Paperless Partograph for Management of Low Risk Labor | NCT02714270

Studies
Paperless Partograph for Management of Low Risk Labor

NCT02714270

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 2, 2018Actual

Enrollment

370Actual

Phase

Not Applicable

Conditions

Normal Labor

Interventions

modified partograph
paperless partograph

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

Aug 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

Dec 2016Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Mar 16, 2016

First Submission Date that Met QC Criteria

Mar 18, 2016

First Posted Date

Mar 21, 2016Estimated

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

Aug 1, 2018

Last Update Posted Date

Aug 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Paperless partograph is a technique used for monitoring the progress of labor before delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.

The study will be carried out to find out the effectiveness of paperless partograph in management of labor and its effect on maternal and neonatal outcomes

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

370Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
modified partograph	Active Comparator	routine modified partograph	Procedure: modified partograph
paperless partograph	Active Comparator	paperless partograph with no graph paper	Procedure: paperless partograph

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified partograph	Procedure		modified partograph
paperless partograph

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of active phase of labor	calculated in hours between cervical dilatation more than 3 cm till fully dilated	12 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age: 18 to 40 years
Gestational age 38-42 weeks
Singleton pregnancy
Vertex presentation
Women who will accept to participate in the study

Exclusion criteria:

Malpresentation
Induced labour
Multiple pregnancy
Medical diseases with pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided