Use of metoclopramide in the first trimester and risk of major congenital malformations: A systematic review and meta-analysis

Background Nausea and vomiting of pregnancy affects up to 80% of pregnant women, it typically occurs during the first trimester which is the most sensitive time for environmental exposures given organogenesis. Metoclopramide is an antiemetic drug used widely during NVP, but the findings of studies evaluating its safety of use in pregnancy is inconsistent. Therefore, we conducted a systematic review and meta-analysis to assess whether metoclopramide use during first trimester of pregnancy is associated with the risk of major congenital malformations. Methods The systematic search using database included Pubmed, Embase, Web of science, and Cochrane library. Studies written in English, comprising with an exposed group and a control group, reporting major congenital malformation as an outcome were included. Results Six studies assessing a total number of 33374 metoclopramide-exposed and 373498 controls infants were included in this meta-analysis. No significant increase in the rate of major congenital malformation was detected following metoclopramide use during first trimester (OR, 1.14; 95% CI, 0.93–1.38). Conclusions Metoclopramide use during first trimester of pregnancy was not associated with the risk of major congenital malformations.

P07 Roxithromycin in early pregnancy and the risk of major congenital malformation: a register based nationwide cohort study

BackgroundMedicine use during pregnancy often causes concern for fetal harm. Roxithromycin, a macrolide antibiotic, is regarded as inadvisable to use during pregnancy due to lack of safety data. However, alternative macrolides have been associated with adverse outcomes in pregnancy. We conducted a register-based nationwide cohort study testing the hypothesis that use of roxithromycin in the first trimester is associated with major congenital malformations.MethodsWe included all Danish women giving live birth from 1997 to 2012. Women with at least one redeemed receipt of roxithromycin during first trimester were regarded as exposed. Multivariable logistic regression adjusting for maternal age, multiple birth, parity, year of conception, smoking, educational length, and household income was performed, supplemented by sensitivity analyses comparing unexposed with exposure to increasing accumulated doses of roxithromycin.ResultsThe study included 966,372 pregnancies of which 2,430 children were born to an exposed mother, 78 (3.34%) of the exposed children were diagnosed with a major congenital malformation compared with 33,609 (3.49%) among children born to unexposed mothers. The odds ratio for the occurrence of a major congenital malformation after exposure to roxithromycin was 0.96 (95% CI 0.76–1.20) and multifactorially adjusted 0.94 (0.74–1.18). Sensitivity analyses comparing unexposed with exposure to increasing accumulated doses of roxithromycin showed no dose response relationship. Further, no differences in the type of major malformation according to the EUROCAT subgrouping system were seen.ConclusionsWe found no association between exposure to roxithromycin in the first trimester of pregnancy and major congenital malformations.Disclosure(s)Nothing to disclose

Obstetric and neonatal outcome in women with epilepsy

Background: Epilepsy is the second most common neurological disorder complicating pregnancy next to migraine. Both mother and fetus stay at risk due to epilepsy and side effects of antiepileptic’s. This retrospective study was conducted to study fetal and maternal outcome in WWE.Methods: This study was conducted on 55 patients of epilepsy with pregnancy who attended antenatal clinic of our hospital from January 2016 to December 2016. Data was collected using antenatal registers in outdoor settings and medical case sheets in indoor patients and was analyzed statistically.Results: There were a total of 55 WWE in one year duration. Incidence of epilepsy being 0.4% in this study. 11 WWE were not on ante epileptic drug when conceived, while 34 WWE were on ante epileptic drugs when conceived, 8 WWE were newly diagnosed and 2 patients had both psychiatric disorders along with epilepsy. There were 3 IUDs, 4 major congenital malformation and 2 minor malformations. 2 major malformation occurred in patients taking both antipsychotic and ante epileptics since conception.Conclusions: There were a total of 55 WWE in one year duration. Incidence of epilepsy being 0.4% in this study. 11 WWE were not on ante epileptic drug when conceived, while 34 WWE were on ante epileptic drugs when conceived, 8 WWE were newly diagnosed and 2 patients had both psychiatric disorders along with epilepsy. There were 3 IUDs, 4 major congenital malformation and 2 minor malformations. 2 major malformation occurred in patients taking both antipsychotic and ante epileptics since conception.

Trimethoprim Use prior to Pregnancy and the Risk of Congenital Malformation: A Register-Based Nationwide Cohort Study

Objectives. The aim of the study was to investigate whether the use of the antifolate antibiotic trimethoprim during the 12 weeks before conception was associated with congenital malformations.Methods. We conducted a nationwide register-based cohort study including all Danish women giving birth from 1997 to 2004. All women with at least one prescription of trimethoprim dispensed during the 12 weeks before conception were identified.Results. There was a doubling of congenital malformations in offspring to women exposed to trimethoprim in the 12 weeks before conception. The adjusted odds ratio (OR) of major congenital malformation was 1.87, 95% confidence interval (CI) 1.25–2.81. There was a significant increase in major malformations of the heart (OR=2.49; 1.18–5.26) and limbs (OR=2.18; 1.13–4.23).Conclusions. In this study, we found an association between exposure to trimethoprim during the 12 weeks before conception and an increased risk of heart and limb defects.

Duration of antidepressant use during pregnancy and risk of major congenital malformations

BackgroundAntidepressant use during the gestational period is a controversial topic.AimsTo determine whether duration of antidepressant use during the first trimester increases the risk of major congenital malformations in offspring of women diagnosed with psychiatric disorders.MethodA case-control study was performed among women who had been pregnant between January 1998 and December 2002. Data were obtained from a Medication and Pregnancy registry, built by linking three databases from the province of Quebec, and a self-administered questionnaire. Women eligible for this study had to be 15–45 years old at the beginning of pregnancy, have at least one diagnosis of psychiatric disorder before pregnancy, have used antidepressants for ≥ 30 days in the year prior to pregnancy and have a pregnancy ending with a delivery. Cases were defined as any major congenital malformation diagnosed in the offspring's first year of life. Odds ratios, adjusted for relevant confounders, were estimated using logistic regression.ResultsAmong the 2329 women meeting the inclusion criteria, 189 (8.1%) infants were born with a major congenital malformation. Duration of antidepressant use during the first trimester of pregnancy was not associated with an increased risk of major congenital malformations: 1–30 days v. 0 day, adjusted OR=1.23 (95% CI 0.77–1.98); 31–60 days v. 0 day, adjusted OR=1.03 (95% CI 0.63–1.69); ≥ 61 days v. 0 day, adjusted OR=0.92 (95% CI 0.50–1.69).ConclusionsThese data do not support an association between duration of antidepressant use during the first trimester of pregnancy and major congenital malformations in the offspring of women with psychiatric disorders. These findings should help clinicians decide whether to continue antidepressant therapy during pregnancy.

Perinatal Mortality and Prevalence of Major Congenital Malformations of Twins in Taipei City

In order to examine perinatal mortality and prevalence of major congenital malformations in twins, deliveries in four teaching hospitals in Taipei City were studied. Among a total of 73,264 deliveries from October 1985 to June 1989, there were 844 pairs of twins. The zygosity of the twin pairs was determined by sex, placentation and 12 red blood cell antigens. There were 482 MZ and 252 DZ twin pairs identified, but the zygosity of a further 110 twin pairs was indeterminable due to lack of information on plancentation and/or blood types. A total of 4,573 singletons delivered in one study hospital from July 1986 to June 1987 were also studied as controls. The perinatal mortality rate was 7.5% for MZ twins, 1.4% for DZ twins, and 0.7% for singletons. The concordance rate of perinatal death was significantly higher in MZ (60%) than in DZ (0%) twins. The prevalence of major congenital malformations was 2.7% for MZ twins, 1.0% for DZ twins, and 0.6% for singletons. The concordance rate of major congenital malformations was 18% for MZ twins, but no DZ pair was concordant in any major congenital malformation. The concordance rate of facial clefts was 29% for MZ twins. There were 2 sets of conjoined twins giving a prevalence rate of 2.7 per 100,000 deliveries. These findings showing the prevalence of perinatal mortality and major congenital malformation to be highest in MZ twins, intermediate in DZ twins and lowest in singletons, suggest the importance of intrauterine environments in the determination of perinatal mortality and congenital malformations.

Counseling Families Who Have a Child with a Severe Congenital Anomaly

The birth of an infant with a major congenital malformation is experienced by the family as a calamity. Parents have an urgent need for compassionate and skilled attention, and a long-term need for counseling to help them adapt to the crisis. The difficult ethical and legal implications of such cases further complicate the doctor's ability to care for the patient and family. Potential conflicts of interest have recently led to the use of voluntary consultation by hospital committees, or obligatory involvement by the courts.