Labor and Delivery
Conditions
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 .
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
OTHERGroup 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 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.
OTHERGroup 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 partographic findings.
Sponsors
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention, blinding of care providers and participants is not feasible.
Intervention model description
Participants will be randomly assigned to either the Labour Care Guide group or the WHO modified partograph group.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of labour | From admission in active labour until delivery | Total duration of labour measured from admission in active labour to delivery (in hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | )At the time of delivery | Mode of delivery categorized as spontaneous vaginal delivery, operative vaginal delivery, or caesarean section |
| Neonatal condition at birth | At birth and within 5 min after delivery | Assessed by apgar score at 1 and 5 min and need for neonatal resuscitation |
| Neonatal intensive care unit admission (NICU) | Within 24 hours after birth | Admission to NICU for any indication |
| Intrapartum maternal complications | During labour and immediate portpartum period | Occurrence of postpartum hemorrhage ,uterine rupture ,fetal distress |
Countries
Pakistan
Contacts
CONTACTDr Roshni Mumtaz, MBBS
Outcome results
None listed