Pregnancy ComplicationsPTBi-KE-UGNCT03112018
Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda
A study testing data strengthening, modified Safe childbirth checklist - enhanced and PRONTO training in people with Pregnancy Complications and Preterm Labor, run by University of California, San Francisco at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Preterm Labor, PreTerm Birth
- What is being tested?
- data strengthening, modified Safe childbirth checklist - enhanced and PRONTO training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102,988 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2016to 31 May 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals: Investigators will include in the analysis the birth outcomes of all women accessing delivery care services at selected hospitals with gestational age of > 24 weeks who are either admitted for labor or for hospitalization for another antenatal complication (preeclampsia, chorioamnionitis) or referred to a tertiary hospital. Women will be presenting at either control or intervention sites and their delivery information will be reviewed. For follow-up, the investigators will select women with infants born at greater than 1000 grams and less than 2500 grams, or between 2501 and 2999 grams with documented gestational age less than 37 weeks.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kenya1 site
Health facilities in Migori County: Rongo, Kehancha, Uriri, Kegonga, Karungu, Tisinye, Isibania, Macalder, Awendo, Ntimaru, Muhuru, Bugumbe, Nyamaraga, Othoro, St. Joseph, St. Camillus, Migori County Referral Hospital
Migori County, Migori County
Uganda1 site
Health facilities in Busoga Region: Bugiri, Buluba, Iganga, Kamuli Government, Kamuli Mission, Jinja Regional Referral Hospital
Busoga Region
About this study
Official title: Strengthening Intrapartum and Immediate Newborn Care to Reduce Morbidity and Mortality of Preterm Infants in Health Facilities in Migori County, Kenya and Busoga Region, Uganda: an Implementation Science RCT
The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.
Read the detailed description
The randomized, controlled cluster trial (RCCT) will test whether the study intervention reduces the combined incidence of fresh stillbirth and neonatal mortality by 30% compared with the control group incidence of FSB+NMR. Given a Type I error of 0.05, power=80%, a one-tailed test, a balanced (1 control :1 intervention) sample, and a baseline PTB NMR of 10%, the RCCT requires 1,133 PTBs in each study group. The sample size has been increased by 35% to account for a 25% design effect and a 10% loss to follow-up/missing information, requires 1,530 PTBs in each study group. Secondary outcomes will be assessed using this sample. The study randomized facilities to either the control or intervention group, matched on various characteristics to improve the similarity of the study groups and minimize design effect. This a priori hypothesis is proposed prior to analyzing the intervention period study primary outcome, using the baseline PTB incidence of FSB+NMR, and an effect size previously observed with PRONTO.
This implementation science study includes a package of interventions. Control sites receive only the limited package of data strengthening and implementation of the modified Safe Childbirth Checklist. The randomly selected intervention facilities receive an enhanced package which also includes provider training/mentoring using PRONTO simulation and teamwork training, ongoing clinical mentoring, and support for Quality Improvement cycles (PDSA cycles) using a Model for Improvement framework. More detail about the contents of the intervention is included below.
Data Strengthening Strategies: initial training focused on routinely collected data plus ongoing refreshers and mentorship throughout study duration
- Strengthen the MOH data collection system (birth registries, admission/discharge registries), as well as introduction of expanded documentation to capture preterm birth details
- Perform facility assessment to determine gaps in infrastructure, supplies as well as skills and competencies of providers and data managers to accurately and consistently report routine facility data
- Support facilities to use standardized definitions of indicators currently collected for antenatal and postnatal care
- Support adherence to national guidelines on documentation in the registers and patient charts through training, provision of registers/charts and motivation
- Introduce expanded routine documentation of preterm births including improving the register to capture data on preterm and still births, and implementation of the modified WHO Safe Childbirth Checklist (see below)
- Support periodic data quality assessment cycles
- Create a synchronized online data dashboard repository system representing key indicators on an ongoing basis with selective access for health care providers and national policy makers
WHO Safe Childbirth Checklist modified to address identification of preterm labor and newborn care for preterm babies: initial training plus ongoing refreshers and mentorship throughout study duration
- Introduce expanded routine documentation of preterm births including the piloting and use of a modified WHO Safe Childbirth Checklist (mSCC)
- Introduce and train on use of the mSCC to detect, manage and treat high risk labor/babies
- Collect routine facility data including register reviews (study staff will visit each selected facility at least once per month)
- Conduct periodic audits of the mSCC to determine uptake and completeness, review for phenotyping information, and/or review for additional service indicators on preterm babies
Measures to strengthen, recommended intrapartum, postnatal and neonatal care in facilities through PRONTO simulation-based provider training and mentorship: training of trainers and initial trainings in Kenya and Uganda plus ongoing mentorship in Kenya and modular refreshers in Uganda, throughout study duration
- Improve intrapartum, postnatal and neonatal management by using a customized PRONTO curriculum that includes highly realistic simulation and focused team training to address gaps in emergency obstetric and neonatal response. The training emphasizes lifesaving response during labor, delivery, postnatal and neonatal periods with specific emphasis on the care of preterm babies.
- Initial 2-days modular PRONTO training will be followed by periodic modular refreshers and supplemental mentoring. In Kenya, this involves 6 one-week mentoring sessions led by trained preterm champions over a 9-12 month period. In Uganda, a modular training model with intermittent refresher trainings and two-day clinical mentoring sessions will be offered over a 9-12 month period. Special emphasis will be put on evidence-based practices and the views gathered from Kenya and Uganda stakeholders.
- Promote close follow-up of preterm babies up to 28-days
Measures to strengthen Quality Improvement (QI) cycles: initial training with ongoing mentorship; QI team meetings each week with quarterly cross-facility collaboration workshops throughout study duration
- Develop tools for, introduce and institutionalize QI cycles and regular project monitoring and evaluation
- Reinforcement of accurate and timely documentation in charts and registers in the facilities
- Reinforcement of use of the mSCC, including its use as a data source to track progress of change efforts
- Link system gaps or latent errors uncovered during simulation training and suggested solutions with QI efforts
- Develop and recommend some tools to improve data collection such as for triage, discharge and referral
- Being tested
- data strengthening, modified Safe childbirth checklist - control, modified Safe childbirth checklist - enhanced, PRONTO training, QI cycles
- Keywords
- premature birth, neonatal mortality, premature infant
- Medical subject headings
- Pregnancy Complications, Obstetric Labor, Premature, Premature Birth, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data strengtheningBehavioural
Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments
modified Safe childbirth checklist - controlBehavioural
modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, limited feedback and mentoring on its use
modified Safe childbirth checklist - enhancedBehavioural
modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, ongoing intensive feedback and mentoring on its use
PRONTO trainingBehavioural
Health provider training (PRONTO): initial 2-days modular training followed by a 6-week mentoring sessions (Kenya) or periodic modular refreshers and supplemental mentoring (Uganda), each over a 9-12 month period
QI cyclesBehavioural
Quality Improvement Cycles (QI): facility teams performing PDSA cycles with mentoring support and twice annual Learning Collaborative sessions, plus opportunities to apply for small amounts of funds to support change efforts
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | * Data strengthening
* modified Safe Childbirth Checklist (mSCC) implementation Receives: Behavioral: data strengthening; Behavioral: modified Safe childbirth checklist - control |
| Enhanced care (intervention) | Experimental | * Data strengthening
* modified Safe Childbirth Checklist (mSCC) implementation
* Health provider training (PRONTO)
* Quality Improvement (QI) Cycles Receives: Behavioral: data strengthening; Behavioral: modified Safe childbirth checklist - enhanced; Behavioral: PRONTO training; Behavioral: QI cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause neonatal mortality among preterms/low birth weight newborns
To determine the effect of the full package (data strengthening, mSCC, provider training and mentoring using the PRONTO method, QI cycles) on 28-day all-cause mortality rate among low birth weight neonates greater than 1000 grams and less than 2500 grams, and neonates between 2500 and 2999 grams with documented gestational age less than 37 weeks
Measured: 28-days after facility-based delivery
Secondary outcomes (6)
Data quality of key indicators in facility-based registers
Key indicators include gestational age, facility discharge status, preterm birth incidence
Measured: through study completion, an average of 18 months
Pre-hospital discharge mortality among preterm infants and babies born alive between 500 and 999 grams at birth
Measured: at hospital discharge, an average of 1-7 days
28-day mortality among babies born alive between 500 and 999 grams at birth
Measured: 28-days after facility-based delivery
Average number of evidence-based practices demonstrated in simulated case videos and live birth observations
Uptake and appropriate utilization of evidence-based interventions/ Ministry of Health management guidelines measured in PRONTO simulation videos, observed live births and/or mSCC
Measured: Baseline and through study completion, an average of 18 months
Prevalence of preterm birth phenotypes in the study sites as measured by chart review and the mSCC
Measured: Every year over four years
Facility readiness to handle delivery and newborn complications as measured by a facility assessment tool
Measured: Every six months over two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Oct 2016
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Kenya Medical Research Institute
- Responsible party
- Principal investigator, Dilys Walker, University of California, San Francisco
- Investigators
- Dilys Walker, MD, Principal investigator, University of California, San FranciscoPeter Waiswa, MD, MPH, PhD, Principal investigator, Makerere University School of PublicPhelgona Otieno, MBChB, MPH, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112018
- Sponsor's protocol ID
- A123218-K/U
- Acronym
- PTBi-KE-UG
- Status last verified
- Jun 2019
- First submitted
- 19 Dec 2016
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mandu R, Miller L, Namazzi G, Twum-Danso N, Achola KJA, Cooney I, Butrick E, Santos N, Masavah L, Nyakech A, Kirumbi L, Waiswa P, Walker D. Quality improvement collaboratives as part of a quality improvement intervention package for preterm births at sub-national level in East Africa: a multi-method analysis. BMJ Open Qual. 2023 Dec 21;12(4):e002443. doi: 10.1136/bmjoq-2023-002443.
PubMed 38135302Martin-Herz SP, Otieno P, Laanoi GM, Moshi V, Olieng'o Okoth G, Santos N, Walker D. Growth and neurodevelopmental outcomes of preterm and low birth weight infants in rural Kenya: a cross-sectional study. BMJ Open. 2023 Aug 31;13(8):e064678. doi: 10.1136/bmjopen-2022-064678.
PubMed 37652593Ghosh R, Otieno P, Butrick E, Santos N, Waiswa P, Walker D; Preterm Birth Initiative Kenya and Uganda Implementation Research Collaborative. Effect of a quality improvement intervention for management of preterm births on outcomes of all births in Kenya and Uganda: A secondary analysis from a facility-based cluster randomized trial. J Glob Health. 2022 Dec 29;12:04073. doi: 10.7189/jogh.12.04073.
PubMed 36580073Ghosh R, Santos N, Butrick E, Wanyoro A, Waiswa P, Kim E, Walker D. Stillbirth, neonatal and maternal mortality among caesarean births in Kenya and Uganda: a register-based prospective cohort study. BMJ Open. 2022 Apr 6;12(4):e055904. doi: 10.1136/bmjopen-2021-055904.
PubMed 35387820Whaley B, Butrick E, Sales JM, Wanyoro A, Waiswa P, Walker D, Cranmer JN. Using clinical cascades to measure health facilities' obstetric emergency readiness: testing the cascade model using cross-sectional facility data in East Africa. BMJ Open. 2022 Apr 4;12(4):e057954. doi: 10.1136/bmjopen-2021-057954.
PubMed 35379635Achola KA, Kajjo D, Santos N, Butrick E, Otare C, Mubiri P, Namazzi G, Merai R, Otieno P, Waiswa P, Walker D. Implementing the WHO Safe Childbirth Checklist modified for preterm birth: lessons learned and experiences from Kenya and Uganda. BMC Health Serv Res. 2022 Mar 3;22(1):294. doi: 10.1186/s12913-022-07650-x.
PubMed 35241076Namazzi G, Achola KA, Jenny A, Santos N, Butrick E, Otieno P, Waiswa P, Walker D; Preterm Birth Initiative Kenya & Uganda Implementation Research Collaborative. Implementing an intrapartum package of interventions to improve quality of care to reduce the burden of preterm birth in Kenya and Uganda. Implement Sci Commun. 2021 Jan 28;2(1):10. doi: 10.1186/s43058-021-00109-w.
PubMed 33509293Walker D, Otieno P, Butrick E, Namazzi G, Achola K, Merai R, Otare C, Mubiri P, Ghosh R, Santos N, Miller L, Sloan NL, Waiswa P; Preterm Birth Initiative Kenya and Uganda Implementation Research Collaborative. Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial. Lancet Glob Health. 2020 Aug;8(8):e1061-e1070. doi: 10.1016/S2214-109X(20)30232-1.
PubMed 32710862Otieno P, Waiswa P, Butrick E, Namazzi G, Achola K, Santos N, Keating R, Lester F, Walker D. Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial. Trials. 2018 Jun 5;19(1):313. doi: 10.1186/s13063-018-2696-2.
PubMed 29871696
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Intrapartum and Immediate Newborn Care to Reduce Morbidity and Mortality of Preterm Infants in Health Facilities in Migori County, Kenya and Busoga Region, Uganda: an Implementation Science RCT
- ClinicalTrials.gov ID
- NCT03112018
- Acronym / sponsor ID
- PTBi-KE-UG / A123218-K/U
- Keywords
- premature birth, neonatal mortality, premature infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102,988 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Makerere University, Kenya Medical Research Institute
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 13 Apr 2017 (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 purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.
Detailed description
The randomized, controlled cluster trial (RCCT) will test whether the study intervention reduces the combined incidence of fresh stillbirth and neonatal mortality by 30% compared with the control group incidence of FSB+NMR. Given a Type I error of 0.05, power=80%, a one-tailed test, a balanced (1 control :1 intervention) sample, and a baseline PTB NMR of 10%, the RCCT requires 1,133 PTBs in each study group. The sample size has been increased by 35% to account for a 25% design effect and a 10% loss to follow-up/missing information, requires 1,530 PTBs in each study group. Secondary outcomes will be assessed using this sample. The study randomized facilities to either the control or intervention group, matched on various characteristics to improve the similarity of the study groups and minimize design effect. This a priori hypothesis is proposed prior to analyzing the intervention period study primary outcome, using the baseline PTB incidence of FSB+NMR, and an effect size previously observed with PRONTO.
This implementation science study includes a package of interventions. Control sites receive only the limited package of data strengthening and implementation of the modified Safe Childbirth Checklist. The randomly selected intervention facilities receive an enhanced package which also includes provider training/mentoring using PRONTO simulation and teamwork training, ongoing clinical mentoring, and support for Quality Improvement cycles (PDSA cycles) using a Model for Improvement framework. More detail about the contents of the intervention is included below.
Data Strengthening Strategies: initial training focused on routinely collected data plus ongoing refreshers and mentorship throughout study duration
- Strengthen the MOH data collection system (birth registries, admission/discharge registries), as well as introduction of expanded documentation to capture preterm birth details
- Perform facility assessment to determine gaps in infrastructure, supplies as well as skills and competencies of providers and data managers to accurately and consistently report routine facility data
- Support facilities to use standardized definitions of indicators currently collected for antenatal and postnatal care
- Support adherence to national guidelines on documentation in the registers and patient charts through training, provision of registers/charts and motivation
- Introduce expanded routine documentation of preterm births including improving the register to capture data on preterm and still births, and implementation of the modified WHO Safe Childbirth Checklist (see below)
- Support periodic data quality assessment cycles
- Create a synchronized online data dashboard repository system representing key indicators on an ongoing basis with selective access for health care providers and national policy makers
WHO Safe Childbirth Checklist modified to address identification of preterm labor and newborn care for preterm babies: initial training plus ongoing refreshers and mentorship throughout study duration
- Introduce expanded routine documentation of preterm births including the piloting and use of a modified WHO Safe Childbirth Checklist (mSCC)
- Introduce and train on use of the mSCC to detect, manage and treat high risk labor/babies
- Collect routine facility data including register reviews (study staff will visit each selected facility at least once per month)
- Conduct periodic audits of the mSCC to determine uptake and completeness, review for phenotyping information, and/or review for additional service indicators on preterm babies
Measures to strengthen, recommended intrapartum, postnatal and neonatal care in facilities through PRONTO simulation-based provider training and mentorship: training of trainers and initial trainings in Kenya and Uganda plus ongoing mentorship in Kenya and modular refreshers in Uganda, throughout study duration
- Improve intrapartum, postnatal and neonatal management by using a customized PRONTO curriculum that includes highly realistic simulation and focused team training to address gaps in emergency obstetric and neonatal response. The training emphasizes lifesaving response during labor, delivery, postnatal and neonatal periods with specific emphasis on the care of preterm babies.
- Initial 2-days modular PRONTO training will be followed by periodic modular refreshers and supplemental mentoring. In Kenya, this involves 6 one-week mentoring sessions led by trained preterm champions over a 9-12 month period. In Uganda, a modular training model with intermittent refresher trainings and two-day clinical mentoring sessions will be offered over a 9-12 month period. Special emphasis will be put on evidence-based practices and the views gathered from Kenya and Uganda stakeholders.
- Promote close follow-up of preterm babies up to 28-days
Measures to strengthen Quality Improvement (QI) cycles: initial training with ongoing mentorship; QI team meetings each week with quarterly cross-facility collaboration workshops throughout study duration
- Develop tools for, introduce and institutionalize QI cycles and regular project monitoring and evaluation
- Reinforcement of accurate and timely documentation in charts and registers in the facilities
- Reinforcement of use of the mSCC, including its use as a data source to track progress of change efforts
- Link system gaps or latent errors uncovered during simulation training and suggested solutions with QI efforts
- Develop and recommend some tools to improve data collection such as for triage, discharge and referral
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: data strengthening, Behavioral: modified Safe childbirth checklist - control* Data strengthening * modified Safe Childbirth Checklist (mSCC) implementation |
| Enhanced care (intervention) | Experimental | Behavioral: data strengthening, Behavioral: modified Safe childbirth checklist - enhanced, Behavioral: PRONTO training, Behavioral: QI cycles* Data strengthening * modified Safe Childbirth Checklist (mSCC) implementation * Health provider training (PRONTO) * Quality Improvement (QI) Cycles |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals: Investigators will include in the analysis the birth outcomes of all women accessing delivery care services at selected hospitals with gestational age of > 24 weeks who are either admitted for labor or for hospitalization for another antenatal complication (preeclampsia, chorioamnionitis) or referred to a tertiary hospital. Women will be presenting at either control or intervention sites and their delivery information will be reviewed. For follow-up, the investigators will select women with infants born at greater than 1000 grams and less than 2500 grams, or between 2501 and 2999 grams with documented gestational age less than 37 weeks.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| data strengtheningData strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments | Behavioural | Enhanced care (intervention), Standard care |
| modified Safe childbirth checklist - controlmodified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, limited feedback and mentoring on its use | Behavioural | Standard care |
| modified Safe childbirth checklist - enhancedmodified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, ongoing intensive feedback and mentoring on its use | Behavioural | Enhanced care (intervention) |
| PRONTO trainingHealth provider training (PRONTO): initial 2-days modular training followed by a 6-week mentoring sessions (Kenya) or periodic modular refreshers and supplemental mentoring (Uganda), each over a 9-12 month period | Behavioural | Enhanced care (intervention) |
| QI cyclesQuality Improvement Cycles (QI): facility teams performing PDSA cycles with mentoring support and twice annual Learning Collaborative sessions, plus opportunities to apply for small amounts of funds to support change efforts | Behavioural | Enhanced care (intervention) |
Primary outcome
all-cause neonatal mortality among preterms/low birth weight newborns
Time frame: 28-days after facility-based delivery
To determine the effect of the full package (data strengthening, mSCC, provider training and mentoring using the PRONTO method, QI cycles) on 28-day all-cause mortality rate among low birth weight neonates greater than 1000 grams and less than 2500 grams, and neonates between 2500 and 2999 grams with documented gestational age less than 37 weeks
6 secondary outcomes
Data quality of key indicators in facility-based registers
Time frame: through study completion, an average of 18 months
Pre-hospital discharge mortality among preterm infants and babies born alive between 500 and 999 grams at birth
Time frame: at hospital discharge, an average of 1-7 days
28-day mortality among babies born alive between 500 and 999 grams at birth
Time frame: 28-days after facility-based delivery
Average number of evidence-based practices demonstrated in simulated case videos and live birth observations
Time frame: Baseline and through study completion, an average of 18 months
Prevalence of preterm birth phenotypes in the study sites as measured by chart review and the mSCC
Time frame: Every year over four years
Facility readiness to handle delivery and newborn complications as measured by a facility assessment tool
Time frame: Every six months over two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 38135302Mandu R, Miller L, Namazzi G, Twum-Danso N, Achola KJA, Cooney I, Butrick E, Santos N, Masavah L, Nyakech A, Kirumbi L, Waiswa P, Walker D. Quality improvement collaboratives as part of a quality improvement intervention package for preterm births at sub-national level in East Africa: a multi-method analysis. BMJ Open Qual. 2023 Dec 21;12(4):e002443. doi: 10.1136/bmjoq-2023-002443.
- Derived from this study: PubMed 37652593Martin-Herz SP, Otieno P, Laanoi GM, Moshi V, Olieng'o Okoth G, Santos N, Walker D. Growth and neurodevelopmental outcomes of preterm and low birth weight infants in rural Kenya: a cross-sectional study. BMJ Open. 2023 Aug 31;13(8):e064678. doi: 10.1136/bmjopen-2022-064678.
- Derived from this study: PubMed 36580073Ghosh R, Otieno P, Butrick E, Santos N, Waiswa P, Walker D; Preterm Birth Initiative Kenya and Uganda Implementation Research Collaborative. Effect of a quality improvement intervention for management of preterm births on outcomes of all births in Kenya and Uganda: A secondary analysis from a facility-based cluster randomized trial. J Glob Health. 2022 Dec 29;12:04073. doi: 10.7189/jogh.12.04073.
- Derived from this study: PubMed 35387820Ghosh R, Santos N, Butrick E, Wanyoro A, Waiswa P, Kim E, Walker D. Stillbirth, neonatal and maternal mortality among caesarean births in Kenya and Uganda: a register-based prospective cohort study. BMJ Open. 2022 Apr 6;12(4):e055904. doi: 10.1136/bmjopen-2021-055904.
- Derived from this study: PubMed 35379635Whaley B, Butrick E, Sales JM, Wanyoro A, Waiswa P, Walker D, Cranmer JN. Using clinical cascades to measure health facilities' obstetric emergency readiness: testing the cascade model using cross-sectional facility data in East Africa. BMJ Open. 2022 Apr 4;12(4):e057954. doi: 10.1136/bmjopen-2021-057954.
- Derived from this study: PubMed 35241076Achola KA, Kajjo D, Santos N, Butrick E, Otare C, Mubiri P, Namazzi G, Merai R, Otieno P, Waiswa P, Walker D. Implementing the WHO Safe Childbirth Checklist modified for preterm birth: lessons learned and experiences from Kenya and Uganda. BMC Health Serv Res. 2022 Mar 3;22(1):294. doi: 10.1186/s12913-022-07650-x.
- Derived from this study: PubMed 33509293Namazzi G, Achola KA, Jenny A, Santos N, Butrick E, Otieno P, Waiswa P, Walker D; Preterm Birth Initiative Kenya & Uganda Implementation Research Collaborative. Implementing an intrapartum package of interventions to improve quality of care to reduce the burden of preterm birth in Kenya and Uganda. Implement Sci Commun. 2021 Jan 28;2(1):10. doi: 10.1186/s43058-021-00109-w.
- Derived from this study: PubMed 32710862Walker D, Otieno P, Butrick E, Namazzi G, Achola K, Merai R, Otare C, Mubiri P, Ghosh R, Santos N, Miller L, Sloan NL, Waiswa P; Preterm Birth Initiative Kenya and Uganda Implementation Research Collaborative. Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial. Lancet Glob Health. 2020 Aug;8(8):e1061-e1070. doi: 10.1016/S2214-109X(20)30232-1.
- Derived from this study: PubMed 29871696Otieno P, Waiswa P, Butrick E, Namazzi G, Achola K, Santos N, Keating R, Lester F, Walker D. Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial. Trials. 2018 Jun 5;19(1):313. doi: 10.1186/s13063-018-2696-2.
- PRONTO websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Dilys Walker, MD principal investigator
University of California, San Francisco
Peter Waiswa, MD, MPH, PhD principal investigator
Makerere University School of Public
Phelgona Otieno, MBChB, MPH principal investigator
Kenya Medical Research Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing data strengthening, modified Safe childbirth checklist - enhanced and PRONTO training in people with Pregnancy Complications and Preterm Labor, run by University of California, San Francisco at 2 sites in 2 countries.
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 0 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: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause neonatal mortality among preterms/low birth weight newborns (time frame: 28-days after facility-based delivery). 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 NCT03112018, which also lists 9 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 18 Jun 2019.