Status:
UNKNOWN
Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)
Lead Sponsor:
Thomas Jefferson University
Conditions:
Preterm Premature Rupture of Membranes
Eligibility:
FEMALE
15-50 years
Phase:
PHASE2
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 membran...
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 underst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00466128
Start Date
April 1 2007
End Date
April 1 2016
Last Update
March 18 2015
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107