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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate; Castor Oil; Progesterone

Criteria

Inclusion Criteria:

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. 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