Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05979194 |
| Other study ID # |
REC2023 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Mbarara University of Science and Technology |
| Contact |
Senior Lecturer |
| Phone |
+256772543238 |
| Email |
gmugyenyi[@]must.ac.ug |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
