Vaginal Progesterone on the Prevention of Preterm Birth and Neonatal Complications in High Risk Women: A Randomized Placebo-controlled Double-blind Study

Overview

Journal Int J Reprod Biomed

Specialty Reproductive Medicine

Date 2016 Jun 22

PMID 27326415

Citations 14

Authors

Azam Azargoon

Raheb Ghorbani

Fereshteh Aslebahar

Affiliations

Soon will be listed here.

Abstract

Background: Preterm birth is the major cause of neonatal mortality and morbidity.

Objective: The aim of this study was to evaluate the effect of prophylactic vaginal progesterone on decreasing preterm birth rate and neonatal complications in a high-risk population.

Materials And Methods: A randomized, double-blind, placebo-controlled study was performed on 100 high-risk singleton pregnancies. Vaginal suppository progesterone (400 mg) or placebo was administered daily between 16-22 wks to 36 wks of gestation. Progesterone (n=50) and placebo (n=50) groups were compared for incidence of preterm delivery and neonatal complications.

Results: The preterm birth rate was 52%. Preterm birth rate before the 37 wks of gestation (68% vs. 36%: RR=1.89, 95% CI: 1.25-2.86) and also before the 34 wks of gestation (42% vs. 18%: RR=2.33, 95% CI: 1.19-4.58) in placebo group was significantly higher than progesterone group. Our study also showed that the administration of vaginal progesterone was associated with a significant reduction in the risk of birth weight ≤2500 gr, the rates of respiratory distress syndrome (RDS) and admission to the Neonatal Intensive Care Unit (NICU) in the progesterone group when compared with the placebo group. However, there was no significant difference between the two groups in terms of neonatal death, days of admission in NICU, intraventricular hemorrhage and necrotizing enterocolitis.

Conclusion: Prophylactic vaginal progesterone reduced the rate of preterm delivery, the risk of a birth weight ≤2500 gr, the rates of RDS and admission to NICU in women who were at risk of preterm delivery.

Citing Articles

Possible Efficacy of Vaginal Progesterone on Asymptomatic Women with a Short Cervix after 24 Weeks of Gestation: A Historical Cohort Study in Japan.

Otsuka N, Imai K, Tano S, Matsuo S, Ushida T, Nomoto M JMA J. 2024; 7(4):582-589.

PMID: 39513065 PMC: 11543341. DOI: 10.31662/jmaj.2024-0036.

Effects of vaginal progesterone and placebo on preterm birth and antenatal outcomes in women with singleton pregnancies and short cervix on ultrasound: a meta-analysis.

Peng L, Gao Y, Yuan C, Kuang H Front Med (Lausanne). 2024; 11:1328014.

PMID: 38646553 PMC: 11026645. DOI: 10.3389/fmed.2024.1328014.

Progesterone, cerclage, pessary, or acetylsalicylic acid for prevention of preterm birth in singleton and multifetal pregnancies - A systematic review and meta-analyses.

Wennerholm U, Bergman L, Kuusela P, Ljungstrom E, Moller A, Hongslo Vala C Front Med (Lausanne). 2023; 10:1111315.

PMID: 36936217 PMC: 10015499. DOI: 10.3389/fmed.2023.1111315.

Vaginal progesterone for the prevention of preterm birth: who can benefit and who cannot? Evidence-based recommendations for clinical use.

Conde-Agudelo A, Romero R J Perinat Med. 2022; 51(1):125-134.

PMID: 36475431 PMC: 9837386. DOI: 10.1515/jpm-2022-0462.

Does vaginal progesterone prevent recurrent preterm birth in women with a singleton gestation and a history of spontaneous preterm birth? Evidence from a systematic review and meta-analysis.

Conde-Agudelo A, Romero R Am J Obstet Gynecol. 2022; 227(3):440-461.e2.

PMID: 35460628 PMC: 9420758. DOI: 10.1016/j.ajog.2022.04.023.

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