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/33225484/Actively Recruiting
Led by Linkoeping University · Updated on 2024-10-22
120000
Participants Needed
24
Research Sites
104 weeks
Total Duration
Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations 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 WHOs 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
Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)
M
Marie Blomberg, Professor
A
Anna Ramö Isgren, pHD
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Linkoeping University
Lead Sponsor
The Swedish Research Council
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Joshua P Vogel, Liz Comrie-Thomson, Veronica Pingray...
https://pubmed.ncbi.nlm.nih.gov/33225484/Anna Ramö Isgren, Radha Korsoski, Thomas Abrahamsson...
https://pubmed.ncbi.nlm.nih.gov/40036215/Linkoeping University
Lead Sponsor
The Swedish Research Council
Collaborating Sponsor