| April 25, 2007 |
| May 29, 2008 |
| April 2007 |
| April 2010 (final data collection date for primary outcome measure) |
| Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ] |
| Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours |
| Complete list of historical versions of study NCT00466128 on ClinicalTrials.gov Archive Site |
- Prolongation of pregnancy for 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Neonatal Morbidities: birth weight, APGAR scores, sepsis, respiratory distress syndrome (RDS), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), NICU hospitalization days, patent ductus arteriosus (PDA) [ Time Frame: from admission/birth ] [ Designated as safety issue: No ]
- Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section [ Time Frame: from admission ] [ Designated as safety issue: No ]
|
- Prolongation of pregnancy for 7 days
- Maternal Morbidities: chorioamnionitis, endometritis, placental abruption, cesarean section, labor induction
- Neonatal Morbidities: birth weight, APGAR scores, sepsis, respiratory distress syndrome (RDS), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), NICU hospitalization days, patent ductus arteriosus (PDA)
|
| |
| Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM) |
| 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. |
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. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Preterm Premature Rupture of Membranes |
| Drug: indomethacin |
| |
| |
| |
| Recruiting |
| 116 |
| April 2010 |
| April 2010 (final data collection date for primary outcome measure) |
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
|
| Female |
| 15 Years to 50 Years |
| Yes |
|
|
| United States |
| |
| NCT00466128 |
| Jolene Seibel-Seamon, Thomas Jefferson University |
| 06U.528 |
| Thomas Jefferson University |
|
| Principal Investigator: |
Jolene S Seibel-Seamon, MD |
Thomas Jefferson University |
|
|
| Thomas Jefferson University |
| May 2008 |