NCT02714270

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

March 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

March 16, 2016

Last Update Submit

August 1, 2018

Conditions

Normal Labor

Outcome Measures

Primary Outcomes (1)

  • Duration of active phase of labor

    calculated in hours between cervical dilatation more than 3 cm till fully dilated

    12 hours

Study Arms (2)

modified partograph

ACTIVE COMPARATOR

routine modified partograph

Procedure: modified partograph

paperless partograph

ACTIVE COMPARATOR

paperless partograph with no graph paper

Procedure: paperless partograph

Interventions

modified partographPROCEDURE
modified partograph
paperless partographPROCEDURE
paperless partograph

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Malpresentation
  • Induced labour
  • Multiple pregnancy
  • Medical diseases with pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 21, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

August 2, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Locations

EG(1)