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

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050647
• Other study ID #: SU-01082010-4683
• Secondary ID: 17976
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Rupture

Intervention

Drug:
• 17-Hydroxyprogesterone Caproate
Weekly injections of 17-hydroxyprogesterone caproate.

Other:
• Caster Oil injections
Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Locations

Country	Name	City	State
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Achievement of 34 Weeks Gestation	Delayed delivery until 34 weeks gestation.	From enrollment until delivery, an average of 34 weeks
Secondary	Number of Participants With Neonatal Respiratory Distress Syndrome		From delivery until neonatal hospital discharge, assessed up to 2 months
Secondary	Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage		From delivery until neonatal hospital discharge, assessed up to 2 months
Secondary	Number of Participants With Neonatal Necrotizing Enterocolitis		From delivery to neonatal discharge, assessed up to 2 months
Secondary	Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days		From birth to discharge form delivery hospital, assessed up to 2 months
Secondary	Length of Latency Assessed as Number of Days		From rupture of membranes until delivery, assessed up to 34 weeks of gestation