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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pregnancy Complications

In brief

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).

Key facts

Study ID

NCT01050647

Run by

Stanford University

People needed

21

Starts

2010-02-01

Expected to finish

2015-12-01

Last updated by the study team

2019-04-09

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 18yr of age
• Singleton pregnancy
• PPROM confirmed on clinical exam
• GA between 24+0 and 33+5 wk
• Ability to understand consent in either English or Spanish

You may not qualify if…

• Contraindication to ongoing pregnancy including:
• Evidence of active infection
• Evidence of significant placental abruption
• IUFD diagnosed at the time of P-PROM diagnosis
• Major fetal malformation
• Maternal allergy to progesterone or placebo drug components
• Current use of progesterone at the time of P-PROM
• Multiple Gestations
• Inability to understand consent in either English or Spanish

Where it is running

• Santa Clara Valley Medical Center — San Jose, California, United States
• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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