This trial is active, not recruiting.

Condition pregnancy complications
Treatments 17-hydroxyprogesterone caproate, caster oil injections
Phase phase 1/phase 2
Sponsor Stanford University
Start date February 2010
End date October 2016
Trial size 40 participants
Trial identifier NCT01050647, 17976, SU-01082010-4683


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation
17-hydroxyprogesterone caproate Active study drug
Weekly injections of 17-hydroxyprogesterone caproate.
(Placebo Comparator)
Weekly injections of Caster Oil (placebo)
caster oil injections Placebo
Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Primary Outcomes

Delivery at 34 weeks gestation
time frame: Delivery

Secondary Outcomes

Neonatal respiratory distress syndrome
time frame: Neonatal discharge
Neonatal grade III - IV IVH
time frame: Neonatal discharge
Neonatal Necrotizing Enterocolitis
time frame: Neonatal discharge
Neonatal length of NICU and total hospital stay
time frame: Neonatal discharge
Length of latency
time frame: Delivery

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
Principal investigator Yasser Y El-Sayed, MD
Description When women present to either the Obstetrical clinic or labor and delivery with a complaint of possible preterm, premature rupture of membranes (PPROM), they will be examined by an obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM, they will then be admitted to Lucile Packard Children's Hospital and treated with the normal protocol which includes receiving antibiotics, receiving steroids, being hospitalized until delivery, and having ongoing maternal and fetal monitoring for possible complications. The patients will be identified by their treating obstetricians as possible study candidates and asked by a member of the treatment team if they are potentially interested in participating in a research study. Subsequently, a member of the study team or the treating physician will approach the patient about participating in the trial. Those who choose to participate will receive the standard care protocol in addition to receiving the study medication. The study medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or placebo. The placebo medication (castor oil) was chosen as it has been used in previous studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the patient receives will be determined by a randomization table. Only the pharmacist will be aware of the medication that has been administered. The patient, members of the treatment team, and members of the study team will be blinded to the medication that is being administered. The timing of their delivery will be managed by the treating obstetrician according to standard medical practice. After delivery, the patient's and her infant's medical outcomes will be recorded for analysis.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Stanford University.