Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor

Stopped early · Not applicable · Has a placebo group

Conditions studied: Premature Birth, Obstetric Labor, Premature

In brief

Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. However, current use of this therapy is limited to certain high-risk groups including women with a history of preterm birth and women with a short cervix. This study seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women with arrested preterm labor. The investigators hypothesize that administration of vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours after cessation of short-term therapy to inhibit contractions will result in lower rates of preterm birth before 37 weeks' than will administration of placebo.

Key facts

Study ID

NCT01840228

Run by

Washington University School of Medicine

People needed

38

Starts

2013-05-01

Expected to finish

2018-05-07

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Singleton or twin gestation
• Estimated gestational age between 24 0/7 and 33 6/7 weeks' gestation
• Initially present with regular contractions and clinical diagnosis of preterm labor but remain undelivered with 1) no further cervical change 12 hours after discontinuation of acute tocolytic therapy; or 2) be considered eligible for discharge based on attending physician judgment prior to the 12 hour period of time
• The participant's cervix must be at least 1 cm at the time of enrollment

You may not qualify if…

• Non-English speaking
• Rupture of membranes
• Chorioamnionitis
• Non-reassuring fetal status
• Maternal indication for delivery
• Placental abruption
• Intrauterine fetal demise
• Prenatally diagnosed major fetal anomaly
• Cervical cerclage in place
• Previous administration of progesterone during the current pregnancy for a history of preterm birth or short cervix
• Participant is either unwilling or unable to attend follow-up study visits following hospital discharge

Where it is running

• Washington University School of Medicine/ Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.