TerminatedNot Applicable

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

Stopped: Low enrollment rate

United States38 participantsStarted 2013-05

Plain-language summary

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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Number of Participants Who Delivered Before 37 Weeks'

Timeframe: Duration of current pregnancy, anticipated maximum 18 weeks

Trial details

NCT IDNCT01840228

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-07

Results submitted2019-05-07