Labor Care Guide Application | NCT07686419

Studies
Labor Care Guide Application

NCT07686419

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jul 7, 2026Actual

Enrollment

350Actual

Phase

Not Applicable

Conditions

Labor Comfort

Interventions

labor care guide

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

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

Apr 1, 2025Actual

Primary Completion Date

Aug 1, 2025Actual

Completion Date

Aug 1, 2025Actual

First Submitted Date

Jun 10, 2026

First Submission Date that Met QC Criteria

Jun 29, 2026

First Posted Date

Jul 7, 2026Actual

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

Jun 29, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Application of the WHO Labor Care Guide in Ain Shams university Maternity hospital demonstrates high healthcare provider acceptability and improves labor progression, increases vaginal delivery rates, and reduces selected maternal complications without adversely affecting neonatal outcomes.

Detailed Description

The Labor Care Guide (LCG) is a tool developed by the World Health Organization (WHO) to support evidence-based, woman-centered intrapartum care and improve labor monitoring. It was introduced as an alternative to the traditional partograph, aiming to facilitate timely clinical decision-making and enhance the quality of maternity care.

This randomized controlled trial was conducted at Ain Shams University Maternity Hospital to evaluate the effect of the WHO Labor Care Guide on maternal and neonatal outcomes among women undergoing vaginal delivery. Eligible pregnant women were randomly assigned to one of two groups: a study group monitored using the WHO Labor Care Guide and a control group monitored using the modified WHO partograph.

Participants underwent routine obstetric assessment and monitoring throughout labor according to the allocated monitoring tool. Maternal outcomes assessed included labor progression, mode of delivery, and intrapartum and postpartum complications. Neonatal outcomes included neonatal well-being, need for neonatal intensive care admission, and neonatal complications. Healthcare provider satisfaction with the labor monitoring tool was also evaluated.

The study aimed to compare the effectiveness of the WHO Labor Care Guide with the modified WHO partograph in supporting labor management and improving maternal and neonatal care.

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

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Labor care guide	Experimental	Intervensional study	Device: labor care guide
partogrph	No Intervention	no intervension

Interventions

Name	Type	Description	Arm Group Labels	Other Names
labor care guide	Device	labor monitoring tool	Labor care guide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)	Measured using a 5-point Likert scale. Range: 1-5. Higher scores indicate greater satisfaction.	assessed at 6 months

Secondary Outcomes

Measure	Description	Time Frame
Mode of delivery	The percentage of participants undergoing different modes of delivery (e.g., normal vaginal delivery, operative vaginal delivery, or cesarean section)	At delivery
Duration of active labor

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant woman who will undergo vaginal delivery at Ain Shams University Maternity Hospital with gestational age above or equal 37 weeks
Vertex presentation .
Women with estimated fetal weight 2.5 till 4 kg

Exclusion Criteria::

Placenta previa
Placenta previa accreta
Macrosomic baby above 4 kg in diabetic women and above 4.5 kg in non diabetic women
Placenta abruption complicated by non reassuring CTG or life threatening bleeding
Cord prolapse
Vasa previa
Primary active genital herpes simplex
Patient with anemia which may lead to atonic uterus and prolonged labor.
Women with previously scarred uterus due to risk of ruptured uterus and postpartum hemorrhage

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Months

Maximum Age

45 Months

Standard Ages

Child

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
Ain Shams University Maternity Hospital		Cairo			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

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Labor care guide application	Mar 1, 2025	Jun 22, 2026	Prot_000.pdf
Prot	Yes	No	No	Study Protocol: Labor care guide application in Ain Shams university	Mar 1, 2025	Jun 10, 2026	Prot_001.pdf