Using a new labor monitoring guide to improve neonatal outcomes
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)
This study is testing if using a new labor monitoring guide can help improve health outcomes for mothers and their newborns during childbirth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120000 (estimated) |
| Sex | Female |
| Sponsor | Linkoeping University Government |
| Locations | 24 sites (Eksjö and 23 other locations) |
| Trial ID | NCT05560802 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of the World Health Organization's Labour Care Guide (LCG) compared to standard care on neonatal and maternal outcomes during labor. It employs a multicenter, stepped-wedge cluster randomized trial design to assess adverse neonatal outcomes, the rate of intrapartum cesarean sections, and other perinatal complications. Additionally, the study will gather qualitative data through questionnaires and interviews to understand the experiences of women and healthcare providers during childbirth. The aim is to determine if the LCG can lead to better health outcomes for mothers and newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are women in active labor at participating delivery units in Sweden.
Not a fit: Patients who are not in active labor or those delivering outside the participating units may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neonatal outcomes and reduced cesarean sections during labor.
How similar studies have performed: Other studies have shown promising results with similar labor monitoring approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -All women in active labor Exclusion Criteria: -No exclusion criteria
Where this trial is running
Eksjö and 23 other locations
- Eksjö höglandssjukhuset — Eksjö, Sweden (Recruiting)
- Falu Lasarett — Falun, Sweden (Recruiting)
- Gällivare sjukhus — Gällivare, Sweden (Recruiting)
- Göteborg Salgrenska Universitetssjukhuset — Gothenburg, Sweden (Recruiting)
- Helsingborgs lasarett — Helsingborg, Sweden (Recruiting)
- Huddinge Karolinska universitetssjukhus — Huddinge, Sweden (Recruiting)
- Hudiksvalls sjukhus — Hudiksvall, Sweden (Recruiting)
- Jönköping Länssjukhuset Ryhov — Jönköping, Sweden (Recruiting)
- Länssjukhuset — Kalmar, Sweden (Recruiting)
- Kristianstad centralsjukhus — Kristianstad, Sweden (Recruiting)
- Linköpings universitetssjukhus — Linköping, Sweden (Recruiting)
- Lund Skånes universitetssjukhus — Lund, Sweden (Recruiting)
- Skellefteå Lasarett — Skellefteå, Sweden (Recruiting)
- Södertälje Sjukhus — Södertälje, Sweden (Recruiting)
- Sunderby sjukhus — Södra Sunderbyn, Sweden (Recruiting)
- BB Stockholm — Stockholm, Sweden (Recruiting)
- Stockholm Södersjukhuset — Stockholm, Sweden (Recruiting)
- Umeå Norrlands universitetssjukhus — Umeå, Sweden (Recruiting)
- Akademiska sjukhuset — Uppsala, Sweden (Recruiting)
- Värnamo sjukhus — Värnamo, Sweden (Recruiting)
- Västerviks sjukhus — Västervik, Sweden (Recruiting)
- Visby Lasarett — Visby, Sweden (Recruiting)
- Ystad Lasarett — Ystad, Sweden (Recruiting)
- Vrinnevisjukhuset — Norrköping, Östergötland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Marie Blomberg, Professor — Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
- Study coordinator: Marie Blomberg, Professor
- Email: marie.blomberg@liu.se
- Phone: +4613288956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.