A Phase 2 interventional study of indomethacin in Preterm Premature Rupture of Membranes, sponsored by Thomas Jefferson University. Status unknown at 1 site in United States. Open to female participants aged 15 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Thomas Jefferson University · Phase 2, Interventional, and Treatment
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.
Thomas Jefferson University is the lead sponsor of 390 studies on the registry; 72 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
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Exclusion Criteria:
Indomethacin 50mg PO followed by 25mg PO q6hrs
Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours
Time frame: 48 hours
Prolongation of pregnancy for 7 days
Time frame: 7 days
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
Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section
Time frame: from admission
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indomethacin
Preterm Premature Rupture of the Membranes