Intrapartum Fetal MonitoringNCT05979194
WHO Labor Care Guide for Obstetric Care Providers in Public Health Facilities in Mbarara, Southwestern Uganda
A study testing Labor Care Guide in people with Intrapartum Fetal Monitoring, run by Mbarara University of Science and Technology.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrapartum Fetal Monitoring
- What is being tested?
- Labor Care Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals unwilling to use the LCG and unable to provide informed consent will not be eligible to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Conditions
- Intrapartum Fetal Monitoring
- Being tested
- Labor Care Guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor Care GuideBehavioural
Identifying information and labor characteristics at admission, supportive care, care of the baby, care of the woman, labor progress, medication, and shared decision-making
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Labor Care Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Proportion of obstetric interventions
proportion of obstetric interventions such as caesarean sections, labour augmentation, blood transfusion; quality-of-care; having a fresh still birth; duration of 1st and 2nd stages of labor; 5-minute apgar score, need for rescuscitation/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
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrapartum Fetal MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Godfrey Mugyenyi, MMed, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979194
- Sponsor's protocol ID
- REC2023
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39925783Godfrey 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.
PubMed 39281732Mugyenyi 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.
PubMed 38626961
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05979194
- Acronym / sponsor ID
- REC2023
- Conditions
- Intrapartum Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Labor care guide | Other | Behavioral: Labor Care GuideIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals unwilling to use the LCG and unable to provide informed consent will not be eligible to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor Care GuideIdentifying information and labor characteristics at admission, supportive care, care of the baby, care of the woman, labor progress, medication, and shared decision-making | Behavioural | Labor care guide |
Primary outcome
Proportion of women with prolonged labor
Time frame: 6 months
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
1 secondary outcome
Proportion of obstetric interventions
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Derived from this study: PubMed 39925783Mugyenyi 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.
- Derived from this study: PubMed 39281732Godfrey 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.
- Derived from this study: PubMed 38626961Mugyenyi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Godfrey Mugyenyi, MMed principal investigator
Mbarara University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Labor Care Guide in people with Intrapartum Fetal Monitoring, run by Mbarara University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senior Lecturer (+256772543238, gmugyenyi@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women with prolonged labor (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05979194, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.