Impact of an e-learning training for interpreting intrapartum fetal heart rate monitoring to avoid perinatal asphyxia: A before-after multicenter observational study.

INTRODUCTION: Perinatal asphyxia, a condition that results from compromised placental or pulmonary gas exchange during the birth process, is rare but can lead to serious neonatal and long-term consequences. The visual analysis of cardiotocography (CTG) is designed to avoid perinatal asphyxia, but its interpretation can be difficult. Our aim was to test the impact of an e-learning training program for interpreting CTG on the rate of avoidable perinatal asphyxia at term. METHOD: We conducted a retrospective multicenter before-after study comparing two periods, before and after the implementation of e-learning training program from July 1, 2016 to December 31, 2016, in CTG interpretation for midwives and obstetricians in five maternity hospitals in the Paris area, France. The training involved theoretical aspects such as fetal physiology and heart rhythm abnormalities, followed by practical exercises using real case studies to enhance skills in interpreting CTG. We included all term births that occurred between the "before" period (July 1 to December 31, 2014) and the "after period (January 1 to June 30, 2017). We excluded multiple pregnancies, antenatal detection of congenital abnormalities, breech births and all scheduled caesarean sections. Perinatal asphyxia cases were analyzed by a pair of experts consisting of midwives and obstetricians, and avoidability of perinatal asphyxia was estimated. The main criterion was the prevalence of avoidable perinatal asphyxia. RESULTS: The e-learning program was performed by 83 % of the obstetrician-gynecologists and 65 % of the midwives working in the delivery rooms of the five centers. The prevalence of perinatal asphyxia was 0.45 % (29/7902 births) before the training and 0.54 % (35/7722) after. The rate of perinatal asphyxia rated as avoidable was 0.30 % of live births before the training and 0.28 % after (p = 0.870). The main causes of perinatal asphyxia deemed avoidable were delay in reactions to severe CTG anomalies and errors in the analysis and interpretation of the CTG. These causes did not differ between the two periods. CONCLUSION: One session of e-learning training to analyze CTG was not associated with a reduction in avoidable perinatal asphyxia. Other types of e-learning, repeated and implemented over a longer period should be evaluated.

Risk Factors for Anal Continence Impairment Following a Second Delivery after a First Traumatic Delivery: A Prospective Cohort Study.

Postpartum anal incontinence is common. After a first delivery (D1) with perineal trauma, follow-up is advised to reduce the risk of anal incontinence. Endoanal sonography (EAS) may be considered to evaluate the sphincter and in case of sphincter lesions to discuss cesarean section for the second delivery (D2). Our objective was to study the risk factors for anal continence impairment following D2. Women with a history of traumatic D1 were followed before and 6 months after D2. Continence was measured using the Vaizey score. An increase ≥2 points after D2 defined a significant deterioration. A total of 312 women were followed and 67 (21%) had worse anal continence after D2. The main risk factors for this deterioration were the presence of urinary incontinence and the combined use of instruments and episiotomy during D2 (OR 5.12, 95% CI 1.22-21.5). After D1, 192 women (61.5%) had a sphincter rupture revealed by EAS, whereas it was diagnosed clinically in only 48 (15.7%). However, neither clinically undiagnosed ruptures nor severe ruptures were associated with an increased risk of continence deterioration after D2, and cesarean section did not protect against it. One woman out of five in this population had anal continence impairment after D2. The main risk factor was instrumental delivery. Caesarean section was not protective. Although EAS enabled the diagnosis of clinically-missed sphincter ruptures, these were not associated with continence impairment. Anal incontinence should be systematically screened in patients presenting urinary incontinence after D2 as they are frequently associated.

Frequency of differential placental transfer to twins of maternal antiretroviral medications.

BACKGROUND: Placental passage of drugs in twins is poorly understood, and is unknown regarding antiretrovirals (ARVs). In the event of large differences in the exposure of 2 twins to the same maternal therapy, this could have a clinical impact in terms of prevention of perinatal HIV transmission or adverse effects. OBJECTIVE: To describe the frequency of differential transplacental passage of antiretrovirals between twins. STUDY DESIGN: The study was performed retrospectively, on data from women included in a multicenter perinatal HIV cohort study. All twin pairs for which the mother received antiretroviral therapy and for which drug concentrations in both of the umbilical cords after cord clamping at delivery were studied. We considered that a difference in concentrations of more than 50 % between twins was a substantial difference (ratios below 0.67 or above 1.50). RESULTS: We analyzed 29 twin pairs, 27 dichorionic and 2 monochorionic diamniotic. Cord blood concentrations differed between the 2 twins by more than 50 % for at least one ARV in 9 twin pairs, 8 dichorionic and 1 monochorionic. Discordant concentrations were observed in one or more cases for several nucleoside reverse transcriptase inhibitors (tenofovir, emtricitabine, lamivudine, zidovudine) and protease inhibitors (atazanavir, lopinavir, saquinavir et ritonavir); within individual twin pairs placental transfer was discordant for one or more ARVs, but identical for others. CONCLUSION: Concentrations differed in nearly one third of twin pairs. This may be due to interindividual genetic variability of placental transporters between dizygotic twins as well as physiological differences between twins.

Congenital Leishmaniasis in a Newborn Infant Whose Mother was Coinfected With Leishmaniasis and HIV.

In utero transmission of Leishmania infantum is the putative mechanism of congenital leishmaniasis. However, this hypothesis is based on limited research. In addition, the consequences for infant newborn development remain to be clarified by additional data. We report here the occurrence, specific management, and monitoring of congenital leishmaniasis in a newborn infant whose mother was coinfected with leishmaniasis and human immunodeficiency virus; transplacental transmission, confirmed by overt clinical disease at birth, was documented, which provides, to our knowledge, the first evidence of hepatic and neurologic impairment in an infant with congenital visceral leishmaniasis.

Pregnancy denial and early infant development: a case-control observational prospective study.

BACKGROUND: The denial of pregnancy is the non-recognition of the state of the current pregnancy by a pregnant woman. It lasts for a few months or for the whole pregnancy, with generally few physical transformations. In this study, we will consider the denial of pregnancy as a late declaration of pregnancy (beyond 20 weeks of gestation) as well as a lack of objective perceptions of this pregnancy. The main objective of this study is to explore the relationship between pregnancy denial and the development of the infant (attachment pattern of the infant, early interactions of mother-infant dyads, and early development of the infant). METHODS: The design is a case-control prospective study, which will compare two groups of mother-infant dyads: a "case" group with maternal denials of pregnancy and a "control" group without denials of pregnancy. A total of 140 dyads (mother + infant) will be included in this study (70 cases and 70 controls) and followed for 18 months. The setting is a national recruitment setting with 10 centers distributed all over France. The follow-up of the "cases" and the "controls" will be identical and will occur over 5 visits. It will include measures of the infant attachment pattern, the quality of early mother-infant interaction and infant development. DISCUSSION: This study aims to examine the pathogenesis of pregnancy denial as well as its consequences on early infant development and early mother-infant interaction. TRIAL REGISTRATION: Clinical Trial Number: NCT02867579 on the date of 16 August 2016 (retrospectively registered).

Does Changing Antiretroviral Therapy in the First Trimester of Pregnancy for Safety Concerns Have an Impact on Viral Suppression?

OBJECTIVE: To determine whether changing antiretroviral therapy (ART) during pregnancy because of concern about fetal risks led to poorer virological outcomes. METHODS: All pregnancies in women with HIV-1 infection enrolled in the national multicenter prospective French Perinatal cohort at 14 week gestation or more were included between January 2005 and December 2015, if the mother was on ART at conception with a plasma viral load <50 copies/mL. The reasons for a change in the ART were analyzed according to treatment guidelines at the time of the pregnancy and defined as for safety concerns in the absence of reported maternal intolerance. Virological and pregnancy outcomes were studied by survival analysis and logistic regression adjusted for a propensity score established for each patient according to baseline characteristics. RESULTS: Of 7079 pregnancies in the overall cohort, 1797 had ART at conception with a viral load <50 copies/mL before 14 week gestation. Of these, 22 changed regimens in the first trimester for intolerance, and 411 of the remaining 1775 (23%) solely for safety concerns. The proportion of change was higher when the initial treatment was not recommended in the national guidelines (OR adjusted: 23.1 [14.0-38.2]), than when it was an alternative option (ORa: 2.2 [1.3-3.7]), as compared to recommended first-line regimens. Treatment changes for safety concerns did not lead to poorer virological control, compared with pregnancies without such changes (19.3% vs. 15.6%, HRa: 1.0 [0.7-1.4]). CONCLUSIONS: Changing ART early in pregnancy to regimens considered safer for pregnancy, and neonatal health did not have a destabilizing effect on viral suppression.

Prevention of shoulder dystocia: A randomized controlled trial to evaluate an obstetric maneuver.

OBJECTIVE: Shoulder dystocia is a major obstetric emergency defined as a failure of delivery of the fetal shoulder(s). This study evaluated whether an obstetric maneuver, the push back maneuver performed gently on the fetal head during delivery, could reduce the risk of shoulder dystocia. STUDY DESIGN: We performed a multicenter, randomized, single-blind trial to compare the push back maneuver with usual care in parturient women at term. The primary outcome, shoulder dystocia, was considered to have occurred if, after delivery of the fetal head, any additional obstetric maneuver, beginning with the McRoberts maneuver, other than gentle downward traction and episiotomy was required. RESULTS: We randomly assigned 522 women to the push back maneuver group (group P) and 523 women to the standard vaginal delivery group (group S). Finally, 473 women assigned to group P and 472 women assigned to group S delivered vaginally. The rate of shoulder dystocia was significantly lower in group P (1·5%) than in group S (3·8%) (odds ratio [OR] 0·38 [0·16-0·92]; P = 0·03). After adjustment for predefined main risk factors, dystocia remained significantly lower in group P than in group S. There were no significant between-group differences in neonatal complications, including brachial plexus injury, clavicle fracture, hematoma and generalized asphyxia. CONCLUSION: In this trial in 945 women who delivered vaginally, the push back maneuver significantly decreased the risk of shoulder dystocia, as compared with standard vaginal delivery.

Pharmacokinetics, safety and efficacy of ritonavir-boosted atazanavir (300/100 mg once daily) in HIV-1-infected pregnant women.

BACKGROUND: Atazanavir/ritonavir (ATV/r) is a boosted protease inhibitor recommended to minimize the risk of mother-to-child HIV-1 transmission (MTCT). We aimed to assess the pharmacokinetics, safety and efficacy of ATV/r in HIV-1-infected pregnant women and their neonates. METHODS: A multicentre, cross-sectional, non-interventional cohort of HIV-1-infected pregnant women receiving ATV/r (300/100 mg once daily) who delivered in three Paris hospitals from 2006 to 2013 was designed. We determined antiretroviral trough plasma concentrations using liquid chromatography-mass spectrometry at each of the three trimesters, delivery and post-partum. ATV concentrations at 24 h (C24h) were interpreted by the 150-850 ng/ml efficacy-tolerance thresholds. Safety data and newborn HIV status were recorded. A mother's virological failure was defined as two successive measurements of plasma HIV-1 RNA>50 copies/ml within the 2 months before delivery. RESULTS: 103 pregnant women were included, mostly from sub-Saharan Africa (88%). ATV C24h at each of the three trimesters and delivery remained similar to post-partum values. No dose adjustment was needed during pregnancy. The median plasma ratio of fetal/maternal ATV level was 0.19 (n=28). Only three patients showed two successive detectable viral loads but <400 copies/ml. Among 82 available newborn data, 16 were born preterm. Three in utero deaths occurred. Tolerance was good with one case of maternal grade 3 hyperbilirubinaemia, no cases in neonates at delivery and no clinically relevant adverse event. No case of MTCT was reported. CONCLUSIONS: In this population, an ATV/r-containing antiretroviral regimen demonstrated good pharmacokinetics, virological efficacy and safety. No significant impact of pregnancy on ATV C24h was found. No dose adjustment was required.