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

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:
NCT01050647
First received: January 13, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Pregnancy Complications
 Drug: 17-Hydroxyprogesterone Caproate vs Castor oil (placebo)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Delivery at 34 weeks gestation [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neonatal respiratory distress syndrome [ Time Frame: Neonatal discharge ] [ Designated as safety issue: No ]
  • Neonatal grade III - IV IVH [ Time Frame: Neonatal discharge ] [ Designated as safety issue: No ]
  • Neonatal Necrotizing Enterocolitis [ Time Frame: Neonatal discharge ] [ Designated as safety issue: No ]
  • Neonatal length of NICU and total hospital stay [ Time Frame: Neonatal discharge ] [ Designated as safety issue: No ]
  • Length of latency [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 17-hydroxyprogesterone caproate Drug: 17-Hydroxyprogesterone Caproate vs Castor oil (placebo)

Weekly injections of 17-hydroxyprogesterone caproate.

Weekly infections of castor oil.
Placebo Comparator: Castor oil Drug: 17-Hydroxyprogesterone Caproate vs Castor oil (placebo)

Weekly injections of 17-hydroxyprogesterone caproate.

Weekly infections of castor oil.

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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050647

Contacts
Contact: Elizabeth S Langen, MD (650) 799-8784 elizabethlangen@stanford.edu

Locations
United States, California
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States
Contact: Anita Sit, M.D.     408-885-5550     Anita.Sit@hhs.sccgov.org    
Principal Investigator: Anita Sit, M.D.            
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Elizabeth S Langen, MD     650-799-8784     elizabethlangen@stanford.edu    
Contact: El-Sayed Y Yasser, MD     (650) 725-6823     hasser.el-sayed@stanford.edu    
Principal Investigator: Yasser Yehia El-Sayed            
Sub-Investigator: Elizabeth Suzanne Langen            
Sub-Investigator: Deirdre Judith Lyell            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Yasser Yehia El-Sayed Stanford University
  More Information

No publications provided

Responsible Party: Yasser Yehia El-Sayed, Professor of Obstetrics and Gynecology, Stanford University
ClinicalTrials.gov Identifier: NCT01050647     History of Changes
Other Study ID Numbers: SU-01082010-4683, 17976
Study First Received: January 13, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pregnancy Complications
Rupture
Wounds and Injuries
Castor Oil
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progesterone
Cathartics
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013