Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Drug: 17-Hydroxyprogesterone Caproate
  • Other: Caster Oil injections

Phase:

Phase 1/Phase 2

Eligibility


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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cynthia Willson, RN
650-724-6372
Not Recruiting