NCT05979194

Brief Summary

The goal of this mixed method multisite effectiveness-implementation study across all basic and comprehensive emergency obstetric and newborn care facilities in Mbarara district and Mbarara City in Southwestern Uganda is to identify unique challenges, facilitators and patterns of potential and sustained uptake of the new WHO Labor Care Guide. Using these baseline findings, I will characterize, and refine the LCG, and then develop a suitable training strategy to effectively integrate/implement the new LCG into routine maternity care in Mbarara district. I will then utilize the Proctor implementation outcome framework to evaluate implementation outcomes of using the new labor care guide in routine maternity care that include; acceptability, appropriateness, feasibility, fidelity, and effectiveness among HCPs actively involved in deliveries across Mbarara District and Mbarara City. Finally, I will assess the diagnostic predictability of the new LCG compared to the partogram in effectively detecting prolonged labor among women delivering in Mbarara district and Mbarara City.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

July 30, 2023

Last Update Submit

July 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of women with prolonged labor

    We will define prolonged labor as 1) labor crossing the action line on the partograph, 2) labor lasting more than a specified centimeter cervical dilation "time lag" in the alert column of section 5 of the LCG

    6 months

Secondary Outcomes (1)

  • Proportion of obstetric interventions

    6months

Study Arms (1)

Labor care guide

OTHER

In this study, we shall determine the effectiveness and other implementation outcomes of the new LCG using Proctor implementation outcome framework among HCPs delivering women across Mbarara District and Mbarara City and evaluate the diagnostic accuracy of the new WHO LCG versus the partogram in detecting prolonged labour and reducing rates of obstructed labour among women delivering in Mbarara district. We shall use local contextualized data from qualitative one-on-one key informant interviews in objective 1 from HCPs and Ministry of Health official involved in labour monitoring and implementation. The WHO labour care guide shall be refined and a Ugandan Ministry of Health prototype designed. An appropriated training and implementation strategy informed by the HCPs themselves shall be used to deliver the content to HCPs in all pilot sites.

Behavioral: Labor Care Guide

Interventions

Identifying information and labor characteristics at admission, supportive care, care of the baby, care of the woman, labor progress, medication, and shared decision-making

Labor care guide

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with self-reported willingness to use the new LCG in monitoring of labor, able and willing to provide informed consent will be invited to participate in this study.

You may not qualify if:

  • Individuals unwilling to use the LCG and unable to provide informed consent will not be eligible to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Mugyenyi GR, Tumuhimbise W, Atukunda EC, Tibaijuka L, Ngonzi J, Kayondo M, Kanyesigye M, Musimenta A, Yarine FT, Byamugisha JK. Effectiveness of the Modified WHO Labour Care Guide to Detect Prolonged and Obstructed Labour Among Women Admitted at Eight Publicly Funded, Midwife-Led Community Health Facilities in Rural Mbarara District, Southwestern Uganda: An Ambispective Cohort Study. Int J Womens Health. 2025 Feb 4;17:271-285. doi: 10.2147/IJWH.S498903. eCollection 2025.

  • Godfrey MR, Wilson T, Esther AC, Leevan T, Joseph N, Musa K, Micheal K, Angella M, Fajardo YT, Josaphat BK. Effectiveness of the modified WHO labour care guide to detect prolonged and obstructed labour among women admitted at publicly funded facilities in rural Mbarara district, Southwestern Uganda: an ambispective cohort study. medRxiv [Preprint]. 2024 Sep 5:2024.09.04.24313073. doi: 10.1101/2024.09.04.24313073.

  • Mugyenyi GR, Byamugisha J, Tumuhimbise W, Atukunda E, Yarine FT. Labour Care Guide implementation as a decision-making tool for monitoring labour among healthcare providers in Uganda: protocol for a mixed-methods study. BMJ Open. 2024 Apr 15;14(4):e079216. doi: 10.1136/bmjopen-2023-079216.

Study Officials

  • Godfrey Mugyenyi, MMed

    Mbarara University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Senior Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 7, 2023

Study Start

August 1, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 7, 2023

Record last verified: 2023-07