Labor Care Guide Application (LCG)

Labor Care Guide Application in Ain Shams University Maternity Hospital: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Labor Comfort
• Intervention / Treatment: Device: labor care guide

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria::

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Labor care guide; Intervensional study	Device: labor care guide; labor monitoring tool
No Intervention: partogrph; no intervension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	The total duration of the active phase of labor, measured in hours.	At delivery
Incidence of maternal complications	The percentage of mothers who experience any postpartum or intrapartum complications (e.g., postpartum hemorrhage, infection).	assessed at 6 weeks postpartum
Incidence of neonatal complications	The percentage of newborns who experience neonatal complications (e.g., respiratory distress, hypoglycemia).	At delivery
Duration of hospital stay	The total number of days the mother and/or neonate remained hospitalized from admission to discharge.	from birth until hospital discharge average 2 to 3 days
Neonatal Outcomes via Apgar Score and NICU Admission	Neonatal well-being will be assessed using the Apgar score at 5 minutes (ranging from 0 to 10, where higher scores indicate better neonatal health) and the rate of admission to the Neonatal Intensive Care Unit (NICU).	from birth until hospital discharge average 2 to 3 days

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: labor care guide
• Other Study ID Numbers: MS459

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