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

NCT ID: NCT01050647

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2015-12-31

Brief 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).

Detailed 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.

Conditions

Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

17-hydroxyprogesterone caproate

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

Group Type: ACTIVE_COMPARATOR

17-Hydroxyprogesterone Caproate

Intervention Type: DRUG

Weekly injections of 17-hydroxyprogesterone caproate.

Castor oil injections

Weekly injections of Caster Oil (placebo)

Group Type: PLACEBO_COMPARATOR

Caster Oil injections

Intervention Type: OTHER

Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Interventions

17-Hydroxyprogesterone Caproate

Weekly injections of 17-hydroxyprogesterone caproate.

Intervention Type: DRUG

Caster Oil injections

Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Intervention Type: OTHER

Other Intervention Names

Active study drug; Placebo

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Yasser Yehia El-Sayed

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasser Y El-Sayed, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Santa Clara Valley Medical Center

San Jose, California, United States

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

17976

Identifier Type: OTHER

Identifier Source: secondary_id

SU-01082010-4683

Identifier Type: -

Identifier Source: org_study_id