Can the Use of a Next Generation Partograph Based on WHO's Latest Intrapartum Care Recommendations Improve Neonatal Outcomes? a Stepped-wedge Cluster Randomized Trial (PICRINO)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120,000
- Locations
- 24
- Primary Endpoint
- The rate of intrapartum cesarean section
Study Overview
Brief Summary
The overall aim is to evaluate the impact of the use of two different guidelines for monitoring labor progress, the WHOs LCG versus standard care, on neonatal and maternal outcomes. The hypothesis is that the use of LCG will reduce adverse neonatal outcomes and decrease the number of intrapartum Cesarean sections compared with standard care.
Secondly, other perinatal interventions and complications will be compared between the LCG and standard care groups, as well as economic considerations. This will be investigated using a multicenter, stepped-wedge cluster randomized trial design.
In addition, the project will explore a series of quantitative and qualitative research questions to gain in-depth knowledge about experiences and perceptions about childbirth and the use of LCG. These research questions will be investigated using questionnaires, focus group and individual interviews with providers, partners and women that have gone through childbirth.
Detailed Description
Study Title
Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? A stepped-wedge cluster randomized trial (PICRINO).
Primary Objectives
To compare two different guidelines for monitoring labor progress, the the World Health Organization (WHO)'s Labour Care Guide (LCG) with standard care, and evaluate:
Adverse neonatal outcome, a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score <7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All women in active labor
Exclusion Criteria
- •No exclusion criteria
Outcomes
Primary Outcomes
The rate of intrapartum cesarean section
Time Frame: 12 weeks up to 18 months
The rate of intrapartum cesarean section
Adverse neonatal outcome
Time Frame: 12 weeks up to 18 months
a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score \<7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.
Secondary Outcomes
- Neonatal outcomes(12 weeks up to 18 months)
- Obstetric outcomes(12 weeks up to 18 months)
- Childbirth experience (women and partners)(12 weeks up to 18 months)
- Economic evaluation(12 weeks up to 18 months)
- Provider experience of LCG(12 weeks up to 18 months)
Investigators
Marie Blomberg
Professor
Linkoeping University