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

Official title

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

Overview

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 .

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.

Interventions

• Other Group A (Intervention Arm): Monitoring with WHO Labour Care Guide)
  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 Mate
• Other Group B (Control Arm): Monitoring with Standard WHO Partograph)
  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

Primary outcome measures

• Duration of labour [Time frame: From admission in active labour until delivery]

Secondary outcome measures (4)

• Mode of delivery [Time frame: )At the time of delivery]
• Neonatal condition at birth [Time frame: At birth and within 5 min after delivery]
• Neonatal intensive care unit admission (NICU) [Time frame: Within 24 hours after birth]
• Intrapartum maternal complications [Time frame: During labour and immediate portpartum period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Khyber teacher hospital — Peshawar

Publications

• 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
• 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
• 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
• 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
• 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 PMID 38291297
• 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
• 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 Worl PMID 33225484
• 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

Identifiers

NCT: NCT07445373 · 549/DME/KMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗