Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor

Phase 4 Completed 129 enrolled HaEmek Medical Center, Israel

RandomizedParallel-groupOpen-labelTreatment

Summary

Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.

Timeline

Start: 2018-12-19
Primary completion: 2023-02-27
Completion: 2023-02-27

Outcome

Missed primary endpoint

paper VMP given in a dosage of 200 mg twice a day following APTL is not an effective treatment to prolong pregnancy or prevent SPTD. PMID 38976270 ↗

paper there was no difference in pregnancy prolongation (mean [SD], 40.0 [17.8] vs 37.4 [20.3] days; P = .44) PMID 38976270 ↗

Publications

Nachum Z, Ganor Paz Y, Massalha M, Wated M, Harel N, Yefet E. Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419894. doi: 10.1001/jamanetworkopen.2024.19894.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Progesterone	Other / unclassified	200 mg	Other

Indications

No indication recorded.