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NCT Number: NCT07445373

Role of the WHO Labour Care Guide in Improving Maternal and Fetal Outcomes

The goal of this randomized controlled trial is to compare the effectiveness of WHO labour care guide (LCG) with the WHO modified partogragh in improving the maternal and fetal outcomes among primigravida and multigravida in active labour .the study evaluates whether use of the Labour care guide leads to improved labour monitoring ,timely clinical decision making and better maternal and neonatal outcomes .this study will answer either of the two questions that is

* There is no difference in maternal and fetal outcomes between women monitored with Wo labour care guide (LCG) and those monitored with the Modified Partogragh * There is a difference in maternal and fetal outcomes between women monitored with the WHO Labour care guide (LCG) and those monitored the modified Partogragh .

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Key information

Conditions

Labor and Delivery

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Khyber teacher hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

The WHO labour care guide is newer tool to designed in 2020 to replace the replace the traditional modified partogragh for monitoring labor and to improve the quality of intrapartum care .It focuses on evidence based and respectful maternity care and clinical decision making .This trial will b conducted in a tertiary care hospital (KTH Peshawar ) and will include women in active labor who meet the criteria .

The participant who are eligible will be randomly allocated in to two groups : one will be monitored using the WHO labour Care guide and the other monitored using modified Partogragh .maternal outcomes such as duration of labour ,mode of delivery ,need for labor augmentation and maternal complications will be assessed.Fetal and neonatal outcomes including Apgar score, need for neonatal resuscitation ,need for NICU admission ,and perinatal morbidity will also be assessed..

The study will aim to determine whether the Labour care guide provide superior clinical outcomes compared to the modified partogragh in both primigravida and multigravida women.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient aged 20 to 40 years .
  • gestational age 37 to 42 weeks as per LMP.
  • parity UpTo 4
  • singketon pregnancy on ultrasound
  • patient presenating In labor as per operational definitons

Exclusion criteria

  • patients with breech presenation
  • pregnant women in whom trial of labor given outside the hospital,
  • women with complications like gestational diabetes,antepartum hemorrhage,severe preeclampsia/eclampsia and medical disorders complicating the pregnancy
  • premature rupture of membranes

Treatment and study plan

Group A (Intervention Arm): Monitoring with WHO Labour Care Guide)

Other

Group A (Intervention Arm): Monitoring with WHO Labour Care Guide) Women randomized to Group A will be monitored using the World Health Organization Labour Care Guide (LCG) as the intrapartum monitoring tool.

The LCG incorporates evidence-based, individualized labour progress thresholds and emphasizes comprehensive maternal and fetal assessment. The following parameters will be recorded at recommended intervals:

Cervical dilatation and labour progress Fetal heart rate Uterine contractions Maternal vital signs (pulse, blood pressure, temperature) Assessment of amniotic fluid Supportive care measures (oral intake, mobility, pain relief) Respectful maternity care indicators Clinical reassessment prompts embedded within the LCG will guide decision-making. No traditional alert or action lines will be used; instead, management will be individualized based on dynamic clinical assessment.

Group B (Control Arm): Monitoring with Standard WHO Partograph)

Other

Women randomized to Group B will be monitored using the standard WHO-modified partograph as the intrapartum monitoring tool.

The partograph will include:

Cervical dilatation plotted against time Fetal heart rate monitoring Uterine contractions Maternal vital signs Status of membranes and liquor Labour progress will be assessed using the traditional alert and action lines, and clinical decisions (augmentation or operative intervention) will be taken according to institutional protocol based on partographic findings.

Primary outcomes

  1. Duration of labour

    Time frame: From admission in active labour until delivery

    Total duration of labour measured from admission in active labour to delivery (in hours)

Secondary outcomes

  1. Mode of delivery

    Time frame: )At the time of delivery

    Mode of delivery categorized as spontaneous vaginal delivery, operative vaginal delivery, or caesarean section

  2. Neonatal condition at birth

    Time frame: At birth and within 5 min after delivery

    Assessed by apgar score at 1 and 5 min and need for neonatal resuscitation

  3. Neonatal intensive care unit admission (NICU)

    Time frame: Within 24 hours after birth

    Admission to NICU for any indication

  4. Intrapartum maternal complications

    Time frame: During labour and immediate portpartum period

    Occurrence of postpartum hemorrhage ,uterine rupture ,fetal distress

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Roshni Mumtaz, MBBS

CONTACT

[email protected]

+923333765884

Sponsors and collaborators

Lead sponsor

Khyber Teaching Hospital

Other

Registry information

Official study title

Role of WHO Labour Care Guide in Improving Maternal and Fetal Outcomes in Primi and Multigravida in Labour

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Mar 3, 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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