Clinical trial NCT05979194: WHO Labor Care Guide for Obstetric Care Providers in Public Health Facilities in Mbarara, Southwestern Uganda
Official title: WHO Labour Care Guide Introduction, Implementation and Use as an Effective Decision-making Tool to Monitor Labor Among Obstetric Care Providers in Publicly Funded Health Facilities in Mbarara District and Mbarara City, Southwestern Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intrapartum Fetal Monitoring
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: I will utilize an ambispective cohort; a combination of a historical cohort of mothers monitored using a partograph and prospective cohort of women monitored using the new Labor Care Guide to evaluate implementation success (effectiveness). As a concerted effort to meaningfully implement a new intervention meant to reduce preventable maternal and perinatal morbidity and mortality, these results will generate grounded, robust scientific data to inform stakeholders and policy makers working towards effectively integrating and scaling up of this new LCG into routine maternity care in similar settings across the country and beyond. This study will also be able to show the effect of this intervention, and optimize its implementation in routine maternity care practice to improve maternal-fetal outcomes in similar settings.

Participants will be adult HCPs actively involved in maternity care and conducting deliveries, health facility managers in Mbarara district and officials from the reproductive health division of the Ugandan Ministry of Health. For the effectiveness-implementation trial, we shall enroll 520 mothers in active labor at the study facilities. Abstracted partograph data from the records of 520 mothers whose labor was monitored using partograph data will be used to compare the proportion of prolonged labor in addition to other effectiveness outcomes.

The main questions we aim

* To 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
* To evaluate the diagnostic accuracy of the new WHO LCG versus the partogram in detecting prolonged labor and reducing rates of obstructed labor among women delivering in Mbarara district Adult HCPs will participate in audio recorded in-dept face to face interviews and adult mothers in labor will be monitored using the New WHO labor care guide to document the proportion of prolonged labor defined as 1) labor crossing the action line on the partograph and 2) labor lasting more than a specified centimeter cervical dilation "time lag" in the alert column of section 5 of the LCG. Secondary outcome measurements will include proportion of obstetric interventions such as caesarean sections, labor augmentation, blood transfusion; quality-of-care; having a fresh still birth; duration of 1st and 2ndstages of labor; 5-minute apgar score, need for resuscitation /blood transfusion, mode of delivery; initiation of breastfeeding; obstetric complications diagnosed and or managed during labor, childbirth or immediate postpartum; ruptured uterus; postpartum hemorrhage; maternal/newborn sepsis; maternal, fetal, and newborn deaths. Other quantitative data that will be collected from maternity records of women that have delivered within one year before and a year after implementation of the labor care guide will include; patient demographics e.g., age, gravidity, parity, gestational age, prenatal, antepartum high-risk morbidities, NCDs, and HCP demographics; age, education, experience, self-efficacy will be collected

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of women with prolonged labor
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of obstetric interventions
timeFrame: 6months
Other outcomes:
Locations:
Study officials:
affiliation: Mbarara University of Science and Technology
name: Godfrey Mugyenyi, MMed
role: PRINCIPAL_INVESTIGATOR
References: