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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)
Led by Linkoeping University · Updated on 2024-10-22
120000
Participants Needed
24
Research Sites
104 weeks
Total Duration
On this page
Sponsors
L
Linkoeping University
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organization's Labour Care Guide (LCG) with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHO's LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers' compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.
CONDITIONS
Brief Title
Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All women in active labor
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of active labor
Participants receive labor monitoring according to either the WHO Labour Care Guide or standard delivery care in Sweden during active labor.
1 labor and delivery visit (in-person)
Duration - 12 weeks up to 18 months
Participants and their newborns are followed for up to 18 months to assess neonatal and obstetric outcomes, childbirth experience, provider experience, and economic evaluation.
Multiple follow-up visits over 12 weeks to 18 months
Trial Site Locations
Total: 24 locations
1
Eksjö höglandssjukhuset
Eksjö, Sweden
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2
Falu Lasarett
Falun, Sweden
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3
Gällivare sjukhus
Gällivare, Sweden
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4
Göteborg Salgrenska Universitetssjukhuset
Gothenburg, Sweden
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5
Helsingborgs lasarett
Helsingborg, Sweden
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6
Huddinge Karolinska universitetssjukhus
Huddinge, Sweden
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7
Hudiksvalls sjukhus
Hudiksvall, Sweden
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8
Jönköping Länssjukhuset Ryhov
Jönköping, Sweden
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9
Länssjukhuset
Kalmar, Sweden
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10
Kristianstad centralsjukhus
Kristianstad, Sweden
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11
Linköpings universitetssjukhus
Linköping, Sweden
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12
Lund Skånes universitetssjukhus
Lund, Sweden
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13
Skellefteå Lasarett
Skellefteå, Sweden
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14
Södertälje Sjukhus
Södertälje, Sweden
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15
Sunderby sjukhus
Södra Sunderbyn, Sweden
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16
BB Stockholm
Stockholm, Sweden
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17
Stockholm Södersjukhuset
Stockholm, Sweden
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18
Umeå Norrlands universitetssjukhus
Umeå, Sweden
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19
Akademiska sjukhuset
Uppsala, Sweden
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20
Värnamo sjukhus
Värnamo, Sweden
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21
Västerviks sjukhus
Västervik, Sweden
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22
Visby Lasarett
Visby, Sweden
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23
Ystad Lasarett
Ystad, Sweden
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24
Vrinnevisjukhuset
Norrköping, Östergötland County, Sweden
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Research Team
M
Marie Blomberg, Professor
A
Anna Ramö Isgren, pHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation.
Joshua P Vogel, Liz Comrie-Thomson, Veronica Pingray...
https://pubmed.ncbi.nlm.nih.gov/33225484Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? (PICRINO) Study protocol for a stepped-wedge cluster randomized trial.
Anna Ramö Isgren, Radha Korsoski, Thomas Abrahamsson...
https://pubmed.ncbi.nlm.nih.gov/40036215