Comparative Study Between Using WHO Labour Care Guide & M... | NCT06537089

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

NCT06537089

Sponsor

Hend Mahmoud Abdelghany

Status

Completed

Last Update Posted

Feb 23, 2026Actual

Enrollment

230Actual

Phase

Not Applicable

Conditions

Labor Onset and Length Abnormalities
37 or More Completed Weeks of Gestation
First Birth

Interventions

Supportive care measures
LCG guided labour interference

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

Feb 2026

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

Aug 1, 2024Actual

Primary Completion Date

Dec 30, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Jul 31, 2024

First Submission Date that Met QC Criteria

Jul 31, 2024

First Posted Date

Aug 5, 2024Actual

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

Feb 19, 2026

Last Update Posted Date

Feb 23, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hend Mahmoud Abdelghany, Lecturer of Obstetrics and Gynecology, Cairo University, Kasr El Aini HospitalSponsor-Investigator

Lead Sponsor

Hend Mahmoud AbdelghanyOTHER

Collaborators

Not provided

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

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.

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.

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

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WHO labour care guide	Active Comparator		Other: LCG guided labour interference
Modified WHO partograph	Active Comparator		Other: Supportive care measures

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supportive care measures	Other	traditional partograph to properly manage first stage of labor	Modified WHO partograph

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 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
kasr Al Aini, Faculty of Medicine, Cairo University		Cairo	Old Cairo	11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided