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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01050647
Recruitment Status : Active, not recruiting
First Posted : January 15, 2010
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Delivery at 34 weeks gestation [ Time Frame: Delivery ]

Secondary Outcome Measures :
  1. Neonatal respiratory distress syndrome [ Time Frame: Neonatal discharge ]
  2. Neonatal grade III - IV IVH [ Time Frame: Neonatal discharge ]
  3. Neonatal Necrotizing Enterocolitis [ Time Frame: Neonatal discharge ]
  4. Neonatal length of NICU and total hospital stay [ Time Frame: Neonatal discharge ]
  5. Length of latency [ Time Frame: Delivery ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050647

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

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 ( Other Identifier: Stanford University Medical Center )
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pregnancy Complications
Wounds and Injuries
17-alpha-hydroxy-progesterone caproate
Castor Oil
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Gastrointestinal Agents