- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466128
Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)
A Double-blinded Randomized Controlled Trial With Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM) Between 24 and 32 Weeks Gestation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preterm premature rupture of membranes (PPROM) is defined as rupture of the chorioamniotic membranes before the onset of labor prior to 37 weeks of gestation. The etiology of PPROM is not well understood but likely to be multifactorial. Although the underlying mechanism of PPROM is unknown, some speculate it is the human's inflammatory response to bacterial infection with the subsequent production of prostaglandins which weaken the fetal membranes. Therefore, the use of indomethacin, a prostaglandin inhibitor, may decrease prostaglandin synthesis leading to less uterine irritability and prevention of weakened membranes.
This is a double blind randomized controlled trial comparing indomethacin to placebo in women with PPROM between the gestational ages of 24-32 weeks. Women between the gestational age of 24 to 32 weeks with premature rupture of membranes and not in active labor will be eligible for this clinical trial. After informed consent, patients will be randomized to either indomethacin or placebo. Maternal and neonatal outcomes will be assessed.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jolene S Seibel-Seamon, MD
- Phone Number: 215-955-9239
- Email: joleneseibel@yahoo.com
Study Contact Backup
- Name: Jason Baxter, MD, MSCP
- Phone Number: 215-955-9238
- Email: jkb105@jefferson.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University Hospital
-
Contact:
- Jolene S Seibel-Seamon, MD
- Phone Number: 215-955-6293
- Email: joleneseibel@yahoo.com
-
Principal Investigator:
- Jolene S Seibel-Seamon, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gestational age between 24 0/7 - 31 5/7 weeks by LMP or ultrasound
- Documentation of rupture by demonstrating pooling or 2/3 diagnostic tests (pooling, ferning and nitrazine positivity)
Exclusion Criteria:
- Membrane rupture greater than 72 hours
- Persistent labor characterized by regular painful contractions with cervical change and/or cervix visually greater than 5 cm
- Chorioamnionitis defined by having 2 or more of the following: maternal temperature > 100.4, persistent fetal tachycardia (>170bpm), maternal tachycardia (>110bpm) in the absence of other likely cause, uterine tenderness.
- Non-reassuring fetal heart rate tracing or biophysical testing
- Vaginal hemorrhage
- Lethal fetal anomalies
- Intrauterine fetal demise
- Maternal conditions which precludes expectant management
- Fetal condition which precludes expectant management
- Maternal allergy to indomethacin
- Maternal active gastritis
- Multiple gestations
- HIV with viral load >1000
- HSV with active herpetic lesions
- Cervical cerclage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prolongation of pregnancy for 7 days
Time Frame: 7 days
|
7 days
|
Neonatal Morbidities: birth weight, APGAR scores, sepsis, respiratory distress syndrome (RDS), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), NICU hospitalization days, patent ductus arteriosus (PDA)
Time Frame: from admission/birth
|
from admission/birth
|
Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section
Time Frame: from admission
|
from admission
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jolene S Seibel-Seamon, MD, Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Rupture
- Premature Birth
- Fetal Membranes, Premature Rupture
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- 06U.528
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.
Clinical Trials on Preterm Premature Rupture of Membranes
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Erzincan Military HospitalCompletedPreterm Premature Rupture of MembranesTurkey
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Woman'sRecruitingPreterm Birth | Preterm Labor | Rupture of Membranes; Premature | Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture) | Rupture of Membranes; Premature, Affecting Fetus | Preterm PROM (Pregnancy)United States
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University of PennsylvaniaCompletedWomen Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)United States
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Assiut UniversityUnknownPreterm Pre-labor Rupture of MembranesEgypt
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