Publications by authors named "Gabriele Saccone"

219 Publications

Prenatal diagnosis and postnatal management of congenital unilateral hydrocephalus for stenosis of the foramen of Monro.

Radiol Case Rep 2021 Sep 3;16(9):2530-2533. Epub 2021 Jul 3.

Department of Neurosurgery, Santobono-Pausilipon Children's Hospital, Naples, Italy.

Congenital hydrocephalus and ventriculomegaly can be diagnosed reliably with prenatal ultrasound and Magnetic Resonance Imaging (MRI). Unilateral hydrocephalus is uncommon, and the prognosis depends on etiology and postnatal management. Here, we present a case of a 32-years-old woman with prenatal diagnosis of unilateral hydrocephalus associated with stenosis of the foramen of Monro. Unilateral hydrocephalus is an uncommon feature that can be detected prenatally on ultrasound and MRI. In case of isolated stenosis of the foramen of Monro prognosis is good.
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http://dx.doi.org/10.1016/j.radcr.2021.06.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8260955PMC
September 2021

Reply to Delayed versus immediate pushing in the second stage of labor in women with neuraxial analgesia: a systematic review and meta-analysis of randomized controlled trials.

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

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, 834 Chestnut St., Philadelphia, PA 19107. Electronic address:

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http://dx.doi.org/10.1016/j.ajog.2021.06.073DOI Listing
June 2021

Computerized cardiotocography in singleton gestations with diabetes mellitus: a retrospective study.

Minerva Obstet Gynecol 2021 Jun 7. Epub 2021 Jun 7.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

Objective: To evaluate the use of computerized cardiotocography (C-CTG) in women with diabetes mellitus.

Methods: This was a retrospective cohort study of women with diabetes mellitus referred to University of Naples Federico II from January 2018 to January 2020 for antenatal monitoring. Only women who underwent antenatal monitoring with C-CTG were included in the study. For the purpose of this study only the C-CTG recorded at the time of outpatient admission were analysed. Women were divided into four groups: 1. Women with diabetes mellitus type 1; 2. Women with diabetes mellitus type 2; 3. Women with gestational diabetes mellitus (GDM); 4. Control group without diabetes mellitus. The primary outcome of the study was the C-CTG short term variability (STV).

Results: A total of 298 patients were included in the study, 89 with type 1 diabetes (group 1), 27 with type 2 diabetes (group 2), 77 with GDM (group 3) and 105 controls (group 4). Fetal heart rate was statistically higher in pregnant women with pre-pregnancy diabetes both Type 1 and 2 compared to gestational diabetes and physiological pregnancies. The parameters of STV, APRS and DPRS were statistically lower in the pregnant group with pre-pregnancy type 1 diabetes than in type 2 and compared to group 3 and 4.

Conclusions: Fetal heart rate was statistically higher in pregnant women with pre-pregnancy diabetes, both Type 1 and 2, compared to gestational diabetes and controls. STV, APRS and DPRS were statistically lower in the pregnant group with pre-pregnancy type 1 diabetes than in type 2 and compared to group 3 and 4.
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http://dx.doi.org/10.23736/S2724-606X.21.04786-2DOI Listing
June 2021

The efficacy of abdominal binders in reducing postoperative pain and distress after cesarean delivery: A meta-analysis of randomized controlled trials.

Eur J Obstet Gynecol Reprod Biol 2021 Jul 9;262:73-79. Epub 2021 May 9.

Department of Maternal and Child Health and Urological Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.

Objective: To evaluate the efficacy of abdominal binders in reducing postoperative pain, patient distress and surgical postoperative sequelae after cesarean delivery (CD).

Methods: A comprehensive search in electronic databases (MEDLINE, EMBASE, and Cochrane Central) was performed up to February 2021. Selection criteria included randomized clinical trials investigating the application or not of abdominal binder after CD. The primary outcome was postoperative pain, measured using the visual analog scale (VAS) pain score. Secondary outcomes were divided into short- and long-term postoperative outcomes, including patient distress, need for additional pain medications, time to mobilization, return to normal daily activities, surgical site infection, fascial dehiscence or incisional hernia, and rectus abdominis diastasis. The summary measures were reported as mean difference with 95 % confidence intervals (CI) using the random effects model of DerSimonian and Laird. An I (Higgins I) value of greater than 0% was used to identify heterogeneity.

Results: Four RCTs involving 601 women were included for meta-analysis: 310 (51.6 %) were randomized to the abdominal binder and 291 (48.4 %) to no abdominal binder group. There was no statistically significant difference between the two groups for VAS score either at 24 h (MD -0.97, 95 % CI -2.23 to 0.30; p = 0.13) and at 48 h (MD -0.30, 95 % CI -0.71 to 0.11; p = 0.15). Conversely, there was a significant reduction in postoperative distress (SDS) both at 24 h (MD -2.23, 95 % CI -3.77 to -0.70; p = 0.004) and 48 h (MD -2.37, 95 % CI -3.86 to -0.87; p = 0.002).

Conclusion: The present meta-analysis shows that the use of abdominal binders after CD significantly reduces patient distress.
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http://dx.doi.org/10.1016/j.ejogrb.2021.05.014DOI Listing
July 2021

Role of progesterone, cerclage and pessary in preventing preterm birth in twin pregnancies: A systematic review and network meta-analysis.

Eur J Obstet Gynecol Reprod Biol 2021 Jun 24;261:166-177. Epub 2021 Apr 24.

Fetal Medicine Unit, Saint George's University of London, London, United Kingdom; Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, United Kingdom.

Objective: To determine the role of progesterone, pessary and cervical cerclage in reducing the risk of (preterm birth) PTB in twin pregnancies and compare these interventions using pairwise and network meta-analysis.

Study Design: Medline, Embase, CINAHL and Cochrane databases were explored. The inclusion criteria were studies in which twin pregnancies were randomized to an intervention for the prevention of PTB (any type of progesterone, cervical cerclage, cervical pessary, or any combination of these) or to a control group (e.g. placebo or treatment as usual). Interventions of interest were either progesterone [vaginal or oral natural progesterone or intramuscular 17a-hydroxyprogesterone caproate (17-OHPC)], cerclage (McDonald or Shirodkar), or cervical pessary. The primary outcome was PTB < 34 weeks of gestation. Both primary and secondary outcomes were explored in an unselected population of twin pregnancies and in women at higher risk of PTB (defined as those with cervical length <25 mm). Random-effect head-to-head and a multiple-treatment meta-analyses were used to analyze the data and results expressed as risk ratios.

Results: 26 studies were included in the meta-analysis. When considering an unselected population of twin pregnancies, vaginal progesterone, intra-muscular17-OHPC or pessary did not reduce the risk of PTB < 34 weeks of gestation (all p > 0.05). When stratifying the analysis for spontaneous PTB, neither pessary, vaginal or intramuscular 17-OHPC were associated with a significant reduction in the risk of PTB compared to controls (all p > 0.05), while there was no study on cerclage which explored this outcome in an unselected population of twin pregnancies. When considering twin pregnancies with short cervical length (≤25 mm), there was no contribution of either pessary, vaginal progesterone, intra-muscular 17-OHPC or cerclage in reducing the risk of overall PTB < 34 weeks of gestation.

Conclusions: Cervical pessary, progesterone and cerclage do not show a significant effect in reducing the rate of PTB or perinatal morbidity in twins, either when these interventions are applied to an unselected population of twins or in pregnancies with a short cervix.
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http://dx.doi.org/10.1016/j.ejogrb.2021.04.023DOI Listing
June 2021

Pregnant women's perspectives on severe acute respiratory syndrome coronavirus 2 vaccine.

Am J Obstet Gynecol MFM 2021 Mar 23;3(4):100352. Epub 2021 Mar 23.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Carbone, Sirico, Di Girolamo, Saccone, Donadono, Cuomo, Gabrielli, Migliorini, and Prof Maruotti).

Background: Since coronavirus disease 2019 vaccines have been distributed, a debate has raised on whether pregnant women should get the vaccine. No available data exist so far regarding the safety, efficacy, and toxicology of these vaccines when administered during pregnancy. Most of the Obstetrics and Gynecology societies suggested that pregnant could agree to be vaccinated, after a thorough counseling of risks and benefits with their gynecologists, thus leading to an autonomous decision.

Objective: This study aimed to evaluate the attitude to coronavirus disease 2019 vaccination in pregnant and breastfeeding women in Italy.

Study Design: A survey was made at the University of Naples Federico II and the Ospedale Cristo Re, Tor Vergata University of Rome, on pregnant and breastfeeding women asking their perspectives on the available vaccines after reading the recommendations issued by our national Obstetrics, Gynecology, and Neonatology societies. The questionnaire included 12 items finalized to evaluate general features of the women and 6 items specifically correlated to their attitudes toward the severe acute respiratory syndrome coronavirus 2 vaccination. Chi-square or Fisher's exact tests were used to compare group differences of categorical variables and Wilcoxon signed rank or Mann-Whitney U test for continuous variables. The study was approved by the institutional review boards of the University of Naples Federico II (ref. no. 409/2020) and the Ospedale Cristo Re, Tor Vergata University of Rome (ref. #Ost4-2020).

Results: Most of the included women did not agree to eventually receive severe acute respiratory syndrome coronavirus 2 vaccine during pregnancy (40 [28.2%] vs 102 [71.8%]). Being pregnant was considered a determinant factor to refuse the vaccine prophylaxis (99 [69.7%] vs 43 [30.3%]; chi-square test=24.187; P<.001), even if a very large percentage declared to be generally in favor of vaccines (128 [90.1%] vs 14 [9.9%]; chi-square test=6.091; P=.014) and most of them confirmed they received or would receive other recommended vaccines during pregnancy (75 [52.8%] vs 67 [47.2%]; chi-square test=10.996; P=.001).

Conclusion: Urgent data are needed on the safety, efficacy, and toxicology of severe acute respiratory syndrome coronavirus 2 vaccines during pregnancy to modify this trend and to help obstetricians during the counseling. Furthermore, pregnant women should be included in future vaccine development trials to not incur again in such uncertainty.
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http://dx.doi.org/10.1016/j.ajogmf.2021.100352DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985679PMC
March 2021

Maternal and perinatal outcomes in high compared to low risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection (phase 2): the World Association of Perinatal Medicine working group on coronavirus disease 2019.

Am J Obstet Gynecol MFM 2021 02 20;3(4):100329. Epub 2021 Feb 20.

Department of Obstetrics and Gynecology, Centre for High-Risk Pregnancy and Fetal Care, University of Chieti, Chieti, Italy (Dr Liberati, Dr Sebastiano, Dr Oronzi, Dr Cerra, and Dr Buca).

Background: It has still to be ascertained whether severe acute respiratory syndrome coronavirus 2 infection in pregnancy is associated with worse maternal and fetal outcomes compared to low risk gestations.

Objective: This study aimed to evaluate maternal and perinatal outcomes in high- and low-risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection.

Study Design: This was a multinational retrospective cohort study involving women with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection from 76 centers from 25 countries in Europe, the United States, South America, Asia, and Australia from April 4, 2020, to October 28, 2020. The primary outcome was a composite measure of maternal mortality and morbidity, including admission to the intensive care unit, use of mechanical ventilation, or death. The secondary outcome was a composite measure of adverse perinatal outcome, including miscarriage, fetal loss, neonatal and perinatal death, and admission to the neonatal intensive care unit. All outcomes were assessed in high- and low-risk pregnancies. Pregnancies were considered high risk in case of either preexisting chronic medical conditions in pregnancy or obstetrical disorders occurring in pregnancy. The Fisher exact test and logistic regression analysis were used to analyze the data.

Results: A total of 887 singleton pregnancies who tested positive for severe acute respiratory syndrome coronavirus 2 infection using reverse transcription-polymerase chain reaction of nasal and pharyngeal swab specimens were included in the study. The risk of composite adverse maternal outcomes was higher in high-risk pregnancies than in low-risk pregnancies (odds ratio, 1.52; 95% confidence interval, 1.03-2.24; P=.035). In addition, women carrying high-risk pregnancies were at higher risk of hospital admission (odds ratio, 1.48; 95% confidence interval, 1.07-2.04; P=.002), presence of severe respiratory symptoms (odds ratio, 2.13; 95% confidence interval, 0.41-3.21; P=.001), admission to the intensive care unit (odds ratio, 2.63; 95% confidence interval, 1.42-4.88), and invasive mechanical ventilation (odds ratio, 2.65; 95% confidence interval, 1.19-5.94; P=.002). When exploring perinatal outcomes, high-risk pregnancies were at high risk of adverse perinatal outcomes (odds ratio, 1.78; 95% confidence interval, 0.15-2.72; P=.009). However, such association was mainly because of the higher incidence of miscarriage in high-risk pregnancies compared with that in low-risk pregnancies (5.3% vs 1.6%, P=.008); furthermore, there was no difference in other explored outcomes between the 2 study groups. At logistic regression analysis, maternal age (odds ratio, 1.12; 95% confidence interval, 1.02-1.22; P=.023) and high-risk pregnancy (odds ratio, 4.21; 95% confidence interval, 3.90-5.11; P<.001) were independently associated with adverse maternal outcomes.

Conclusion: High-risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection were at higher risk of adverse maternal outcomes than low-risk pregnancies complicated by severe acute respiratory syndrome coronavirus 2 infection.
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http://dx.doi.org/10.1016/j.ajogmf.2021.100329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7896113PMC
February 2021

Coronavirus disease 2019 vaccine in pregnant women: not so far! The importance of counseling and the need for evidence-based data.

Am J Obstet Gynecol MFM 2021 05 1;3(3):100324. Epub 2021 Feb 1.

Department of Maternal and Child Health and Urological Sciences, Sapienza University of Rome, Rome, Italy.

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http://dx.doi.org/10.1016/j.ajogmf.2021.100324DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129723PMC
May 2021

Risk of unscheduled delivery in women with placenta accreta according to planned gestational age at delivery.

J Matern Fetal Neonatal Med 2021 Jan 27:1-4. Epub 2021 Jan 27.

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA.

Background: The optimal gestational age at delivery for stable women with suspected placenta accreta is still subject of debate.

Objective: To estimate the likelihood of vaginal bleeding necessitating expedited delivery in women with placenta accreta according to gestational age at planned cesarean hysterectomy.

Study Design: This was a multicenter cohort study. Singleton pregnancies at risk of placenta accreta because of placenta previa in the setting of prior cesarean delivery were included. Outcomes were compared in cohort of women who had planned cesarean hysterectomy at 34 0/7 - 34 6/7 weeks versus at 35 0/7 - 35 6/7 weeks. The primary outcome was incidence of vaginal bleeding severe enough to necessitate delivery.

Results: 118 singleton pregnancies with placenta previa in the setting of prior cesarean delivery, and confirmed placenta accreta at the time of delivery were included in the study. Women who had planned cesarean hysterectomy at 34 weeks had lower episodes of vaginal bleeding severe enough to necessitate immediate or emergency delivery (20.6% vs 38.0%; odds ratio (OR) 0.42, 95% confidence interval (CI) 0.19 to 0.96). Eight women (11.8%) in the 34 weeks group and 6 women (12.0%) in the 35 weeks group delivered before the planned date due to onset of spontaneous labor (OR 0.98, 95% CI 0.32 to 3.02).

Conclusion: In singleton gestations with suspected placenta accreta, planned cesarean hysterectomy at 34 0/7 - 34 6/7 weeks was associated with a decreased chance of unscheduled delivery due to severe vaginal bleeding.

Condensation: In case of placenta accreta, planned cesarean hysterectomy at 34 weeks was associated with decreased chance of unscheduled delivery due to severe vaginal bleeding.
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http://dx.doi.org/10.1080/14767058.2021.1878493DOI Listing
January 2021

Birthing ball for reducing labor pain: a systematic review and meta-analysis of randomized controlled trials.

J Matern Fetal Neonatal Med 2021 Jan 21:1-10. Epub 2021 Jan 21.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA.

Objective: Multiple factors are thought to affect a woman's sensation of pain during the process of labor. Birthing balls are round exercise balls upon which a woman sits during labor and performs different movements such as rocking back and forth and pelvic rotation. Midwives and nurses have been using birthing balls (also known as Swiss balls) to increase maternal comfort, widen the pelvic outlet, and facilitate progression of labor for women laboring without an epidural. Therefore, the aim of this systematic review and meta-analysis of randomized controlled trials is to assess whether the use of the birthing ball in labor decreases maternal pain during labor.

Data Sources: Research was conducted using PubMed, Scopus, ClinicalTrial.gov, OVID and Cochrane Library as electronic databases. Randomized controlled trials were identified using the following search strategy: "birthing ball" OR "birth ball" OR "swiss ball" OR "exercise ball" AND labor from the inception of each database to June 2019. No restrictions for language or geographic location were applied.

Study Eligibility Criteria: Selection criteria included randomized trials of pregnant women with a singleton, cephalic fetus who were randomized to either birthing ball or control group (i.e. no birthing ball) for use in labor.

Study Appraisal And Synthesis Methods: Seven trials with 533 pregnant women were included. 287 (53.8%) were randomized to the intervention group (birthing ball) and 246 (46.2%) were randomized to the control group (no birthing ball). All analyses were done using an intention-to-treat approach, evaluating women according to the treatment group to which they were randomly allocated in the original trials. The primary outcome was labor pain in the first stage of labor. The summary measures were reported as summary relative risk (RR) or as summary mean difference (MD) with 95% of confidence interval (CI) using the random-effects model of DerSimonian and Laird.

Results: Labor pain significantly decreased by 1.70 points in the birthing ball group compared to the control group (MD -1.70 points; 95% CI -2.20 to -1.20). Use of the birthing ball versus no birthing ball did not result in a significant difference in incidence of spontaneous vaginal delivery, operative vaginal delivery, cesarean delivery, or perineal lacerations.

Conclusion: The birthing ball is an effective method of pain reduction during labor for women laboring without an epidural.
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http://dx.doi.org/10.1080/14767058.2021.1875439DOI Listing
January 2021

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

J Perinat Med 2020 Dec 2;49(1):111-115. Epub 2020 Dec 2.

Department of Obstetrics and Gynaecology, Fetal Medicine Unit, Maternal and Child Health and Development Network, University Hospital 12 de Octubre, Complutense University of Madrid, Madrid, Spain.

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http://dx.doi.org/10.1515/jpm-2020-0539DOI Listing
December 2020

Antenatal cardiotocography with and without computer analysis in high-risk pregnancy: a randomized clinical trial.

Am J Obstet Gynecol MFM 2021 01 27;3(1):100284. Epub 2020 Nov 27.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

Background: Cardiotocography or nonstress test is a technical means of recording the fetal heartbeat and uterine contractions for antenatal monitoring.

Objective: This study aimed to evaluate whether antepartum cardiotocography with computer analysis (computerized cardiotocography) increases the incidence of cesarean delivery in women with high-risk pregnancies but without intrauterine growth restriction.

Study Design: This was a parallel group nonblinded randomized clinical trial of singletons with high-risk pregnancies admitted for inpatient monitoring between 24 0/7 and 37 6/7 weeks' gestation. Eligible participants were randomly allocated in a 1:1 ratio to antenatal monitoring with either standard cardiotocography or computerized cardiotocography. Women randomized to the computerized cardiotocography arm received cardiotocographic monitoring with computerized analysis in a central monitoring station. The primary outcome was the incidence of cesarean delivery.

Results: Overall, 28 women were enrolled in this trial. In addition, 14 women were randomized to the computerized cardiotocography group and 14 women to the control group. No woman was excluded after randomization or lost to follow-up. Cesarean delivery occurred in 9 women (64.3%) in the computerized cardiotocography group and 9 women (64.3%) in the control group (relative risk, 1.00; 95% confidence interval, 0.21-4.69).There was no significant between-group difference in preterm birth, gestational age at delivery, Apgar score, and birthweight.

Conclusion: Among women with high-risk pregnancies, use of computerized cardiotocography for antenatal monitoring did not result in a significant increase in cesarean delivery compared with standard cardiotocography. The results of this single-center randomized trial require confirmation in multicenter studies.
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http://dx.doi.org/10.1016/j.ajogmf.2020.100284DOI Listing
January 2021

Psychopathology associated with coronavirus disease 2019 among pregnant women.

Am J Obstet Gynecol MFM 2021 01 4;3(1):100290. Epub 2020 Dec 4.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, 833 Chestnut, Philadelphia, PA 19107. Electronic address:

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http://dx.doi.org/10.1016/j.ajogmf.2020.100290DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833641PMC
January 2021

Oral supplementation with arginine, willow bark, magnesium and calcium in prevention of preterm birth.

J Obstet Gynaecol 2021 May 11;41(4):673. Epub 2021 Jan 11.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

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http://dx.doi.org/10.1080/01443615.2020.1825355DOI Listing
May 2021

Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial.

Am J Obstet Gynecol MFM 2021 03 7;3(2):100307. Epub 2021 Jan 7.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

Background: Cervical pessary has been proven to be effective in reducing the rate of preterm birth in asymptomatic women with singleton gestations and short cervical length in the midtrimester of pregnancy; however, the efficacy of this device in women with arrested preterm labor is still a subject of debate.

Objective: This study aimed to test the hypothesis that the use of a cervical pessary in women with singleton pregnancy and arrested preterm labor would reduce the risk of preterm birth at <37 weeks of gestation.

Study Design: This study is a parallel group, nonblinded, randomized trial. Participants included in the study were women with a diagnosis of arrested preterm labor between 24 0/7 and 33 6/7 weeks of gestations. The participants were randomized to either the cervical pessary group or no pessary group in a 1:1 ratio. The primary endpoint was preterm birth at <37 weeks of gestation. A sample size of 120 participants was determined, but the trial was concluded before the completion of enrollment.

Results: A total of 61 women with singleton pregnancies and arrested preterm labor at 24 0/7 to 33 6/7 weeks of gestation were enrolled in the trial. Of the 61 women, 32 were randomized to the cervical pessary group and 29 to the control group. Preterm birth at <37 weeks of gestation occurred in 14 women (43.8%) in the pessary group and 6 women (20.7%) in the control group (relative risk, 2.98; 95% confidence interval, 0.96-9.30).

Conclusion: In this underpowered trial, among women with singleton pregnancies and arrested preterm labor, compared with no pessary use, the use of a cervical pessary does not result in a lower rate of preterm birth at <37 weeks of gestation.
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http://dx.doi.org/10.1016/j.ajogmf.2021.100307DOI Listing
March 2021

Cesarean delivery: an evidence-based review of the technique.

Minerva Obstet Gynecol 2021 Feb 14;73(1):57-66. Epub 2020 Dec 14.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, PA, USA.

The cesarean section is utilized to deliver babies since the late 19 century. Nowadays, the frequency of cesarean section is increased, mainly because of the low rate of complications and for the increasing demand from future mothers, scared by the idea of painful labor. Although the technique to perform cesarean section has been refined over time, infections, hemorrhage, pain and other consequences still represent matter of debate. To try to reduce the incidence of these complications many trials, randomized or not, have been performed, with the aim to analyze different technical aspects of this surgery. The aim of our review was to resume all the evidence-based instructions on how to best approach to cesarean section practice, in a step-to-step fashion, considering pre-operative actions, opening and closing steps, and postoperative prophylaxis.
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http://dx.doi.org/10.23736/S0026-4784.20.04681-XDOI Listing
February 2021

Adhesion barriers in laparoscopic myomectomy: Evidence from randomized clinical trials.

Int J Gynaecol Obstet 2021 Mar 8;152(3):308-320. Epub 2021 Jan 8.

Gynecology and Human Reproduction Physiopathology, Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), IRCCS S. Orsola Hospital, University of Bologna, Bologna, Italy.

Objective: To evaluate the effectiveness of different adhesion barriers in the prevention of de novo adhesion development after laparoscopic myomectomy.

Methods: A systematic review was performed by searching seven electronic databases for all randomized clinical trials (RCTs) comparing the use of any absorbable adhesion barrier (i.e. intervention group) with either no treatment or placebo (i.e. control group) in the prevention of adhesion development after laparoscopic myomectomy.

Results: Eight RCTs with a total of 748 participants (392 in the intervention group and 356 in the control group) were included. The assessed adhesion barrier methods were: oxidized regenerated cellulose (ORC) in two studies, auto-crosslinked hyaluronic acid (HA) gel in two studies, 4% icodextrin solution in one study, modified HA and carboxy-methylcellulose in one study, polyethylene glycol ester trilysine amine solution plus a borate buffer solution in one study, and polyethylene glycol amine plus dextran aldehyde polymers in another study.

Conclusion: Adhesion barrier methods showing the most promising results were: ORC, auto-crosslinked HA gel, and polyethylene glycol amine plus dextran aldehyde polymers.
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http://dx.doi.org/10.1002/ijgo.13495DOI Listing
March 2021

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

J Perinat Med 2020 11;48(9):950-958

Department of Obstetrics and Gynaecology, Ospedale di San Leonardo, Castellammare di Stabia, Italy.

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6±9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; p<0.001), birthweight (OR: 1.17, 95% CI 1.09-1.12.7 per 100 g decrease; p=0.012) and maternal ventilatory support, including either need for oxygen or CPAP (OR: 4.12, 95% CI 2.3-7.9; p=0.001) were independently associated with composite adverse fetal outcome. Conclusions Early gestational age at infection, maternal ventilatory supports and low birthweight are the main determinants of adverse perinatal outcomes in fetuses with maternal COVID-19 infection. Conversely, the risk of vertical transmission seems negligible.
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http://dx.doi.org/10.1515/jpm-2020-0355DOI Listing
November 2020

Reply.

Am J Obstet Gynecol 2021 01 17;224(1):128-129. Epub 2020 Sep 17.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, 833 Chestnut, Philadelphia, PA 19107. Electronic address:

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http://dx.doi.org/10.1016/j.ajog.2020.09.018DOI Listing
January 2021

Use of Negative Pressure Wound Therapy Systems after Radical Vulvectomy for Advanced Vulvar Cancer.

Cancer Invest 2020 Sep 14;38(8-9):531-534. Epub 2020 Sep 14.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

A retrospective cohort study was performed to evaluate the efficacy of negative pressure wound therapy in improving vulvectomy healing. Women who underwent radical vulvectomy with complete inguinofemoral lymphadenectomy for advanced vulvar cancer were divided into two groups according to immediate postoperative care: patients treated with negative pressure wound therapy using the device applied on the site of the wound (including vulva and inguinal region), and patients receiving conventional care. 18 patients were included in the study. 7 (38.9%) women were treated with negative pressure wound therapy immediately after the surgery and were included in the intervention group, and 11 (61.1%) patients were included in the control group. Women who received negative pressure wound therapy had significantly lower length of stay in the hospital (14.2 ± 4.7 versus 17.1 ± 6.1 days, mean difference -6.90 days, 95% confidence interval -11.91 to -1.89), and significantly lower length for wound healing (-31.90 days, 95% confidence interval -43.48 to -20.32). In conclusion, the utilization of the negative wound pressure therapy may contribute to reduce hospitalization after radical vulvectomy for vulvar cancer. Large and well-designed randomized trials with cost effectiveness analyses are needed to confirm these findings.
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http://dx.doi.org/10.1080/07357907.2020.1817484DOI Listing
September 2020

Being an obstetrics and gynaecology resident during the COVID-19: Impact of the pandemic on the residency training program.

Eur J Obstet Gynecol Reprod Biol 2020 Oct 1;253:48-51. Epub 2020 Aug 1.

Department of Clinical and Experimental Medicine, Unit of Obstetrics and Gynecology, Magna Graecia University of Catanzaro, Catanzaro, Italy.

Objective: to evaluate the impact of the COVID-19 pandemic on the obstetrics and gynecology residency training program in Italy.

Study Design: This was a cross-sectional survey study aimed to assess the impact of the COVID-19 pandemic on the obstetrics and gynecology residency training program in Italy. An online survey with 45 questions was sent and completed anonymously by residents after accepting an informed consent. The invitation to the online survey was sent to all the Italian residents in obstetrics and gynecology. Those on maternity leave at the time of the study were excluded. Residents were asked about their routinely activity before the COVID-19 pandemic, and to report the reduction in their clinical practice. They were also asked about psychological impact of COVID-19 on their clinical practice.

Results: 933 Italian residents in obstetrics and gynecology, were invited for this survey study. Four-hundred and seventy-six (51 %) completed the survey and were included in the study. Three-hundred and eighty-seven (81.3 %) were female, and 89 (18.7 %) were male. Residents age ranged from 25 to 42. In 71,8 % (342/476) of the cases residents work in a COVID-19 reference Hospitals. One-hundred and eighty-four out of 76 residents (38.6 %) were tested on RT-PCR assay of nasal and pharyngeal swab specimens, and of them 12/184 (6.5 %) were positive to SARS-COV-2. Regarding the use of personal protective equipment (PPE), 267 (56.1 %) reported to receive adequate device, and 379 (79.6 %) felt to be well informed about prevention and management protocols. Three-hundred and thirty-one residents (69.5 %) reported to have managed COVID-19 positive patients. For 54,7 % of respondent residents, training activity in general decreased significantly during the COVID-19 epidemic. A one-third reduction was reported in 31,4 % of the cases, whereas a total suspension of the training in 9,9 % of the cases. In 89,3 % of cases the reduction was caused by the reorganization of work. Anxiety about the professional future was reported in 84 % of the residents, and 59 % of them had the perception that their training was irreversibly compromised.

Conclusions: Among Italian residents in obstetrics and gynecology, COVID-19 pandemic was associated with a significant training impairment.
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http://dx.doi.org/10.1016/j.ejogrb.2020.07.057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395645PMC
October 2020

Risk factors associated with bladder injury at the time of cesarean hysterectomy for placenta accreta.

Minerva Ginecol 2020 12 3;72(6):425-426. Epub 2020 Aug 3.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, Federico II University, Naples, Italy.

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http://dx.doi.org/10.23736/S0026-4784.20.04611-0DOI Listing
December 2020

Reply to correspondence: Prenatal diagnosis of central nervous system abnormalities: Neurosonography versus fetal magnetic resonance imaging.

Eur J Obstet Gynecol Reprod Biol 2020 10 21;253:337-338. Epub 2020 Jul 21.

Department of Neuroscience, Reproductive Science and Dentistry, University of Naples Federico II, Naples, Italy.

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http://dx.doi.org/10.1016/j.ejogrb.2020.07.038DOI Listing
October 2020

Clinical management of coronavirus disease 2019 (COVID-19) in pregnancy: recommendations of WAPM-World Association of Perinatal Medicine.

J Perinat Med 2020 Nov;48(9):857-866

Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.

These guidelines follow the mission of the World Association of Perinatal Medicine, which brings together groups and individuals throughout the world with the goal of improving outcomes of maternal, fetal and neonatal (perinatal) patients. Guidelines for auditing, evaluation, and clinical care in perinatal medicine enable physicians diagnose, treat and follow-up of COVID-19-exposed pregnant women. These guidelines are based on quality evidence in the peer review literature as well as the experience of perinatal expert throughout the world. Physicians are advised to apply these guidelines to the local realities which they face. We plan to update these guidelines as new evidence become available.
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http://dx.doi.org/10.1515/jpm-2020-0265DOI Listing
November 2020

First-trimester screening based on cell-free DNA vs combined screening: A randomized clinical trial on women's experience.

Prenat Diagn 2020 10 13;40(11):1482-1488. Epub 2020 Aug 13.

Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.

Objective: To compare women's experience of first-trimester combined screening (FTCS), with women's experience of an approach that uses the combination of a detailed early anatomy scan and cell-free DNA (cfDNA) analysis.

Methods: This was single-center, open label, parallel group, randomized clinical trial. Pregnant women were randomized at the time of their first prenatal visit to either a policy of first-trimester risk assessment based on FTCS, or to a policy of first-trimester risk assessment based on ultrasound findings and cfDNA. FTCS included ultrasound evaluation with crown-rump length, nuchal translucency (NT) measurement, and a detailed ultrasound scan, along with biochemistry (PAPP-A and free beta hCG). In this group, invasive diagnostic testing was offered to patients with risk >1 in 100, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Women randomized in the intervention group received an approach of first-trimester risk assessment based on ultrasound findings and cfDNA. cfDNA analysis included a simultaneous microarray-based assay of non-polymorphic (chromosomes 13, 18, 21, X and Y) and polymorphic loci to estimate chromosome proportion and fetal fraction. In the intervention group, invasive diagnostic testing was offered to patients with abnormal cfDNA screening results, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Participants received pre-test and post-test questionnaires regarding to measure reassurance, satisfaction, and anxiety. The primary outcome was the post-test reassurance, defined as mean score of reassurance post-test questionnaire. The effect of the assigned screening test on the mean of each outcome was quantified as mean difference (MD) with 95% confidence interval (CI).

Results: Forty women with singleton gestations were enrolled in the trial. Mean score for reassurance was significantly higher in the cfDNA group compared to the FTCS group in the pre-test questionnaire (MD 0.80 points, 95% CI 0.27 to 1.33) and in the post-test questionnaire (MD 16.50 points, 95% CI 2.18 to 30.82). Women randomized to the cfDNA group had higher satisfaction and lower mean anxiety score as assessed in the STAI pre-test questionnaire.

Conclusions: First-trimester risk assessment for fetal aneuploidy with a combination of a detailed ultrasound examination and cfDNA is associated with better maternal reassurance and better maternal satisfaction compared to the standard first-trimester combined screening with nuchal translucency, and biochemistry.

Trial Registration: Clinicaltrials.gov NCT04077060.
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http://dx.doi.org/10.1002/pd.5800DOI Listing
October 2020

Proposal for radiologic diagnosis and follow-up of COVID-19 in pregnant women.

J Matern Fetal Neonatal Med 2020 Jul 16:1-2. Epub 2020 Jul 16.

Department of Neuroscience, Reproductive Sciences and Odontostomatology, School of Medicine, University of Federico II , Naples, Italy.

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http://dx.doi.org/10.1080/14767058.2020.1793325DOI Listing
July 2020

Reply to correspondence: Vaginal delivery in a woman infected with SARS-CoV-2 - The first case reported in Portugal.

Eur J Obstet Gynecol Reprod Biol 2020 Sep 3;252:613. Epub 2020 Jul 3.

Department of Neuroscience, Reproductive Science and Odontostomatology, University of Naples Federico II, Naples, Italy.

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http://dx.doi.org/10.1016/j.ejogrb.2020.07.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7333606PMC
September 2020

The association of skin incision placement during cesarean delivery with wound complications in obese women: a systematic review and meta-analysis.

J Matern Fetal Neonatal Med 2020 Jul 7:1-13. Epub 2020 Jul 7.

Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Thomas Jefferson University Hospital, Philadelphia, PA, USA.

Objective: To determine the risk of wound complications by skin incision type in obese women undergoing cesarean delivery. Electronic databases (MEDLINE, Scopus, and Ovid) were searched from their inception through August 2018. We included all randomized controlled trials and cohort studies reporting the placement of skin incision during cesarean section in obese women, defined as those with BMI ≥30 kg/m. Studies were included if they compared one placement of skin incision with a different one as comparison group. The primary outcome was incidence of wound complications, while secondary outcomes included wound infection, hematoma, seroma, postpartum hemorrhage, and endometritis. Demographics and outcomes for each individual study identified were reported as part of the review. Meta-analysis was performed using the random effects model of DerSimonian and Laird, to produce summary treatment effects in terms of mean difference (MD) or relative risk (RR) with 95% confidence interval (CI). Sub-group analyses (vertical versus Pfannenstiel) were also reported. Seventeen studies (including 3 RCTs; 8960 participants among the 15 non-overlapping studies) were included in the systematic review. Vertical incisions were associated with a relative risk of 2.07 (95% CI1.61-2.67) for wound complications compared to transverse incisions, however significant possible confounders were present. Studies were mildly-moderately heterogeneous ( 44.81%, 95% CI 0.00-71.85%) with varying definitions of obesity and wound complications. High transverse incisions (3 studies, 218 participants) trend toward a lower risk of wound complications compared to low transverse incisions (RR 0.338, 95% CI 0.114-1.004).

Conclusions: Vertical incisions may be associated with an increased risk for wound complications compared to transverse incisions for cesarean delivery in obese women. Randomized controlled trials are needed to evaluate optimal cesarean skin incisions for these women.
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http://dx.doi.org/10.1080/14767058.2020.1786050DOI Listing
July 2020

Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.

Am J Obstet Gynecol 2020 12 25;223(6):902.e1-902.e11. Epub 2020 Jun 25.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA.

Background: Women with twin pregnancies and a dilated cervix in the second trimester are at increased risk of pregnancy loss and early preterm birth; there is currently no proven therapy to prevent preterm birth in this group of women.

Objective: This study aimed to determine whether physical examination-indicated cerclage reduces the incidence of preterm birth in women with a diagnosis of twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation.

Study Design: Multicenter, parallel group, open-label, randomized controlled trial of women with twin pregnancies and asymptomatic cervical dilation of 1 to 5 cm between 16 weeks 0/7 days of gestation and 23 weeks 6/7 days of gestation were enrolled from July 2015 to July 2019 in 8 centers. Eligible women were randomized in a 1:1 ratio into either cerclage or no cerclage groups. We excluded women with monochorionic-monoamniotic twin pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis. The primary outcome was the incidence of preterm birth at <34 weeks of gestation. Secondary outcomes were preterm births at <32, <28, and <24 weeks of gestation, interval from diagnosis to delivery, and perinatal mortality. Data were analyzed by intention-to-treat methods.

Results: After an interim analysis was performed, the Data and Safety Monitoring Board recommended stopping the trial because of a significant decrease in perinatal mortality in the cerclage group. We randomized 34 women, with 4 women being excluded because of expired informed consent. A total of 17 women were randomized to physical examination-indicated cerclage and 13 women to no cerclage. Whereas 4 women randomized to cerclage did not receive the surgical procedure, no women in the no cerclage group received cerclage. Maternal demographics were not significantly different. All women in the cerclage group also received indomethacin and antibiotics. When comparing the cerclage group vs the no cerclage group, the incidence of preterm birth was significantly decreased as follows: preterm birth at <34 weeks of gestation, 12 of 17 women (70%) vs 13 of 13 women (100%) (risk ratio, 0.71; 95% confidence interval, 0.52-0.96); preterm birth at <32 weeks of gestation, 11 of 17 women (64.7%) vs 13 of 13 women (100%) (risk ratio, 0.65; 95% confidence interval, 0.46-0.92); preterm birth at <28 weeks of gestation, 7 of 17 women (41%) vs 11 of 13 women (84%) (risk ratio, 0.49; 95% confidence interval, 0.26-0.89); and preterm birth at <24 weeks of gestation, 5 of 17 women (30%) vs 11 of 13 women (84%) (risk ratio, 0.35; 95% confidence interval, 0.16-0.75). The mean gestational age at delivery was 29.05±1.7 vs 22.5±3.9 weeks (P<.01), respectively; the mean interval from diagnosis of cervical dilation to delivery was 8.3±5.8 vs 2.9±3.0 weeks (P=.02), respectively. Perinatal mortality was also significantly reduced in the cerclage group compared with the no cerclage group as follows: 6 of 34 women (17.6%) vs 20 of 26 women (77%) (risk ratio, 0.22; 95% confidence interval, 0.1-0.5), respectively.

Conclusion: In women with twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation, a combination of physical examination-indicated cerclage, indomethacin, and antibiotics significantly decreased preterm birth at all evaluated gestational ages. Most importantly, cerclage in this population was associated with a 50% decrease in early preterm birth at <28 weeks of gestation and with a 78% decrease in perinatal mortality.
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http://dx.doi.org/10.1016/j.ajog.2020.06.047DOI Listing
December 2020

Type of paternal sperm exposure before pregnancy and the risk of preeclampsia: A systematic review.

Eur J Obstet Gynecol Reprod Biol 2020 Aug 1;251:246-253. Epub 2020 Jun 1.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA. Electronic address:

Objective: The aim of this systematic review was to evaluate the role of paternal sperm exposure before pregnancy on the risk of preeclampsia.

Study Design: The search was conducted using electronic databases from inception of each database through October 2019. Review of articles also included the abstracts of all references retrieved from the search. Only studies evaluating exposure to paternal sperm before pregnancy on the risk of preeclampsia in the subsequent pregnancy were included. Exposure group was defined as significant exposure to paternal sperm, either measured by sexual cohabitation, oral sex habit, or by absence of barrier methods. Control groups was defined as minimal exposure to paternal sperm, either measured by lack of sexual cohabitation or oral sex habit, or by use of barrier methods. Sperm exposure identifiable before pregnancy that may be suspected to modify the risk of preeclampsia was examined. The primary outcome was the incidence of preeclampsia. Subgroup analyses by parity and type of sperm exposure were planned. All analyses were carried out using the random effects model. The pooled results were reported as the OR with 95 % confidence interval (CI). Heterogeneity was measured using I-squared (Higgins I).

Results: Seven studies including 7125 pregnant women were included in this systematic review. Overall, the incidence of preeclampsia was similar in women with a higher overall sperm exposure compared to controls, 774/5512 (14 %) vs 220/1619 (13.6 %); OR 1.04, 95 % CI 0.88-1.22, respectively. The incidence of preeclampsia was significantly reduced in women with a higher overall sperm exposure when including only nulliparous women, 643/3946 (16.1 %) vs 170/725 (23.4 %); OR 0.63, 95 % CI 0.52 to 0.76. Significant lower rate of preeclampsia was also found for ≥12-month sexual cohabitation, 494/3627 (13.6 %) vs 123/691 (17.8 %); OR 0.73, 95 % CI 0.59-0.90. Significantly higher rate of preeclampsia was reported in women not using barrier methods, 315/1904 (16.5 %) vs 103/962 (10.7 %); OR 1.65, 95 % CI 1.30-2.10.

Conclusions: Paternal sperm exposure in nulliparous women and sexual cohabitation > 12 months before pregnancy are associated with a decreased risk of preeclampsia.
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http://dx.doi.org/10.1016/j.ejogrb.2020.05.065DOI Listing
August 2020