Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

Trial ID or NCT#

NCT01050647

Status

not recruiting iconNOT RECRUITING

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

Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. 18yr of age 2. Singleton pregnancy 3. PPROM confirmed on clinical exam 4. GA between 24+0 and 33+5 wk 5. Ability to understand consent in either English or Spanish
Exclusion Criteria:
  1. 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 diagnosis 2. Major fetal malformation 3. Maternal allergy to progesterone or placebo drug components 4. Current use of progesterone at the time of P-PROM 5. Multiple Gestations 6. Inability to understand consent in either English or Spanish
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Investigator(s)

Yasser El-Sayed, Professor
Yasser El-Sayed, Professor
Obstetrician and Gynecologist (OB-GYN)
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery

Contact us to find out if this trial is right for you.

Contact

Cynthia Willson, RN
650-724-6372

View on ClinicalTrials.gov