Actively Recruiting

Phase Not Applicable
FEMALE
ID05560802

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

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • All women in active labor
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

Actively Recruiting

2

Falu Lasarett

Falun, Sweden

Actively Recruiting

3

Gällivare sjukhus

Gällivare, Sweden

Actively Recruiting

4

Göteborg Salgrenska Universitetssjukhuset

Gothenburg, Sweden

Actively Recruiting

5

Helsingborgs lasarett

Helsingborg, Sweden

Actively Recruiting

6

Huddinge Karolinska universitetssjukhus

Huddinge, Sweden

Actively Recruiting

7

Hudiksvalls sjukhus

Hudiksvall, Sweden

Actively Recruiting

8

Jönköping Länssjukhuset Ryhov

Jönköping, Sweden

Actively Recruiting

9

Länssjukhuset

Kalmar, Sweden

Actively Recruiting

10

Kristianstad centralsjukhus

Kristianstad, Sweden

Actively Recruiting

11

Linköpings universitetssjukhus

Linköping, Sweden

Actively Recruiting

12

Lund Skånes universitetssjukhus

Lund, Sweden

Actively Recruiting

13

Skellefteå Lasarett

Skellefteå, Sweden

Actively Recruiting

14

Södertälje Sjukhus

Södertälje, Sweden

Actively Recruiting

15

Sunderby sjukhus

Södra Sunderbyn, Sweden

Actively Recruiting

16

BB Stockholm

Stockholm, Sweden

Actively Recruiting

17

Stockholm Södersjukhuset

Stockholm, Sweden

Actively Recruiting

18

Umeå Norrlands universitetssjukhus

Umeå, Sweden

Actively Recruiting

19

Akademiska sjukhuset

Uppsala, Sweden

Actively Recruiting

20

Värnamo sjukhus

Värnamo, Sweden

Actively Recruiting

21

Västerviks sjukhus

Västervik, Sweden

Actively Recruiting

22

Visby Lasarett

Visby, Sweden

Actively Recruiting

23

Ystad Lasarett

Ystad, Sweden

Actively Recruiting

24

Vrinnevisjukhuset

Norrköping, Östergötland County, Sweden

Actively Recruiting

Loading map...

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

Similar Trials

Prevention of Metabolic Acidosis in Preterm Neonates by Repl...

Metabolic Acidosis

Actively Recruiting

1 location

Impact of Scheduled Positioning Using a Peanut Birthing Ball...

Labor (Obstetrics)--Complications

Actively Recruiting

1 location

The Norwegian World Health Organisation Labour Care Guide Tr...

Labor Dystocia

Actively Recruiting

10 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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/33225484

Can 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