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Sponsored by: |
Thomas Jefferson University |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00466128 |
The purpose of this study is to determine if the short term use of indomethacin will reduce the number of women delivering within 48 hours when given to women with preterm premature rupture of membranes (PPROM) between 24- 32 weeks of gestation. We hypothesize that indomethacin's anti-inflammatory and tocolytic action will reduce the number of women delivering within 48 hours when given to women with PPROM between 24-32 weeks of gestation.
Condition | Intervention | Phase |
---|---|---|
Preterm Premature Rupture of Membranes |
Drug: indomethacin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 116 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 15 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jolene S Seibel-Seamon, MD | 215-955-9239 | joleneseibel@yahoo.com |
Contact: Jason Baxter, MD, MSCP | 215-955-9238 | jkb105@jefferson.edu |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Jolene S Seibel-Seamon, MD 215-955-6293 joleneseibel@yahoo.com | |
Principal Investigator: Jolene S Seibel-Seamon, MD |
Principal Investigator: | Jolene S Seibel-Seamon, MD | Thomas Jefferson University |
Responsible Party: | Thomas Jefferson University ( Jolene Seibel-Seamon ) |
Study ID Numbers: | 06U.528 |
Study First Received: | April 25, 2007 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00466128 History of Changes |
Health Authority: | United States: Institutional Review Board |
fetal membranes, preterm rupture preterm rupture PPROM |
Anti-Inflammatory Agents Pregnancy Complications Cyclooxygenase Inhibitors Obstetric Labor Complications Wounds and Injuries Rupture Disorders of Environmental Origin Cardiovascular Agents |
Fetal Membranes, Premature Rupture Analgesics, Non-Narcotic Indomethacin Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Pregnancy Complications Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disorders of Environmental Origin Reproductive Control Agents Fetal Membranes, Premature Rupture Gout Suppressants Tocolytic Agents Sensory System Agents Therapeutic Uses Indomethacin Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Cyclooxygenase Inhibitors Wounds and Injuries Obstetric Labor Complications Rupture Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |