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Completed

NCT Number: NCT07686419

Labor Care Guide Application

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.

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Key information

Conditions

Labor Comfort

Age range

15 month–45 month

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

labor care guide

Device

labor monitoring tool

Primary outcomes

  1. Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)

    Time frame: assessed at 6 months

    Measured using a 5-point Likert scale. Range: 1-5. Higher scores indicate greater satisfaction.

Secondary outcomes

  1. Mode of delivery

    Time frame: At delivery

    The percentage of participants undergoing different modes of delivery (e.g., normal vaginal delivery, operative vaginal delivery, or cesarean section)

  2. Duration of active labor

    Time frame: At delivery

    The total duration of the active phase of labor, measured in hours.

  3. Incidence of maternal complications

    Time frame: assessed at 6 weeks postpartum

    The percentage of mothers who experience any postpartum or intrapartum complications (e.g., postpartum hemorrhage, infection).

  4. Incidence of neonatal complications

    Time frame: At delivery

    The percentage of newborns who experience neonatal complications (e.g., respiratory distress, hypoglycemia).

  5. Duration of hospital stay

    Time frame: from birth until hospital discharge average 2 to 3 days

    The total number of days the mother and/or neonate remained hospitalized from admission to discharge.

  6. Neonatal Outcomes via Apgar Score and NICU Admission

    Time frame: from birth until hospital discharge average 2 to 3 days

    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).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: LCG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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