Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 15 - 50 |
| Updated: | 4/2/2016 |
| Start Date: | April 2007 |
| End Date: | April 2016 |
| Contact: | Jolene S Seibel-Seamon, MD |
| Email: | joleneseibel@yahoo.com |
| Phone: | 215-955-9239 |
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.
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.
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.
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
We found this trial at
1
site
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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