOG.0000000000004143DOI Listing
November 2020

Prolonged Second Stage of Labor and Anal Sphincter Injury in a Contemporary Cohort of Term Nulliparas.

Am J Perinatol 2020 Oct 20. Epub 2020 Oct 20.

Division of Maternal Fetal Medicine Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts.

Objective:  This study aimed to assess whether a prolonged second stage of labor is an independent predictor of obstetric anal sphincter injury (OASI) in a contemporary cohort of nulliparous and term parturients, and to evaluate whether predelivery factors can accurately predict OASI.

Study Design:  This was a nested case-control study within a cohort of consecutive nulliparous term parturients with a singleton gestation who underwent a vaginal delivery at a single institution between January 2014 and January 2015. Cases were defined as women with a third- or fourth-degree laceration at the time of delivery, and controls were women without a third- or fourth-degree laceration. A prolonged second stage was defined as a second stage of ≥3 hours. Univariable and multivariable regression analyses were performed to examine the relationship between prolonged second stage of labor and third- or fourth-degree lacerations. Receiver operator curves were developed to assess the predictive capacity of predelivery information for third- and fourth-degree lacerations.

Results:  Of 1,197 births, 63 women had third- or fourth-degree lacerations (5.3%). With each additional hour of the second stage, the rate of OASI increased, with 2.9% of women with a second stage of <1 hour with OASI, 3.5% between 1 and 2 hours, 5.7% between 2 and 3 hours, 7.8% between 3 and 4 hours, 16.1% between 4 and 5 hours, and 28.6% among women with a second stage length >5 hours ( < 0.001). In multivariable regression analysis, operative vaginal delivery (adjusted odds ratio [aOR] = 5.92, 95% confidence interval [CI]: 3.17-11.07) and a prolonged second stage (aOR = 1.92, 95% CI: 1.06-3.51) were independent predictors of third- and fourth-degree lacerations. A predictive model was developed from these results (area under the curve [AUC] = 0.75, 95% CI: 0.68-0.81).

Conclusion:  Prolonged second stage of labor is a predictor of OASI, after adjustment for operative vaginal delivery. A model using predelivery risk factors has a reasonable prediction of OASI.

Key Points: · Prolonged second stage labor is associated with obstetric anal sphincter injury in term nulliparas.. · Predelivery risk factors reasonably predict obstetric anal sphincter injury in term nulliparas.. · Improved models are needed for clinical risk-stratification..
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http://dx.doi.org/10.1055/s-0040-1718878DOI Listing
October 2020

High Concentrations of Nitric Oxide Inhalation Therapy in Pregnant Patients With Severe Coronavirus Disease 2019 (COVID-19).

Obstet Gynecol 2020 12;136(6):1109-1113

Department of Anesthesia, the Department of Pediatrics, the Respiratory Care Department, the Department of Obstetrics and Gynecology, and the Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts; and the Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.

Background: Rescue therapies to treat or prevent progression of coronavirus disease 2019 (COVID-19) hypoxic respiratory failure in pregnant patients are lacking.

Method: To treat pregnant patients meeting criteria for severe or critical COVID-19 with high-dose (160-200 ppm) nitric oxide by mask twice daily and report on their clinical response.

Experience: Six pregnant patients were admitted with severe or critical COVID-19 at Massachusetts General Hospital from April to June 2020 and received inhalational nitric oxide therapy. All patients tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. A total of 39 treatments was administered. An improvement in cardiopulmonary function was observed after commencing nitric oxide gas, as evidenced by an increase in systemic oxygenation in each administration session among those with evidence of baseline hypoxemia and reduction of tachypnea in all patients in each session. Three patients delivered a total of four neonates during hospitalization. At 28-day follow-up, all three patients were home and their newborns were in good condition. Three of the six patients remain pregnant after hospital discharge. Five patients had two negative test results on nasopharyngeal swab for SARS-CoV-2 within 28 days from admission.

Conclusion: Nitric oxide at 160-200 ppm is easy to use, appears to be well tolerated, and might be of benefit in pregnant patients with COVID-19 with hypoxic respiratory failure.
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http://dx.doi.org/10.1097/AOG.0000000000004128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673637PMC
December 2020

Rapid establishment of a COVID-19 perinatal biorepository: early lessons from the first 100 women enrolled.

BMC Med Res Methodol 2020 08 26;20(1):215. Epub 2020 Aug 26.

Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.

Background: Collection of biospecimens is a critical first step to understanding the impact of COVID-19 on pregnant women and newborns - vulnerable populations that are challenging to enroll and at risk of exclusion from research. We describe the establishment of a COVID-19 perinatal biorepository, the unique challenges imposed by the COVID-19 pandemic, and strategies used to overcome them.

Methods: A transdisciplinary approach was developed to maximize the enrollment of pregnant women and their newborns into a COVID-19 prospective cohort and tissue biorepository, established on March 19, 2020 at Massachusetts General Hospital (MGH). The first SARS-CoV-2 positive pregnant woman was enrolled on April 2, and enrollment was expanded to SARS-CoV-2 negative controls on April 20. A unified enrollment strategy with a single consent process for pregnant women and newborns was implemented on May 4. SARS-CoV-2 status was determined by viral detection on RT-PCR of a nasopharyngeal swab. Wide-ranging and pregnancy-specific samples were collected from maternal participants during pregnancy and postpartum. Newborn samples were collected during the initial hospitalization.

Results: Between April 2 and June 9, 100 women and 78 newborns were enrolled in the MGH COVID-19 biorepository. The rate of dyad enrollment and number of samples collected per woman significantly increased after changes to enrollment strategy (from 5 to over 8 dyads/week, P < 0.0001, and from 7 to 9 samples, P < 0.01). The number of samples collected per woman was higher in SARS-CoV-2 negative than positive women (9 vs 7 samples, P = 0.0007). The highest sample yield was for placenta (96%), umbilical cord blood (93%), urine (99%), and maternal blood (91%). The lowest-yield sample types were maternal stool (30%) and breastmilk (22%). Of the 61 delivered women who also enrolled their newborns, fewer women agreed to neonatal blood compared to cord blood (39 vs 58, P < 0.0001).

Conclusions: Establishing a COVID-19 perinatal biorepository required patient advocacy, transdisciplinary collaboration and creative solutions to unique challenges. This biorepository is unique in its comprehensive sample collection and the inclusion of a control population. It serves as an important resource for research into the impact of COVID-19 on pregnant women and newborns and provides lessons for future biorepository efforts.
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http://dx.doi.org/10.1186/s12874-020-01102-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447612PMC
August 2020

Reaching women with obesity to support weight loss before pregnancy: feasibility and qualitative assessment.

Ther Adv Reprod Health 2020 Jan-Dec;14:2633494120909106. Epub 2020 May 13.

Department of Population Medicine, Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA 02215, USA.

Background: We sought to assess attitudes toward weight and barriers to recruitment of women with obesity for a potential preconception weight-loss/lifestyle modification intervention.

Methods: We performed a qualitative study involving women of reproductive age (18-45) with obesity (body mass index ⩾30 kg/m) who were considering a pregnancy in the next 2 years. We evaluated four methods of recruitment. We used previously validated survey questions to evaluate risk perceptions. In a subset, we used semistructured interviews for topics that required more in-depth information: domains included attitudes toward weight-related issues, intentions, and barriers to engagement in a structured weight-loss program. We performed qualitative analyses of interview transcripts using immersion crystallization.

Results: We recruited the majority (80/82, 98%) of women using e-recruitment strategies. Eighty-one women filled out the survey and 39 completed an interview. Three-quarters of the women surveyed (60 of 81) reported attempts to lose weight in the past year and 77% (68/81) of survey respondents cited jobs and work schedules as a barrier to adopting healthy habits. More than 87% (34 of 39) of women interviewed reported willingness to participate in a structured weight-loss program prior to getting pregnant. Of these, 74% (25 of 34) stated they would consider delaying their attempts at a future pregnancy in order to participate in such a program.

Conclusions: E-recruitment is a promising strategy for recruitment for preconception weight-loss and lifestyle modification program. Most women state a willingness to delay pregnancy attempts to participate in a weight-loss program.
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http://dx.doi.org/10.1177/2633494120909106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7254592PMC
May 2020

Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.

JAMA 2020 06;323(21):2151-2159

Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.

Importance: Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates.

Objective: To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality.

Design, Setting, And Participants: Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019.

Interventions: Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743).

Main Outcomes And Measures: The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality.

Results: Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important).

Conclusions And Relevance: Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.
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http://dx.doi.org/10.1001/jama.2020.5952DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267848PMC
June 2020

Risk factors for developing posttraumatic stress disorder following childbirth.

Psychiatry Res 2020 08 22;290:113090. Epub 2020 May 22.

Department of Psychiatry, Massachusetts General Hospital, Boston, MA; Department of Psychiatry, Harvard Medical School, Boston, MA. Electronic address:

Women can develop childbirth-related posttraumatic stress disorder (CB-PTSD) in at-term delivery with healthy baby outcome as well as following pre-term delivery and neonatal complications, a potential added stressor. No study compares risk factors of CB-PTSD associated with different infant outcomes. We investigated CB-PTSD risk factors by comparing women with or without neonatal complications. Analysis reveals the importance of antepartum and birth-related risk factors in CB-PTSD above and beyond child outcomes, suggesting childbirth is an independent stressor capable of evoking CB-PTSD.
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http://dx.doi.org/10.1016/j.psychres.2020.113090DOI Listing
August 2020

Vanishing Twins Conceived Through Fresh In Vitro Fertilization: Obstetric Outcomes and Placental Pathology.

Obstet Gynecol 2020 06;135(6):1426-1433

Massachusetts General Hospital Fertility Center and Harvard Medical School, Boston, Massachusetts; the Department of Women's Health, Wright Patterson Air Force Base, Wright Patterson AFB, and the Department of Obstetrics & Gynecology, Boonshoft School of Medicine, Wright State University, Dayton, Ohio; the Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts; CellNetix Pathology and Laboratories and Swedish Medical Center, Seattle, Washington; and the Deborah Kelly Center for Outcomes Research, the Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, and the Department of Obstetrics & Gynecology, Massachusetts General Hospital, Boston, Reproductive Endocrinology/Infertility, Department of Obstetrics & Gynecology, UMass Memorial Medical Center, Worcester, Boston IVF, Waltham, and the Department of Obstetrics & Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Objective: To characterize the obstetric outcomes and placental pathology in live births arising from vanishing twin pregnancies compared with nonreduced in vitro fertilization (IVF) pregnancies.

Methods: This is a retrospective cohort study of live births resulting from fresh embryo transfers after IVF cycles with autologous oocytes from 2004 through 2017 at a large academic fertility center. Clinical information and pathology reports were reviewed. Placental diagnoses were coded using established nosology by expert placental pathologists. Analysis of variance, Kruskal-Wallis, Pearson's χ, and Fisher exact tests were used, as appropriate, to compare pathology categories between pregnancy outcomes. Mixed effects logistic regression models were generated to reveal the association between pregnancy outcome and placenta pathology, controlling for pregnancies arising in the same woman and various suspected confounders.

Results: Of 905 fresh autologous IVF cycles with placental pathology available for review, we identified 73 vanishing twin pregnancies (8.1%), 556 singleton pregnancies (61.4%), and 276 twin pregnancies (30.5%). Vanishing twin syndrome was not associated with preterm delivery, route of delivery, growth restriction or other obstetric outcomes as compared with IVF singleton pregnancies. However, vanishing twin syndrome pregnancies showed distinctive placental pathologies including an increased rate of small placentas (less than the 10th percentile by weight), with more anatomical abnormalities than IVF singleton pregnancies (odds ratio 1.73, 95% CI 0.94-3.19; adjusted odds ratio 2.15, 95% CI 1.08-4.28). The frequency of placental vascular and inflammatory pathologies associated with IVF vanishing twin syndrome pregnancies were similar to that of IVF singleton pregnancies. Loss of a twin after 8 weeks of gestation was not associated with greater risks of placental pathologies.

Conclusion: In vitro fertilization pregnancies affected by vanishing twin syndrome did not have significant differences in obstetric or perinatal outcomes as compared with twin or singleton gestations. However, early twin loss was potentially associated with differences in placental development associated with a higher rate of small placentas and other anatomic pathologies.
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http://dx.doi.org/10.1097/AOG.0000000000003888DOI Listing
June 2020

Patient and Hospital Factors Associated With Unexpected Newborn Complications Among Term Neonates in US Hospitals.

JAMA Netw Open 2020 02 5;3(2):e1919498. Epub 2020 Feb 5.

Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.

Importance: Unexpected complications in term newborns have been recently adopted by the Joint Commission as a marker of obstetric care quality.

Objective: To understand the variation and patient and hospital factors associated with severe unexpected complications in term neonates among hospitals in the United States.

Design, Setting, And Participants: This cross-sectional study collected data from all births in US counties with 1 obstetric hospital using county-identified birth certificate data and American Hospital Association annual survey data from January 1, 2015, through December 31, 2017. All live-born, term, singleton infants weighing at least 2500 g were included. The data analysis was performed from December 1, 2018, through June 30, 2019.

Exposures: Severe unexpected newborn complication, defined as neonatal death, 5-minute Apgar score of 3 or less, seizure, use of assisted ventilation for at least 6 hours, or transfer to another facility.

Main Outcomes And Measures: Between-hospital variation and patient and hospital factors associated with unexpected newborn complications.

Results: A total of 1 754 852 births from 576 hospitals were included in the analysis. A wide range of hospital complication rates was found (range, 0.6-89.9 per 1000 births; median, 15.3 per 1000 births [interquartile range, 9.6-22.0 per 1000 births]). Hospitals with high newborn complication rates were more likely to care for younger, white, less educated, and publicly insured women with more medical comorbidities compared with hospitals with low complication rates. In the adjusted models, there was little effect of case mix to explain the observed between-county variation (11.3%; 95% CI, 10.0%-12.6%). Neonatal transfer was the primary factor associated with complication rates, especially among hospitals with the highest rates (66.0% of all complications). The risk for unexpected neonatal complication increased by more than 50% for those neonates born at hospitals without a neonatal intensive care unit compared with those with a neonatal intensive care unit (adjusted odds ratio, 1.55; 95% CI, 1.38-1.75).

Conclusions And Relevance: In this study, severe unexpected complication rates among term newborns varied widely. When included in the metric numerator, neonatal transfer was the primary factor associated with complications, especially among hospitals with the highest rates. Transfers were more likely to be necessary when infants were born in hospitals with lower levels of neonatal care. Thus, if this metric is to be used in its current form, it would appear that accreditors, regulatory bodies, and payers should consider adjusting for or stratifying by a hospital's level of neonatal care to avoid disincentivizing against appropriate transfers.
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http://dx.doi.org/10.1001/jamanetworkopen.2019.19498DOI Listing
February 2020

INI1 negative sarcoma diagnosed as malignant rhabdoid tumor presenting as hydrops fetalis metastatic to the placenta: a case report and review of the literature on congenital sarcomas.

J Matern Fetal Neonatal Med 2019 Nov 12:1-4. Epub 2019 Nov 12.

Pathology Service, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

Rhabdoid tumor is a highly aggressive sarcoma found in young children that occurs in the kidney, central nervous system and soft tissue sites. Rarely, it presents in the fetus or neonate and is associated with a dismal prognosis. We report a case of a 28-week gestation fetus presenting with hydrops fetalis who died soon after delivery, found at autopsy to have a rhabdoid tumor of the thoracic cavity with placental metastases and provide a review of the literature of congenital sarcomas.
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http://dx.doi.org/10.1080/14767058.2019.1688782DOI Listing
November 2019

Hospital bans on trial of labor after cesarean and antepartum transfer of care.

Birth 2019 12 5;46(4):574-582. Epub 2019 Nov 5.

Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, California.

Background: Hospital policies restricting access to trial of labor after cesarean (TOLAC) are prevalent. Many women with a previous cesarean birth are affected by these bans, but there are limited data on the effect of these bans and whether women would consider changing delivery hospitals in the setting of a real or hypothetical TOLAC ban.

Methods: This was a survey of TOLAC-eligible women receiving prenatal care at four hospitals where TOLAC is available, and 1 non-TOLAC site. Participants were asked about their likelihood of switching hospitals to pursue TOLAC if it were unavailable. Women at the non-TOLAC site had their medical records reviewed to ascertain final location and approach to delivery.

Results: A total of 297 women were interviewed, 48 from the non-TOLAC site. 162 (54%) participants indicated they would transfer care if TOLAC were unavailable. Among women at the non-TOLAC site, 57% who indicated an intention to switch hospitals did so. In a multivariable logistic regression model, variables associated with transferring care included race/ethnicity other than Latina (aOR 25.20 [95% CI 2.23-284.26]), being unaware of the TOLAC ban (19.81 [1.99-196.64]), and perceiving that a close friend/relative thought they should undergo TOLAC (17.31 [1.70-176.06]).

Conclusions: More than half of women with prior cesarean would consider transferring care if TOLAC became unavailable, and more than 1 of 3 of women at a non-TOLAC site transferred care. More research is needed on the impact of TOLAC bans and how to facilitate transfer for those who desire TOLAC.
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http://dx.doi.org/10.1111/birt.12460DOI Listing
December 2019

Correction to: The association of patient preferences and attitudes with trial of labor after cesarean.

J Perinatol 2019 Dec;39(12):1696

Departments of Obstetrics, Gynecology & Reproductive Sciences and Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1038/s41372-019-0522-7DOI Listing
December 2019

Association of Medicaid Expansion With Coverage and Access to Care for Pregnant Women.

Obstet Gynecol 2019 11;134(5):1066-1074

Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, the Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, and the Department of Medicine, Brigham & Women's Hospital, Boston, Massachusetts; and the Department of Health Policy & Management, Columbia University Mailman School of Public Health, New York, New York.

Objective: To identify the association of the Affordable Care Act's Medicaid expansion with payment for delivery, early access to prenatal care, preterm birth, and birth weights considered small for gestational age (SGA).

Methods: A difference-in-difference design was used to assess changes in outcomes before and after Medicaid expansion in expansion states, using nonexpansion states as a control group. We used national birth certificate data from 2009 to 2017. Difference-in-difference linear probability models were used to assess the effects of the policy implementation, adjusting for demographics, month of birth, state, year, and county-level unemployment rates. Standard errors were clustered at the state level. Two prespecified subgroup analyses were performed of nulliparous women and women with no more than a high school diploma.

Results: The study sample included 8,701,889 women from 15 expansion states and 9,509,994 from 11 nonexpansion states. In the adjusted analysis, the percentage of Medicaid-covered deliveries increased by 2.3 absolute percentage points (95% CI 0.2-4.4, P=.04) in expansion states compared with nonexpansion states. There were no significant changes in the proportion of women who were uninsured, as there was a relative decrease in the percentage of deliveries covered by private insurance (-2.8 percentage points [95% CI -4.9 to -0.8, P=.01]). There were also no significant differences in the rate of women initiating prenatal care in the first trimester, preterm birth rates, or rates of low birth weight after the Medicaid expansion. Findings were similar in both subgroups.

Conclusion: Medicaid expansion was associated with increased Medicaid coverage for childbirth in expansion states; similar gains in private coverage were seen in nonexpansion states. There were no associations with changes in early access to prenatal care, preterm birth, or SGA birth weights.
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http://dx.doi.org/10.1097/AOG.0000000000003501DOI Listing
November 2019

Placental pathology in live births conceived with in vitro fertilization after fresh and frozen embryo transfer.

Am J Obstet Gynecol 2020 04 4;222(4):360.e1-360.e16. Epub 2019 Oct 4.

Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Background: The availability and use of frozen embryos after ovarian hyperstimulation for assisted reproduction has increased with improvement in vitrification techniques and the rise of preimplantation genetic testing. However, there are conflicting data regarding whether obstetric outcomes differ between fresh and frozen embryo transfer cycles.

Objective: To compare placental pathology from live births arising from fresh and frozen embryo transfer cycles.

Materials And Methods: A cohort of 1140 live births with placental pathology arising from autologous in vitro fertilization cycles with fresh or frozen programmed transfer performed at MGH Fertility Center between 2004 and 2017 was retrospectively reviewed. An experienced placental pathologist categorized the reported placental pathology as anatomic, infectious, inflammatory, or vascular/thrombotic. Our primary outcomes were differences in these placental pathologies between the 2 groups. Patient demographic, cycle, and birth outcomes were compared with the use of χ tests, Student t test, or nonparametric tests, as appropriate. Multivariate logistic regression models were used to compare placental pathology between the fresh and frozen transfer groups.

Results: Of the 1140 cycles included in our analysis, 929 arose from fresh embryo transfers (81.3%) and 211 arose from programmed frozen embryo transfers (18.5%). For both transfer types, the average age of the women at time of treatment was 35 years; mean body mass indices were within the normal range (23.6 kg/m for fresh transfers and 23.2 kg/m for frozen transfers, P = .26), and mean day 3 follicle-stimulating hormone values were 7.1 and 7.0 IU/L (P = .44), respectively. Deliveries occurred on average at 37.5 and 38.0 weeks' gestational age (P = .04) in the fresh versus frozen transfer group, with similar rates of obstetric complications. However, frozen transfers were more likely to be associated with marginal cord insertion (adjusted odds ratio, 1.87; confidence interval, 1.21, 2.91; P = .01), accessory lobe formation (adjusted odds ratio, 2.96; confidence interval, 1.12, 7.79; P = 0.03), subchorionic thrombi (adjusted odds ratio, 3.72; confidence interval, 1.80, 7.71; P < .001), and fetal vascular malperfusion characteristics with cord anomalies (adjusted odds ratio, 2.34; confidence interval, 1.22, 4.46; P = .01). These trends persisted when we analyzed day 5 transfers alone, and single frozen embryo transfers remained associated with increased rates of subchorionic thrombi compared to single fresh embryo transfers.

Conclusion: Pregnancies arising from frozen embryo transfers demonstrated more anatomic and vascular placental pathology than those from fresh transfers in our cohort of patients, despite similar maternal outcomes. More research is needed to explore how these differences in pathology may influence obstetric and perinatal outcomes.
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http://dx.doi.org/10.1016/j.ajog.2019.09.047DOI Listing
April 2020