Fetal and Maternal Outcome in Preterm Premature Rupture o... | NCT03491826

Studies
Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)

NCT03491826

Sponsor

sarah mohamed hassan

Status

Completed

Last Update Posted

Apr 9, 2018Actual

Enrollment

1,011Actual

Phase

Not provided

Conditions

Premature Rupture of Membrane

Interventions

rupture of membrane

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 28, 2018

First Submission Date that Met QC Criteria

Apr 6, 2018

First Posted Date

Apr 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2018

Last Update Posted Date

Apr 9, 2018Actual

Name	Class
Hend Mostafa Hussein Salem	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The data will be retrieved from the archival files and analyzed

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,011Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
rupture of membrane	Biological		ROM after 34 weeks (B) ROM before 34 weeks (A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maternal mortality	maternal mortality	up to 48 hours after delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

rupture of membrane

Exclusion Criteria:

medical disorder

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

pregnant female with history of rupture membrane

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr El Ainiy Hospital		Cairo		11562	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005322	Fetal Membranes, Premature Rupture

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided