Comparison the efficacy of vaginal progesterone versus 17-alpha-hydroxyprogesterone caproate to prevent preterm birth in high-risk pregnant women undergo cerclage: a randomized clinical trial

Abstract

Objective

The aim of this study was to compare the effect of vaginal progesterone with 17-alpha-hydroxyprogesterone caproate (17OHP-C) in prevention of preterm birth in high-risk pregnant women undergo cerclage.

Materials and methods

This prospective randomized clinical trial registered in the Iranian Registry of Clinical Trials (IRCT20181107041585N4), was performed from May 2017 to August 2018 in Bandar Abbas, Iran. Fifty-eight eligible women who were scheduled for cervical cerclage due to a history of two or more previous preterm birth <28 weeks or a cervical length less than 25 mm with at least one previous preterm birth <34 weeks were randomly divided into two groups. The first group received 200 mg of vaginal progesterone suppository daily and the second one received 250 mg of 17OHP-C intramuscular weekly after cerclage procedure until the end of 36 weeks. Patients were followed up to the end of delivery and the newborn until the first 28 d after delivery.

Results

Gestational age at the time of birth in 17OHP-C group was significantly higher than vaginal progesterone group (p=.021). However, the incidence of preterm birth in both groups was not statistically significant (20.7% vs. 24.1%). Apgar scores, newborn birthweight, admission to neonatal intensive care unit (NICU), incidence of respiratory distress syndrome (RDS), sepsis, necrotizing enterocolitis (NEC), and, intraventricular hemorrhage (IVH), was similar in both groups. Adverse events were reported in 48.3% of patients in 17-OHP-C group, and 27.6% of patients in the vaginal progesterone group (p= .014).

Conclusions

Vaginal progesterone and 17OHP-C had similar results in terms of prevention of preterm birth and neonatal outcome. However, the adverse events associated with 17-OHP-C were higher than vaginal progesterone.

Keywords:

• 17-Alpha-hydroxyprogesterone caproat
• cerclage
• preterm birth
• vaginal progesterone[AQ]

Disclosure of interest

The authors report no conflicts of interest in this study.

Additional information

Funding

This study was supported by Hormozgan University of Medical Sciences, Islamic Republic of Iran.