Comparative Study Between Using WHO Labour Care Guide & Modified WHO Partograph

Comparative Study Between Using WHO Labour Care Guide & Modified WHO Partograph in Reducing Primary Cesarean Section in Primiparous Women in Active First Stage of Labour.

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.

Study Overview

• Status: Completed
• Conditions: Labor Onset and Length Abnormalities; First Birth; 37 or More Completed Weeks of Gestation
• Intervention / Treatment: Other: LCG guided labour interference; Other: Supportive care measures

Detailed Description

A group of primiparous women in first stage of labour will be randomized into two groups then monitored during first stage of labour. First group will be monitored by modified WHO partograph. The rest of participants will be monitored by WHO labour care Guide. The labour will be monitored regarding progress rate, mode of delivery.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Old Cairo
    • Cairo, Old Cairo, Egypt, 11562
      • kasr Al Aini, Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Study Population

This randomized controlled study will be conducted on 230 low-risk pregnant women admitted in labor in the labor room (LR) in kasr Alainy hospital.

Enrollment at the time of admission as per inclusion and exclusion criteria. After informed consent, randomization and allocation to study and control groups will be conducted using a computer- generated sequence, and enrollment continues until the desired sample size of 115 is reached in each group.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WHO labour care guide	Other: LCG guided labour interference; LCG as a new tool to make proper decision and management of first stage of labour
Active Comparator: Modified WHO partograph	Other: Supportive care measures; traditional partograph to properly manage first stage of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hend Mahmoud Abdelghany

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: primiparous; labour Monitoring
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: MD-400-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No