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

Preterm Premature Rupture of Membranes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00466128
• Other study ID #: 06U.528
• Status: Recruiting
• Phase: Phase 2
• First received: April 25, 2007
• Last updated: March 17, 2015
• Start date: April 2007
• Est. completion date: April 2016

Study information

• Verified date: March 2015
• Source: Thomas Jefferson University
• Contact: Jolene S Seibel-Seamon, MD
• Phone: 215-955-9239
• Email: joleneseibel[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membranes
• Rupture

Intervention

Drug:
• indomethacin
Indomethacin 50mg PO followed by 25mg PO q6hrs

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours		48 hours	No
Secondary	Prolongation of pregnancy for 7 days		7 days	No
Secondary	Neonatal Morbidities: birth weight, APGAR scores, sepsis, respiratory distress syndrome (RDS), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), NICU hospitalization days, patent ductus arteriosus (PDA)		from admission/birth	No
Secondary	Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section		from admission	No