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

• ClinicalTrials.gov Identifier: NCT01050647
• Recruitment Status: Completed
• First Posted: January 15, 2010
• Results First Posted: April 17, 2018
• Last Update Posted: April 9, 2019
• Sponsor: Stanford University
• Information provided by (Responsible Party): Yasser Yehia El-Sayed, Stanford University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pregnancy Complications	Drug: 17-Hydroxyprogesterone Caproate; Other: Caster Oil injections	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
• Study Start Date: February 2010
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 17-hydroxyprogesterone caproate; Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation	Drug: 17-Hydroxyprogesterone Caproate; Weekly injections of 17-hydroxyprogesterone caproate.; Other Name: Active study drug
Placebo Comparator: Castor oil injections; Weekly injections of Caster Oil (placebo)	Other: Caster Oil injections; Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Achievement of 34 Weeks Gestation [ Time Frame: From enrollment until delivery, an average of 34 weeks ]
   Delayed delivery until 34 weeks gestation.

Secondary Outcome Measures :

1. Number of Participants With Neonatal Respiratory Distress Syndrome [ Time Frame: From delivery until neonatal hospital discharge, assessed up to 2 months ]
2. Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage [ Time Frame: From delivery until neonatal hospital discharge, assessed up to 2 months ]
3. Number of Participants With Neonatal Necrotizing Enterocolitis [ Time Frame: From delivery to neonatal discharge, assessed up to 2 months ]
4. Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days [ Time Frame: From birth to discharge form delivery hospital, assessed up to 2 months ]
5. Length of Latency Assessed as Number of Days [ Time Frame: From rupture of membranes until delivery, assessed up to 34 weeks of gestation ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Santa Clara Valley Medical Center

San Jose, California, United States, 95128

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Yasser Y El-Sayed, MD; Stanford University

More Information

• Responsible Party: Yasser Yehia El-Sayed, Professor of Obstetrics and Gynecology, Stanford University
• ClinicalTrials.gov Identifier: NCT01050647
• Other Study ID Numbers: SU-01082010-4683; 17976 ( Other Identifier: Stanford University Medical Center )
• First Posted: January 15, 2010
• Results First Posted: April 17, 2018
• Last Update Posted: April 9, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Pregnancy Complications; Rupture; Wounds and Injuries; Castor Oil; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Progestins; Hormones; Cathartics; Gastrointestinal Agents