Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)

Study Overview
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Brief Summary
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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
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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. The rate of intrapartum cesarean section. Secondary Objectives Secondary outcomes will be a composite of severe neonatal outcomes including five-minute Apgar score <4, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures and meconium aspiration syndrome and other relevant neonatal outcomes. Obstetric outcomes will be mode of delivery, oxytocin use, postpartum hemorrhage, perineal laceration (grade II-IV), duration of labor, women´s and partner´s experiences of childbirth, healthcare providers experiences of and compliance to LCG and economic considerations. Study Design A multicenter, stepped-wedge cluster randomized trial. Study Population All women in active labor at participating delivery units in Sweden. Power analysis With significance level 0.05, the power to detect the anticipated risk reduction (20%) would be >0.999. Study Duration 2023-2025

Official Title
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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)

Conditions
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Neonatal Complication, Labor (Obstetrics)--Complications

Intervention / Treatment
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* Other: WHOs Labour care guide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -All women in active labor Exclusion Criteria: -No exclusion criteria
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, stepped-wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Labour care guide<br>According to WHO guidelines | Other: WHOs Labour care guide<br>* Guidelines for monitoring labor progress, the WHOs LCG<br>|
| No Intervention: Standard care<br>Standard delivery care in Sweden | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks up to 18 months | 
| The rate of intrapartum cesarean section | The rate of intrapartum cesarean section | 12 weeks up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal outcomes | Five-minute Apgar score <7 admission to neonatal unit Hypoxic ischemic encephalopathy II-III Intracranial hemorrhage Neonatal seizures Meconium aspiration syndrome Five-minute Apgar score <4 Perinatal mortality neonatal mortality Neonatal infection Neonatal hypoglycemia Neonatal jaundice Shoulder dystocia Obstetric brachial plexus injury | 12 weeks up to 18 months | 
| Obstetric outcomes | Rates of spontaneous vaginal delivery Rates of instrumental delivery Indications for intrapartum cesarean section Rates of oxytocin use for augmentation of labor Cervical dilation at onset of augmentation (centimeters) Rates of adherence to oxytocin use recommendations Rates of epidural use Amount of postpartum bleeding, ml Rates of perineal laceration (grade II-IV) Duration of labor, minutes | 12 weeks up to 18 months | 
| Childbirth experience (women and partners) | interviews questionaries | 12 weeks up to 18 months | 
| Provider experience of LCG | interviews | 12 weeks up to 18 months | 
| Economic evaluation | Data on health care utilization for women Data on health care utilization for children | 12 weeks up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal outcomes, obstetric outcomes, labour care guide