NCT06420453

Brief Summary

"How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth. Today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. The World Health Organization partograph is a decision-making support tool designed to assist midwives in identifying normal labor duration and women at risk of developing complications. The tool guide the use of care interventions intended to mitigate any perceived risks. The partograph has been in use since the 1950ies and has had a profound impact on care and management during labor. Normal labor progression according to the partograph is a linear progression with cervical dilation of 1 centimeter per hour (alert line) and any deviation from this should lead to an intervention.The purpose of this research project is to increase person-centred care during labor. Specifically, we want to provide updated comprehensive information on labor duration and patient safety for reduction of; unnecessary medical interventions during normal labor; morbidity and mortality in the new-born; maternal complications during delivery and the puerperal period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

12.7 years

First QC Date

May 14, 2024

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adverse neonatal outcomes

    1 month postpartum

  • Adverse maternal outcomes

    1 month postpartum

Study Arms (2)

Exposed to prolonged labor duration

Not exposed to prolonged labor duration

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is an epidemiological research project using the largest cohort in the world containing detailed information on labor progression and care during labor. The cohort used is built from detailed data from medical records in the Stockholm-Gotland Obstetric Cohort, including all births from 2008 to 2020 (\> 300 000 births). This includes data from the partograph with information about start of labor, all cervical examinations, care interventions, total duration of labor, maternal and neonatal outcomes. For completeness of data on infant outcomes, the cohort has been linked with the Swedish Neonatal Quality Register (SNQ).

You may qualify if:

  • All births with labor duration

You may not qualify if:

  • Elective Cesarean birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Pregnancy ComplicationsObstetric Labor Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 20, 2024

Study Start

January 1, 2008

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations