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

Thomas Jefferson University

Status and phase

Unknown

Phase 2

Conditions

Preterm Premature Rupture of Membranes

Treatments

Drug: indomethacin

Study type

Interventional

Funder types

Other

Identifiers

NCT00466128

06U.528

Details and patient eligibility

About

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.

Full 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.

Enrollment

116 estimated patients

Sex

Female

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

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