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Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)
This study is currently recruiting participants.
Study NCT00466128   Information provided by Thomas Jefferson University
First Received: April 25, 2007   Last Updated: May 29, 2008   History of Changes

April 25, 2007
May 29, 2008
April 2007
April 2010   (final data collection date for primary outcome measure)
Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours
Complete list of historical versions of study NCT00466128 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Prolongation of pregnancy for 7 days
  • Maternal Morbidities: chorioamnionitis, endometritis, placental abruption, cesarean section, labor induction
  • Neonatal Morbidities: birth weight, APGAR scores, sepsis, respiratory distress syndrome (RDS), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), NICU hospitalization days, patent ductus arteriosus (PDA)
 
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

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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Preterm Premature Rupture of Membranes
Drug: indomethacin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
116
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
15 Years to 50 Years
Yes
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
 
NCT00466128
Jolene Seibel-Seamon, Thomas Jefferson University
06U.528
Thomas Jefferson University
 
Principal Investigator: Jolene S Seibel-Seamon, MD Thomas Jefferson University
Thomas Jefferson University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP