NCT06537089

Brief Summary

This randomized clinical trial is based on comparing the efficiency of modified WHO partographs vs. the new WHO labour care guide in monitoring and assessing the outcome of labour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

July 31, 2024

Last Update Submit

February 19, 2026

Conditions

Keywords

labour Monitoringprimiparous

Outcome Measures

Primary Outcomes (1)

  • Rate of primary caesarean section

    number of women will undergo Caesarean section after monitoring, whether by Modified WHO partograph or a labour care Guide

    First and second stage of labour

Secondary Outcomes (3)

  • Duration of active phase of first stage of labour

    First stage of labour

  • Duration of second stage of labour

    Second stage of labour

  • need for oxytocin use

    First stage of labour

Study Arms (2)

WHO labour care guide

ACTIVE COMPARATOR
Other: LCG guided labour interference

Modified WHO partograph

ACTIVE COMPARATOR
Other: Supportive care measures

Interventions

traditional partograph to properly manage first stage of labor

Modified WHO partograph

LCG as a new tool to make proper decision and management of first stage of labour

WHO labour care guide

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous women.
  • Term gestation between 37 and 40 weeks.
  • Maternal age from 18 -35 years
  • Body mass index BMI of 18.5 to 29.9 kg/m2
  • Cephalic presentation. 6. Active first stage of labour

You may not qualify if:

  • Women with any medical comorbidities, such as (hypertension, diabetes mellitus, renal disease, or pulmonary disease).
  • Women with presence of any obstetrical complications, such as preterm birth, multiple gestation, breech presentation, postdated pregnancy, or bad obstetrical history.
  • women who were given intrapartum epidural analgesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr Al Aini, Faculty of Medicine, Cairo University

Cairo, Old Cairo, 11562, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology, Cairo University

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

August 1, 2024

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations