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

NCT07445373 | Not Yet Recruiting

• 1 other identifier: 549/DME/KMC
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Labor and Delivery

Outcome Measures

Primary Outcomes (1)

• Duration of labour

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

  From admission in active labour until delivery

Secondary Outcomes (4)

• Mode of delivery

  )At the time of delivery

• Neonatal condition at birth

  At birth and within 5 min after delivery

• Neonatal intensive care unit admission (NICU)

  Within 24 hours after birth

• Intrapartum maternal complications

  During labour and immediate portpartum period

Study Arms (2)

Group A

EXPERIMENTAL

Group A will be monitored using the WHO Labour Care Guide (LCG) for Intrapartum assessment and clinical decision-making from the active phase of labour until delivery.

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

Group B

ACTIVE COMPARATOR

group B will be monitored using the WHO Modified Partograph for documentation and assessment of labor progress, maternal condition, and fetal well-being until delivery.

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

Interventions

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 A

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.

Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: The study includes pregnant women in active labour; therefore, only female participants are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber teacher hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (8)

• Tolu LB, Jeldu WG, Feyissa GT. Effectiveness of utilizing the WHO safe childbirth checklist on improving essential childbirth practices and maternal and perinatal outcome: A systematic review and meta-analysis. PLoS One. 2020 Jun 12;15(6):e0234320. doi: 10.1371/journal.pone.0234320. eCollection 2020.

  PMID: 32530940 BACKGROUND

• Sama CB, Takah NF, Danwe VK, Melo UF, Dingana TN, Angwafo FF 3rd. Knowledge and utilization of the partograph: A cross-sectional survey among obstetric care providers in urban referral public health institutions in northwest and southwest Cameroon. PLoS One. 2017 Feb 24;12(2):e0172860. doi: 10.1371/journal.pone.0172860. eCollection 2017.

  PMID: 28234990 BACKGROUND

• Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.

  PMID: 28681500 BACKGROUND

• Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8(8):CD005461. doi: 10.1002/14651858.CD005461.pub5.

  PMID: 30080256 BACKGROUND

• Vogel JP, Pujar Y, Vernekar SS, Armari E, Pingray V, Althabe F, Gibbons L, Berrueta M, Somannavar M, Ciganda A, Rodriguez R, Bendigeri S, Kumar JA, Patil SB, Karinagannanavar A, Anteen RR, Mallappa Ramachandrappa P, Shetty S, Bommanal L, Haralahalli Mallesh M, Gaddi SS, Chikkagowdra S, Raghavendra B, Homer CSE, Lavender T, Kushtagi P, Hofmeyr GJ, Derman R, Goudar S. Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial. Nat Med. 2024 Feb;30(2):463-469. doi: 10.1038/s41591-023-02751-4. Epub 2024 Jan 30.

  PMID: 38291297 BACKGROUND

• Pandey D, Bharti R, Dabral A, Khanam Z. Impact of WHO Labor Care Guide on reducing cesarean sections at a tertiary center: an open-label randomized controlled trial. AJOG Glob Rep. 2022 Jul 20;2(3):100075. doi: 10.1016/j.xagr.2022.100075. eCollection 2022 Aug.

  PMID: 36276791 BACKGROUND

• Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Birth. 2021 Mar;48(1):66-75. doi: 10.1111/birt.12511. Epub 2020 Nov 22.

  PMID: 33225484 BACKGROUND

• Maaloe N, van Roosmalen J, Dmello B, Kwast B, van den Akker T, Housseine N, Kujabi M, Meguid T, Kidanto H. WHO next-generation partograph: revolutionary steps towards individualised labour care? BJOG. 2022 Apr;129(5):682-684. doi: 10.1111/1471-0528.16914. Epub 2021 Sep 28. No abstract available.

  PMID: 34520112 BACKGROUND

Central Study Contacts

Dr Roshni Mumtaz, MBBS

CONTACT

+923333765884; roshnimumtaz1234@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of care providers and participants is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Training medical officer(i-e 2nd year resident )

Model Details: Participants will be randomly assigned to either the Labour Care Guide group or the WHO modified partograph group.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)