Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
Trial ID or NCT#
Status
Purpose
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).
Official Title
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
Eligibility Criteria
- 1. 18yr of age2. Singleton pregnancy3. PPROM confirmed on clinical exam4. GA between 24+0 and 33+5 wk5. Ability to understand consent in either English or Spanish
- 1. Contraindication to ongoing pregnancy including:
- 1. Evidence of active infection 2. Evidence of significant placental abruption 3. IUFD diagnosed at the time of P-PROM diagnosis2. Major fetal malformation3. Maternal allergy to progesterone or placebo drug components4. Current use of progesterone at the time of P-PROM5. Multiple Gestations6. Inability to understand consent in either English or Spanish
Investigator(s)
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Contact
Cynthia Willson, RN
650-724-6372
View on ClinicalTrials.gov