PreTerm Birth Clinical Trial
— PTBi-KE-UGOfficial 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
Verified date | June 2019 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102988 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Kenya | 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 | |
Uganda | Health facilities in Busoga Region: Bugiri, Buluba, Iganga, Kamuli Government, Kamuli Mission, Jinja Regional Referral Hospital | Busoga Region |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Kenya Medical Research Institute, Makerere University |
Kenya, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 28-days after facility-based delivery | |
Secondary | Data quality of key indicators in facility-based registers | Key indicators include gestational age, facility discharge status, preterm birth incidence | through study completion, an average of 18 months | |
Secondary | Pre-hospital discharge mortality among preterm infants and babies born alive between 500 and 999 grams at birth | at hospital discharge, an average of 1-7 days | ||
Secondary | 28-day mortality among babies born alive between 500 and 999 grams at birth | 28-days after facility-based delivery | ||
Secondary | 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 | Baseline and through study completion, an average of 18 months | |
Secondary | Prevalence of preterm birth phenotypes in the study sites as measured by chart review and the mSCC | Every year over four years | ||
Secondary | Facility readiness to handle delivery and newborn complications as measured by a facility assessment tool | Every six months over two years |
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