Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial

Phase 3 Completed 250 enrolled King's College Hospital NHS Trust

RandomizedFactorialDouble-blindPrevention

Summary

The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.

Timeline

Start: 2003-09
Primary completion: —
Completion: 2006-11

Outcome

Met primary endpoint

paper Spontaneous delivery before 34 weeks of gestation was less frequent in the progesterone group than in the placebo group (19.2% vs. 34.4%; relative risk, 0.56; PMID 17671254 ↗

paper 95% confidence interval [CI], 0.36 to 0.86). PMID 17671254 ↗

Publications

Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Micronised progesterone	Unknown	200 mg	Other

Indications

No indication recorded.