Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00466128
First received: April 25, 2007
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 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: 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prolongation of pregnancy for 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section [ Time Frame: from admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: April 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: indomethacin
    Indomethacin 50mg PO followed by 25mg PO q6hrs
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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466128

Contacts
Contact: Jolene S Seibel-Seamon, MD 215-955-9239 joleneseibel@yahoo.com
Contact: Jason Baxter, MD, MSCP 215-955-9238 jkb105@jefferson.edu

Locations
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         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Jolene S Seibel-Seamon, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00466128     History of Changes
Other Study ID Numbers: 06U.528
Study First Received: April 25, 2007
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
fetal membranes, preterm rupture
preterm rupture
PPROM

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cardiovascular Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014