- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01050647
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
April 2, 2019 updated by: Yasser Yehia El-Sayed, Stanford University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
21
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Jose, California, United States, 95128
- Santa Clara Valley Medical Center
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18yr of age
- Singleton pregnancy
- PPROM confirmed on clinical exam
- GA between 24+0 and 33+5 wk
- Ability to understand consent in either English or Spanish
Exclusion Criteria:
Contraindication to ongoing pregnancy including:
- Evidence of active infection
- Evidence of significant placental abruption
- IUFD diagnosed at the time of P-PROM diagnosis
- Major fetal malformation
- Maternal allergy to progesterone or placebo drug components
- Current use of progesterone at the time of P-PROM
- Multiple Gestations
- Inability to understand consent in either English or Spanish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 17-hydroxyprogesterone caproate
Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation
|
Weekly injections of 17-hydroxyprogesterone caproate.
Other Names:
|
PLACEBO_COMPARATOR: Castor oil injections
Weekly injections of Caster Oil (placebo)
|
Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From enrollment until delivery, an average of 34 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Neonatal Respiratory Distress Syndrome
Time Frame: From delivery until neonatal hospital discharge, assessed up to 2 months
|
From delivery until neonatal hospital discharge, assessed up to 2 months
|
Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage
Time Frame: From delivery until neonatal hospital discharge, assessed up to 2 months
|
From delivery until neonatal hospital discharge, assessed up to 2 months
|
Number of Participants With Neonatal Necrotizing Enterocolitis
Time Frame: From delivery to neonatal discharge, assessed up to 2 months
|
From delivery to neonatal discharge, assessed up to 2 months
|
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
|
From birth to discharge form delivery hospital, assessed up to 2 months
|
Length of Latency Assessed as Number of Days
Time Frame: From rupture of membranes until delivery, assessed up to 34 weeks of gestation
|
From rupture of membranes until delivery, assessed up to 34 weeks of gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
January 13, 2010
First Submitted That Met QC Criteria
January 14, 2010
First Posted (ESTIMATE)
January 15, 2010
Study Record Updates
Last Update Posted (ACTUAL)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Rupture
- Pregnancy Complications
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Cathartics
- Progestins
- 17 alpha-Hydroxyprogesterone Caproate
- 11-hydroxyprogesterone
- Castor Oil
Other Study ID Numbers
- SU-01082010-4683
- 17976 (OTHER: Stanford University Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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