Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)
Status unconfirmed · Phase 2
Conditions studied: Preterm Premature Rupture of Membranes
In brief
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.
Key facts
- Study ID
- NCT00466128
- Run by
- Thomas Jefferson University
- People needed
- 116
- Starts
- 2007-04-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2015-03-18
Who can join
Age: 15 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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