Scientific Evidence for Different Options for GDM Screening and Management: Controversies and Review of the Literature.

Background. Gestational diabetes (GDM) affects up to 7% of pregnant women and is associated with several maternal and perinatal morbidities. International organizations suggest several different recommendations regarding how to screen and to manage GDM. Objective. We aimed to analyze the most important and employed guidelines about screening and management of GDM and we investigated existing related literature. Results. We found several different criteria for screening for GDM, for monitoring GDM, and for starting pharmacological therapy. When using IADPSG criteria, GDM rate increased, perinatal outcomes improved, and screening became cost-effective. Compared to no treatment, treatment of women meeting criteria for GDM by IADPSG criteria but not by other less strict criteria has limited evidence for an effect on adverse pregnancy outcomes

Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines.

BACKGROUND: Guidelines for management of the second stage have been proposed since the 1800s and were created largely by expert opinion. Current retrospective data are mixed regarding differences in maternal and neonatal outcomes with a prolonged second stage. There are no randomized controlled trials that have evaluated whether extending the second stage of labor beyond current American College of Obstetricians and Gynecologists recommendations is beneficial. OBJECTIVE: The purpose of this study was to evaluate whether extending the length of labor in nulliparous women with prolonged second stage affects the incidence of cesarean delivery and maternal and neonatal outcomes. STUDY DESIGN: We conducted a randomized controlled trial of nulliparous women with singleton gestations at 36 0/7 to 41 6/7 weeks gestation who reached the American College of Obstetricians and Gynecologists definition of prolonged second stage of labor, which is 3 hours with epidural anesthesia or 2 hours without epidural anesthesia. Women were assigned randomly to extended labor for at least 1 additional hour, or to usual labor, which was defined as expedited delivery via cesarean or operative vaginal delivery. The exclusion criteria were intrauterine fetal death, planned cesarean delivery, ageyears, and suspected major fetal anomaly. Primary outcome was incidence of cesarean delivery. Maternal and neonatal outcomes were compared secondarily. Statistical analysis was done by intention-to-treat. RESULTS: Seventy-eight nulliparous women were assigned randomly. All of the women had epidural anesthesia. Maternal demographics were not significantly different. The incidence of cesarean delivery was 19.5% (n = 8/41 deliveries) in the extended labor group and 43.2% (n = 16/37 deliveries) in the usual labor group (relative risk, 0.45; 95% confidence interval, 0.22-0.93). The number needed-to-treat to prevent 1 cesarean delivery was 4.2. There were no statistically significant differences in maternal or neonatal morbidity outcomes. CONCLUSION: Extending the length of labor in nulliparous women with singleton gestations, epidural anesthesia, and prolonged second stage decreased the incidence of cesarean delivery by slightly more than one-half, compared with usual guidelines. Maternal or neonatal morbidity were not statistically different between the groups; however, our study was underpowered to detect small, but potentially clinical important, differences

Progesterone and Preterm Birth Prevention: Translating Clinical Trials Data into Clinical Practice

OBJECTIVE: We sought to provide evidence-based guidelines for using progestogens for the prevention of preterm birth (PTB). METHODS: Relevant documents, in particular randomized trials, were identified using PubMed (US National Library of Medicine, 1983 through February 2012) publications, written in English, which evaluate the effectiveness of progestogens for prevention of PTB. Progestogens evaluated were, in particular, vaginal progesterone and 17-alpha-hydroxy-progesterone caproate. Additionally, the Cochrane Library, organizational guidelines, and studies identified through review of the above were utilized to identify relevant articles. Data were evaluated according to population studied, with separate analyses for singleton vs multiple gestations, prior PTB, or short transvaginal ultrasound cervical length (CL), and combinations of these factors. Consistent with US Preventive Task Force suggestions, references were evaluated for quality based on the highest level of evidence, and recommendations were graded. RESULTS AND RECOMMENDATIONS: Summary of randomized studies indicates that in women with singleton gestations, no prior PTB, and short CL ≤20 mm at ≤24 weeks, vaginal progesterone, either 90-mg gel or 200-mg suppository, is associated with reduction in PTB and perinatal morbidity and mortality, and can be offered in these cases. The issue of universal CL screening of singleton gestations without prior PTB for the prevention of PTB remains an object of debate. CL screening in singleton gestations without prior PTB cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners, following strict guidelines. In singleton gestations with prior PTB 20-36 6/7 weeks, 17-alpha-hydroxy-progesterone caproate 250 mg intramuscularly weekly, preferably starting at 16-20 weeks until 36 weeks, is recommended. In these women with prior PTB, if the transvaginal ultrasound CL shortens to \u3c25 mm at \u3c24 weeks, cervical cerclage may be offered. Progestogens have not been associated with prevention of PTB in women who have in the current pregnancy multiple gestations, preterm labor, or preterm premature rupture of membranes. There is insufficient evidence to recommend the use of progestogens in women with any of these risk factors, with or without a short CL. Copyright © 2012. Published by Mosby, Inc

Fetal fibronectin testing for reducing the risk of preterm birth.

BACKGROUND: Fetal fibronectin (FFN) is an extracellular matrix glycoprotein localized at the maternal-fetal interface of the amniotic membranes, between chorion and decidua, where it is concentrated in this area between decidua and trophoblast. In normal conditions, FFN is found at very low levels in cervicovaginal secretions. Levels greater than or equal to 50 ng/mL at or after 22 weeks have been associated with an increased risk of spontaneous preterm birth. In fact, FFN is one of the best predictors of preterm birth in all populations studied so far, and can help in selecting which women are at significant risk for preterm birth. This is an update of a review first published in 2008. OBJECTIVES: To assess the effectiveness of management based on knowledge of FFN testing results for preventing preterm birth. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth\u27s Trials Register (7 September 2018), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 September 2018), and reference lists of retrieved studies. SELECTION CRITERIA: Randomized controlled trials of pregnant women screened with FFN for risk of preterm birth. Studies included are based exclusively on knowledge of FFN results versus no such knowledge, and we have excluded studies including women with only positive or only negative FFN results. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: We identified 16 trials, of which six were eligible for inclusion. The six included studies randomized 546 women with singleton gestations and threatened preterm labor (PTL) at 23 0/7 to 34 6/7 weeks. A total of 277 women were randomized to knowledge and 269 to no knowledge of FFN. No trials were identified on asymptomatic women or multiple gestations.The risk of bias of included studies was mixed. For selected important outcomes, preterm birth before 37, 34, and 32 weeks, and maternal hospitalization, we graded the quality of the evidence and created a \u27Summary of findings\u27 table. For these outcomes, the evidence was graded as mainly low quality due to the imprecision of effect estimates.Management based on knowledge of FFN results may reduce preterm birth before 37 weeks (21.6%) versus controls without such knowledge (29.2%) (risk ratio (RR) 0.72, 95% confidence interval (CI) 0.52 to 1.01; 4 trials; 357 women; low-quality evidence). However, management based on knowledge of FFN results may make little or no difference to preterm birth before 34 (RR 1.09, 95% CI 0.54 to 2.18; 4 trials; 357 women; low-quality evidence) or maternal hospitalization (RR 1.06, 95% CI 0.79 to 1.43; 5 trials; 441 women; low-quality evidence). The evidence for preterm birth before 32 weeks is uncertain because the quality was found to be very low (average RR 0.79, 95% CI 0.16 to 3.96; 4 trials; 357 women; very low-quality evidence).For all other outcomes, for which there were available data (preterm birth less than 28 weeks; gestational age at delivery (weeks); birthweight less than 2500 g; perinatal death; tocolysis; steroids for fetal lung maturity; time to evaluate; respiratory distress syndrome; neonatal intensive care unit (NICU) admission; and NICU days), knowledge of FFN results may make little or no difference to the outcomes. AUTHORS\u27 CONCLUSIONS: The evidence from this review suggests that management based on knowledge of FFN results may reduce preterm birth before 37 weeks. However, our confidence in this result is limited as the evidence was found to be of low quality. Effects on other substantive outcomes are uncertain due to serious concerns in study design, inconsistency, and imprecision of effect estimates. No trials were identified on asymptomatic women, or multiple gestations.Future studies are needed that include specific populations (e.g. singleton gestations with symptoms of preterm labor), a study group managed with a protocol based on the FFN results, and that report not only maternal but also important perinatal outcomes. Cost-effectiveness analyses are also needed

Cervical assessment by ultrasound for preventing preterm delivery.

BACKGROUND: Measurement of cervical length by ultrasound is predictive of preterm birth (PTB). There are three methods of ultrasound cervical assessment: transvaginal (TVU), transabdominal (TAU), and transperineal (TPU, also called translabial). Cervical length measured by TVU is a relatively new screening test, and has been associated with better prediction of PTB than previously available tests. It is unclear if cervical length measured by ultrasound is effective for preventing PTB. This is an update of a review last published in 2013. OBJECTIVES: To assess the effectiveness of antenatal management based on transvaginal, transabdominal, and transperineal (also called translabial) ultrasound screening of cervical length for preventing preterm birth. SEARCH METHODS: For this update, we searched the Cochrane Pregnancy and Childbirth\u27s Trials Register, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) to 30 August 2018; reviewed the reference lists of all articles, and contacted experts in the field for additional and ongoing trials. SELECTION CRITERIA: We included published and unpublished randomised controlled trials (RCT) including pregnant women between the gestational ages of 14 to 32 weeks, for whom the cervical length was screened for risk of PTB with TVU, TAU, or TPU. This review focused on studies based on knowledge versus no knowledge of cervical length results, or ultrasound versus no ultrasound for cervical length. We excluded studies based on interventions (e.g. progesterone, cerclage) for short cervical length. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. MAIN RESULTS: We included seven RCTs (N = 923): one examined asymptomatic women with twin pregnancies; four included women with singleton pregnancies and symptoms of preterm labour (PTL); one included women with singleton pregnancies and symptoms of preterm premature rupture of membranes (PPROM); and one included asymptomatic singletons. All trials used TVU for screening.We assessed the risk of bias of the included studies as mixed, and the quality of the evidence for primary outcomes as very low for all populations.For asymptomatic women with twin pregnancies, it is uncertain whether knowledge of TVU-measured cervical length compared to no knowledge reduces PTB at less than 34 weeks (risk ratio (RR) 0.62, 95% confidence intervals (CI) 0.30 to 1.25; 1 study, 125 participants) because the quality of the evidence is very low. The results were also inconclusive for preterm birth at 36, 32, or 30 weeks; gestational age at birth, and other maternal and perinatal outcomes.Four trials examined knowledge of TVU-measured cervical length of singletons with symptoms of PTL versus no knowledge. We are uncertain of the effects because of inconclusive results and very low-quality evidence for: preterm births at less than 37 weeks (average RR 0.59, 95% CI 0.26 to 1.32; 2 studies, 242 participants; I² = 66%; Tau² = 0.23). Birth occurred about four days later in the knowledge groups (mean difference (MD) 0.64 weeks, 95% CI 0.03 to 1.25; 3 trials, 290 women). The results were inconclusive for the other outcomes for which there were available data: PTB at less than 34 or 28 weeks; birthweight less than 2500 g; perinatal death; maternal hospitalisation; tocolysis; and steroids for fetal lung maturity.The trial of singletons with PPROM (N = 92) evaluated safety of using TVU to measure cervical length in this population as its primary outcome, not its effect on management. The results were inconclusive for incidence of maternal and neonatal infections between the TVU and no ultrasound groups.In the trial of asymptomatic singletons (N = 296), in which women either received TVU or not, the results were inconclusive for preterm birth at less than 37 weeks (RR 1.27, 95% CI 0.61 to 2.61; I² = 0%), gestational age at birth, and other perinatal and maternal outcomes.We downgraded evidence for limitations in study design, inconsistency between the trials, and imprecision, due to small sample size and wide confidence intervals crossing the line of no effect.No trial compared the effect of knowledge of the CL with no knowledge of CL in other populations, such as asymptomatic women with singleton pregnancies, or symptomatic women with twin pregnancies. AUTHORS\u27 CONCLUSIONS: There are limited data on the effects of knowing the cervical length, measured by ultrasound, for preventing preterm births, which preclude us from drawing any conclusions for women with asymptomatic twin or singleton pregnancies, singleton pregnancies with PPROM, or other populations and clinical scenarios.Limited evidence suggests that knowledge of transvaginal ultrasound-measured cervical length, used to inform the management of women with singleton pregnancies and symptoms of preterm labour, appears to prolong pregnancy by about four days over women in the no knowledge groups.Future studies could look at specific populations separately (e.g. singleton versus twins; symptoms versus no symptoms of PTL), report on all pertinent maternal and perinatal outcomes, and include cost-effectiveness analyses. Most importantly, future studies should include a clear protocol for management of women based on TVU-measured cervical length

MFM Guidance for COVID-19

The World Health Organization (WHO) has declared COVID-19 a global pandemic. Healthcare providers should prepare internal guidelines covering all aspect of the organization in order to have their unit ready as soon as possible. This document addresses the current COVID-19 pandemic for maternal-fetal medicine (MFM) practitioners. The goals the guidelines put forth here are two fold- first to reduce patient risk through healthcare exposure, understanding that asymptomatic health systems/healthcare providers may become the most common vector for transmission, and second to reduce the public health burden of COVID-19 transmission throughout the general population. Box 1 outlines general guidance to prevent spread of COVID-19 and protect our obstetric patients. Section 1 outlines suggested modifications of outpatient obstetrical (prenatal) visits. Section 2 details suggested scheduling of obstetrical ultrasound. Section 3 reviews suggested modification of nonstress tests (NST) and biophysical profiles (BPP). Section 4 reviews suggested visitor policy for obstetric outpatient office. Section 5 discusses the role of trainees and medical education in the setting of a pandemic. These are suggestions, which can be adapted to local needs and capabilities. Guidance is changing rapidly, so please continue to watch for updates

Pregnancy after liver transplantation: a case series and review of the literature

Objective: To evaluate maternal and perinatal outcomes in pregnant women after liver transplantation with a case series and literature systematic review. Methods: This was a single-center case-series study performed at University of Naples Federico II. All consecutive women with liver transplantation who reported pregnancy at our institution were included in a dedicated database. In addition, a systematic literature review was performed, including case series, population-based studies, and national registries, including maternal and perinatal outcomes of pregnant women with liver transplant. Studies with fewer than 10 cases and surveys were excluded. The primary outcome was perinatal death, defined as either stillbirth (defined as intrauterine fetal death after 20 weeks of gestation) or neonatal death (death of a live-born infant within the first 28 d of life). Results: During the study period, two women who underwent liver transplantation had a pregnancy in our Institution. Both of them underwent liver transplantation for biliary atresia at 1 year of age. One of them received cyclosporin as immunosuppressive regime during pregnancy, while the other one received tacrolimus. Both of them had a pregnancy with no major complications and delivered by cesarean section at term a baby with normal weight. One of them developed thrombocytopenia. Seventeen articles were included in this systematic review. Preterm birth at less than 37 weeks of gestations occurred in 279 women (33.6%). One-hundred women (14.9%) experienced preeclampsia, and 206 women (49.2%) delivered by cesarean delivery. Graft rejection related to pregnancy occurred in 73 women (8.3%). 117 women (12.9%) experienced miscarriage, and 22 (2.3%) IUFD. Fifty-two women (9.52%) underwent elective I-TOP. 195 fetuses (33.4%) were LBW. Eight neonatal deaths were recorded (1.3%). Conclusion: The maternal and perinatal outcome is usually favorable, but with an increased risk of preeclampsia, preterm birth, and perinatal morbidity and mortality. However, appropriate counseling about risks and complications is essential but women shouldn't be advised against pregnancy