- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445373
Role of the WHO Labour Care Guide in Improving Maternal and Fetal Outcomes
Role of WHO Labour Care Guide in Improving Maternal and Fetal Outcomes in Primi and Multigravida in Labour
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 .
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr Roshni Mumtaz, MBBS
- Phone Number: +923333765884
- Email: roshnimumtaz1234@gmail.com
Study Locations
-
-
Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Khyber teacher hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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.
|
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. |
|
Active Comparator: Group B
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
From admission in active labour until delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mode of delivery
Time Frame: )At the time of delivery
|
Mode of delivery categorized as spontaneous vaginal delivery, operative vaginal delivery, or caesarean section
|
)At the time of delivery
|
|
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
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At birth and within 5 min after delivery
|
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Neonatal intensive care unit admission (NICU)
Time Frame: Within 24 hours after birth
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Admission to NICU for any indication
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Within 24 hours after birth
|
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Intrapartum maternal complications
Time Frame: During labour and immediate portpartum period
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Occurrence of postpartum hemorrhage ,uterine rupture ,fetal distress
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During labour and immediate portpartum period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 549/DME/KMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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