NCT07686419

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
Last Updated

July 7, 2026

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

June 10, 2026

Last Update Submit

June 29, 2026

Conditions

Labor Comfort

Keywords

labor care guide

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Mode of delivery

    At delivery

  • Duration of active labor

    At delivery

  • Incidence of maternal complications

    assessed at 6 weeks postpartum

  • Incidence of neonatal complications

    At delivery

  • Duration of hospital stay

    from birth until hospital discharge average 2 to 3 days

  • +1 more secondary outcomes

Study Arms (2)

Labor care guide

EXPERIMENTAL

Intervensional study

Device: labor care guide

partogrph

NO INTERVENTION

no intervension

Interventions

labor care guideDEVICE

labor monitoring tool

Labor care guide

Eligibility Criteria

Age15 Months - 45 Months
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

July 7, 2026

Study Start

April 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 7, 2026

Record last verified: 2025-08

Locations

EG(1)