Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)
- Conditions
- Neonatal ComplicationLabor (Obstetrics)--Complications
- Registration Number
- NCT05560802
- Lead Sponsor
- Linkoeping University
- 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.
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 120000
-All women in active labor
-No exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The rate of intrapartum cesarean section 12 weeks up to 18 months The rate of intrapartum cesarean section
Adverse neonatal outcome 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 Outcome Measures
Name Time Method Neonatal outcomes 12 weeks up to 18 months 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 injuryObstetric outcomes 12 weeks up to 18 months 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, minutesChildbirth experience (women and partners) 12 weeks up to 18 months interviews questionaries
Economic evaluation 12 weeks up to 18 months Data on health care utilization for women Data on health care utilization for children
Provider experience of LCG 12 weeks up to 18 months interviews
Trial Locations
- Locations (24)
Eksjö höglandssjukhuset
🇸🇪Eksjö, Sweden
Falu Lasarett
🇸🇪Falun, Sweden
Gällivare sjukhus
🇸🇪Gällivare, Sweden
Göteborg Salgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Helsingborgs lasarett
🇸🇪Helsingborg, Sweden
Huddinge Karolinska universitetssjukhus
🇸🇪Huddinge, Sweden
Hudiksvalls sjukhus
🇸🇪Hudiksvall, Sweden
Jönköping Länssjukhuset Ryhov
🇸🇪Jönköping, Sweden
Länssjukhuset
🇸🇪Kalmar, Sweden
Kristianstad centralsjukhus
🇸🇪Kristianstad, Sweden
Scroll for more (14 remaining)Eksjö höglandssjukhuset🇸🇪Eksjö, SwedenEmma LindqvistContact