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

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Indomethacin

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