Safety, Tolerability, and Pregnancy Outcomes Following Gravibinan Administration in Women at Risk of Miscarriage: A Multi-institutional Retrospective Study

TL;DR

This study examines the safety and effectiveness of Gravibinan in preventing miscarriage in high-risk pregnancies, finding it generally safe with few side effects.

Contribution

The study provides real-world clinical data on Gravibinan's safety and tolerability in high-risk pregnancies.

Findings

Gravibinan was well-tolerated with mostly mild side effects like injection site pain and nausea.

Fetal outcomes were favorable, with normal birth weights and Apgar scores.

Most women had satisfactory postpartum health and reproductive outcomes.

Abstract

Objective

Gravibinan is commonly used to prevent or manage miscarriage in high-risk pregnancies. However, data on its safety profile in real-world clinical settings remains limited. Hence, this study aimed to evaluate the safety and tolerability of Gravibinan in pregnant women at risk of miscarriage (two or more consecutive pregnancy losses) before the 20th week of gestation.

Methodology

This retrospective observational study was conducted in multiple tertiary care settings to assess the safety profile of Gravibinan in pregnant women. The study duration was about five months from January 2025 to May 2025. The inclusion criteria for the study were pregnant women between the ages of 18 and 45 years who had received a minimum of one dose of Gravibinan during their current pregnancy. The demographic details, such as age, height, weight, body mass index (BMI), and gestational age at enrollment, were documented. Cases with a history of miscarriage were included in the study. Gravibinan was administered intramuscularly at a dose of either 1 ml or 2 ml, initiated between the 5th and 7th week of gestation in patients with a history of recurrent miscarriage. Treatment was continued once or twice weekly until the end of the first trimester. Additionally, immediate local reactions along with any systemic side effects, were also recorded.

Results

Out of 534 pregnant women, the mean age of participants was 30.72 ± 5.90 years, with a mean gestational age of 13.55 ± 11.40 weeks at the time of enrollment. The majority, 408 (76.4%), received a 2 ml dose weekly. Local side effects like pain at the injection site at 214 (40.1%) and redness at 86 (16.1%) were mostly mild. Systemic side effects included nausea at 130 (24.3%), dizziness at 58 (10.9%), and vomiting at 70 (13.1%), with very few cases of serious symptoms like respiratory distress or vaginal bleeding at 8 (1.5%) each. Fetal outcomes were favorable, with a mean birth weight of 4.60 ± 1.74 pounds and an average Apgar score of 7.07 ± 1.03. Most women, 530 (99.3%), had normal postpartum health and satisfactory reproductive health in follow-up.

Conclusion

Gravibinan seems to be safe and well-tolerated in pregnant women at risk of miscarriage, with minimal adverse effects and positive maternal and fetal outcomes. Statistically significant associations were found between dosage and side effects such as injection site pain, swelling, dizziness, and nausea.