Dataset Information

Fetal loss and malformations in the MONEAD study of pregnant women with epilepsy.

ABSTRACT:

Objective

To examine occurrence of severe adverse fetal outcomes (SAO), including fetal loss and major congenital malformations (MCMs), in pregnant women with epilepsy (PWWE) vs healthy pregnant women (HPW).

Methods

The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is an NIH-funded, prospective, observational, multicenter investigation of pregnancy outcomes for both mother and child, which enrolled women December 2012 through January 2016.

Results

The 351 PWWE had 365 conceptions, and 105 HPW had 109 conceptions. SAOs occurred more often in PWWE (7.9%) vs HPW (1.9%) (p = 0.025) with odds ratio (OR) 4.45 (95% confidence intervals [CI] 1.04-19.01). There were no significant differences for fetal loss (2.8% vs 0%, p = 0.126) or MCMs (5.2% vs 1.9%, p = 0.185; OR 2.86, 95% CI 0.65-12.53) individually. No fetal losses in PWWE appeared to be related to acute seizures. Outcomes were not affected by periconceptional folate, unplanned/unwanted pregnancies, prior maternal pregnancy history, or antiepileptic drug (AED) blood levels, except for an AED level effect for fetal loss that appeared to be due to polytherapy. Combined maternal or paternal family history of MCM was marginally associated with increased SAOs (p = 0.046).

Conclusions

The findings provide additional information on risks of SAOs in PWWE, assessing effects of both AED levels and periconceptional folate. Group differences in average enrollment gestational age could have affected fetal loss results. Analyses are limited by small sample sizes as the MONEAD study was not powered for these secondary outcomes. The large majority of pregnancies in women with epilepsy do not have SOAs.

SUBMITTER: Meador KJ

PROVIDER: S-EPMC7251524 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceIf unintended pregnancy is common among women with epilepsy and is associated with increased risk of spontaneous fetal loss (SFL), it is important to develop guidelines for safe and effective contraception for this community.ObjectiveTo assess whether planned pregnancy is a determinant of SFL in women with epilepsy.Design, setting, and participantsThe Epilepsy Birth Control Registry conducted this web-based, retrospective survey between 2010 and 2014. It gathered demographic, epilepsy, antiepileptic drug (AED), contraceptive, and reproductive data from 1144 women with epilepsy in the community between ages 18 and 47 years. Data were analyzed between March 2018 and May 2018.Main outcomes and measuresThe primary outcome was the risk ratio (RR) with 95% confidence intervals for SFL in unplanned vs planned pregnancies. The secondary outcome was the identification of some potentially modifiable variables (maternal age, pregnancy spacing, and AED category) of SFL vs live birth using binary logistic regression.ResultsThe participants were proportionally younger (mean [SD] age, 28.5 [6.8] years), and 39.8% had household incomes of $25 000 or less. Minority women represented only 8.7% of the participants. There were 530 of 794 unplanned pregnancies (66.8%) and 264 of 794 planned pregnancies (33.2%). The risk for SFL in 653 unaborted pregnancies in women with epilepsy was greater for unplanned (n = 137 of 391; 35.0%) than planned (n = 43 of 262; 16.4%) pregnancies (RR, 2.14; 95% CI, 1.59-2.90; P < .001). Regression analysis found that the risk for SFL was greater when planning was entered alone (odds ratio [OR], 2.75; 95% CI, 1.87-4.05; P < .001) and more so when adjusted for maternal age, interpregnancy interval, and AED category (OR, 3.57; 95% CI, 1.54-8.78; P = .003). Interpregnancy interval (OR, 2.878; 95% CI, 1.8094-4.5801; P = .008) and maternal age (OR, 0.957; 95% CI, 0.928-0.986 for each year from 18 to 47 years; P = .02), but not AED category, were also associated. The risk was greater when interpregnancy interval was less than 1 year (n = 56 of 122; 45.9%) vs greater than 1 year (n = 56 of 246; 22.8%) (RR, 2.02; 95% CI, 1.49-2.72; P < .001). Relative to the younger than 18 years cohort (n = 15 of 29; 51.7%), the risks were lower for the intermediate older cohort aged 18 to 27 years (n = 118 of 400; 29.5%; RR, 0.57; 95% CI, 0.39-0.84; P < .004) and the cohort aged 28 to 37 years (n = 44 of 212; 20.8%; RR, 0.40; 95% CI, 0.26-0.62; P < .001) but not significantly different for the small number of participants in the aged 38 to 47 years cohort (n = 3 of 12; 25.0%). No individual AED category's SFL frequency differed significantly from the no AED category.Conclusions and relevanceThe Epilepsy Birth Control Registry retrospective survey finding that unplanned pregnancy in women with epilepsy may double the risk for SFL warrants prospective investigation with outcome verification.

Project description:Background Maternal anemia is a common nutritional problem during pregnancy. Fetal heart quantification (fetal HQ) technology is used to quantitatively evaluate the size, shape, and contractile function of the fetal heart, which can reflect the development of the fetus in the uterus. Methods We used fetal HQ technology to evaluate the basal-apical length (BAL), the transverse width (TW) and the area (A) of the four chamber view at end-diastole in 77 normal fetuses and 40 fetuses of women with anemia. We analyzed the changes of fetal heart size and measured the global sphericity index (GSI), the fraction area change (FAC), and the global longitudinal strain (GLS). The sphericity index (SI) and the fractional shortening (FS) of 24 segments were analyzed to identify any changes of fetal heart morphology and systolic function. The normal range of Z value was set at −2 to 2. Results Fetal BAL, TW, A, and gestational age (GA) were positively linearly correlated, while GSI, GLS, and FAC had no significant correlation with GA. There was no significant difference in fetal BAL, TW, A, GLS, and FAC between the two groups (P>0.05). There was no significant difference in the FS of the 24 segments of the left and right ventricles between the two groups (P>0.05). There was no significant difference in the SI of the 1-24 segments of the right ventricle between the two groups (P>0.05). The difference in fetal GSI between the two groups was statistically significant (P<0.05). There was no significant difference in SI between the 1–22 segments of the left ventricle between the two groups (P>0.05), but there was a statistically significant difference between the 23–24 segments (P<0.05). Conclusions The fetal HQ analysis technology can quickly and simply quantitatively assess the size, shape, and contractility of the fetal heart. Anemia in pregnant women has no significant effect on fetal heart size and systolic function; it only affects the morphology of the heart, showing that the heart tends to be spherical as a whole and some segments of the apical segment of the left ventricle are abnormal.