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

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. Identifier: NCT00466128
Recruitment Status : Unknown
Verified March 2015 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : April 27, 2007
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
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 or disease Intervention/treatment Phase
Preterm Premature Rupture of Membranes Drug: indomethacin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2007
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Intervention Details:
  • Drug: indomethacin
    Indomethacin 50mg PO followed by 25mg PO q6hrs

Primary Outcome Measures :
  1. Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Prolongation of pregnancy for 7 days [ Time Frame: 7 days ]
  2. 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 ]
  3. Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section [ Time Frame: from admission ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00466128

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Contact: Jolene S Seibel-Seamon, MD 215-955-9239
Contact: Jason Baxter, MD, MSCP 215-955-9238

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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jolene S Seibel-Seamon, MD    215-955-6293   
Principal Investigator: Jolene S Seibel-Seamon, MD         
Sponsors and Collaborators
Thomas Jefferson University
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Principal Investigator: Jolene S Seibel-Seamon, MD Thomas Jefferson University
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Responsible Party: Thomas Jefferson University Identifier: NCT00466128    
Other Study ID Numbers: 06U.528
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Thomas Jefferson University:
fetal membranes, preterm rupture
preterm rupture
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action