NCT00466128

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

8 years

First QC Date

April 25, 2007

Last Update Submit

March 17, 2015

Conditions

Preterm Premature Rupture of Membranes

Keywords

fetal membranes, preterm rupturepreterm rupturePPROM

Outcome Measures

Primary Outcomes (1)

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

    48 hours

Secondary Outcomes (3)

  • Prolongation of pregnancy for 7 days

    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)

    from admission/birth

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

    from admission

Interventions

indomethacinDRUG

Indomethacin 50mg PO followed by 25mg PO q6hrs

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35947046DERIVED

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jolene S Seibel-Seamon, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolene S Seibel-Seamon, MD

CONTACT

215-955-9239joleneseibel@yahoo.com

Jason Baxter, MD, MSCP

CONTACT

215-955-9238jkb105@jefferson.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2015

Study Completion

April 1, 2016

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)