Latest1 information on COVID-19
©2022 Stanford Medicine
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
Not Recruiting
Trial ID: NCT01050647
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.
Stanford Investigator(s)
Yasser El-Sayed, Professor
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery
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
Intervention(s):
other: Caster Oil injections
drug: 17-Hydroxyprogesterone Caproate
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cynthia Willson, RN
650-724-6372