NCT03491826

Brief Summary

The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,011

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

4.9 years

First QC Date

March 28, 2018

Last Update Submit

April 6, 2018

Conditions

Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

  • maternal mortality

    maternal mortality

    up to 48 hours after delivery

Study Arms (2)

ROM before 34 weeks (A)

premature rupture of membrane before 34 weeks

Biological: rupture of membrane

ROM after 34 weeks (B)

premature rupture of membrane after 34 weeks

Biological: rupture of membrane

Interventions

rupture of membraneBIOLOGICAL
ROM after 34 weeks (B)ROM before 34 weeks (A)

Eligibility Criteria

Age24 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant female with history of rupture membrane

You may qualify if:

  • rupture of membrane

You may not qualify if:

  • medical disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 9, 2018

Study Start

January 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 9, 2018

Record last verified: 2018-04

Locations

EG(1)