Is Misoprostol Vaginal Insert Safe for the Induction of Labor in High-Risk Pregnancy Obese Women?

Valentin Nicolae Varlas; Georgiana Bostan; Bogdana Adriana Nasui; Nicolae Bacalbasa; Anca Lucia Pop

doi:10.3390/healthcare9040464

Is Misoprostol Vaginal Insert Safe for the Induction of Labor in High-Risk Pregnancy Obese Women?

Healthcare (Basel). 2021 Apr 14;9(4):464. doi: 10.3390/healthcare9040464.

Authors

Valentin Nicolae Varlas^{1

2}, Georgiana Bostan³, Bogdana Adriana Nasui⁴, Nicolae Bacalbasa², Anca Lucia Pop⁵

Affiliations

¹ Department of Obstetrics and Gynecology, Filantropia Clinical Hospital, 011132 Bucharest, Romania.
² Department of Obstetrics and Gynecology, Carol Davila University of Medicine and Pharmacy, 37 Dionisie Lupu St., 020021 Bucharest, Romania.
³ County Emergency Hospital St. John the New, 720224 Suceava, Romania.
⁴ Department of Community Health, Iuliu Hațieganu University of Medicine and Pharmacy, 6 Louis Pasteur Street,400349 Cluj-Napoca, Romania.
⁵ Department of Clinical Laboratory, Food Safety, Carol Davila University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania.

Abstract

Induction of labor (IOL) is an event that occurs in up to 25% of pregnancies. In Europe, the misoprostol vaginal insert (MVI-Misodel^®) was approved for labor induction in 2013. Studies on the outcomes and safety of IOL in obese pregnant women are scarce; no data are available on MVI IOL in high-risk pregnancy obese women (HRPO-late-term, hypertension, diabetes). As the obesity rates are growing steadily in pregnant women, we aimed to evaluate the failure rate for induction and the safety of a 200 μg MVI in obese (body mass index (BMI) >30 kg/m²) HRPO compared to that for obese non-high-risk pregnancies (non-HRPO). For this purpose, we conducted a cross-sectional study in "Filantropia" Clinical Hospital, Bucharest, Romania, from June 2017-the date of the initiation of the MVI IOL protocol in our clinic-to September 2019. The primary outcomes were the failure rate, measured by cesarean section (CS) ratio, and secondarily, the safety profile of MVI, analyzed by one-way ANOVA. Out of a total of 11,096 registered live births, IOL was performed on 206 obese patients. Of these, 74 obese pregnant women had their labor induced with MVI (HRPO, n = 57, and non-HRPO, n = 17). The average maternal age was 29.9 ± 4.8 years (19-44 years). Across the groups, the rate of CS was 29.8% (n = 17) in the HRPO group compared to 23.5% (n = 4) in the non-HRPO group (p = non significant). In the vaginally birth subgroups, the median time from drug administration to delivery was shorter in the HRPO group compared to the non-HRPO group (16.9 ± 6.0 h 95% confidence interval (CI) 15.0-18.8 vs. 19.4 ± 9.2 h 95% CI 13.8-25.0, p = 0.03). No significant differences were found regarding the maternal outcomes among the studied groups; in terms of perinatal outcomes of safety, 5.4% (n = 4) of the cases of vaginal delivery for HRPO were associated with neonatal intensive care unit (NICU) admissions. The MVI seems to be an efficient labor induction agent in high-risk pregnancy obese women with good maternal outcomes and low perinatologic complications.

Keywords: induction of labor; misoprostol vaginal insert; obesity; pregnancy.