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

Primary Purpose

Preterm Premature Rupture of Membranes

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

indomethacin

About this trial

This is an interventional treatment trial for Preterm Premature Rupture of Membranes focused on measuring fetal membranes, preterm rupture, preterm rupture, PPROM

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleAccepts 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

Sites / Locations

Thomas Jefferson University HospitalRecruiting

Outcomes

Primary Outcome Measures

Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours

Secondary Outcome Measures

Prolongation of pregnancy for 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)

Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section

Full Information

NCT ID

NCT00466128

First Posted

April 25, 2007

Last Updated

March 17, 2015

Sponsor

Thomas Jefferson University

1. Study Identification

Unique Protocol Identification Number

NCT00466128

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Premature Rupture of Membranes

Keywords

fetal membranes, preterm rupture, preterm rupture, PPROM

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

indomethacin

Intervention Description

Indomethacin 50mg PO followed by 25mg PO q6hrs

Primary Outcome Measure Information:

Title

Prolongation of pregnancy (interval from time of randomization to time of delivery) for 48 hours

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Prolongation of pregnancy for 7 days

Time Frame

7 days

Title

Time Frame

from admission/birth

Title

Maternal outcomes: chorioamnionitis, endometritis, labor induction, placental abruption, cesarean section

Time Frame

from admission

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jolene S Seibel-Seamon, MD

Phone

215-955-9239

joleneseibel@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jason Baxter, MD, MSCP

Phone

215-955-9238

jkb105@jefferson.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jolene S Seibel-Seamon, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jolene S Seibel-Seamon, MD

Phone

215-955-6293

joleneseibel@yahoo.com

First Name & Middle Initial & Last Name & Degree

Jolene S Seibel-Seamon, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

35947046

Citation

Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

Results Reference

derived

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

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