Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorLinkoeping University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
WHOs Labour care guide
Other interventionGuidelines for monitoring labor progress, the WHOs LCG
Treatment groups
120,000 Participants
are divided into 2 treatment groupsGroup A: Labour care guideExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 weeks up to 18 months2
The rate of intrapartum cesarean section
The rate of intrapartum cesarean section
Time frame
12 weeks up to 18 monthsSecondary outcomes
1
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
Time frame
12 weeks up to 18 months2
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
Time frame
12 weeks up to 18 months3
Childbirth experience (women and partners)
interviews questionaries
Time frame
12 weeks up to 18 months4
Provider experience of LCG
interviews
Time frame
12 weeks up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Linkoeping University
Lead sponsor
The Swedish Research Council
Collaborator
Source ClinicalTrials.gov