Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-14

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and district level health facilities in Uganda. The program is designed to improve provider competencies, provider performance and health outcomes among women giving birth and newborns.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan

NCT02605369

Neonatal Death Preterm Birth Low Birthweight +1 more

COMPLETED NA

Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach

NCT03290924

Stillbirth Neonatal Death

COMPLETED NA

Saving Babies Lives

NCT04663620

Perinatal Mortality

COMPLETED NA

Improving Newborn Survival In Southern Tanzania

NCT01022788

Newborn Health

COMPLETED NA

Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda

NCT03112018

Pregnancy Complications Preterm Labor PreTerm Birth +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will take place in Uganda at Health Centers (level II, III and IV) and District Hospitals, to reach 'frontline' health providers who attend births. This study will take place in districts meeting study criteria in two regions to demonstrate ability to implement in different geographic settings and potential for scale up. It is a quasi-experimental design with three study arms/groups that receive different levels or intensities and modalities of the program intervention.

Briefly, the same simulator-based training will be provided in all three study arms. After the training, a simulator will be left in the health facility, and providers will be encouraged to practice with it regularly. In two of the study arms, specific health workers will be recruited to support the intervention by encouraging their colleagues to practice with the simulator. In one study arm, the practice will be further reinforced through mobile phone-based support. Following is a more detailed description of each of the three components.

Component 1 (Training): Training is composed of two separate training interventions. First, in each study facility, Ugandan master trainers (district trainers) will conduct a single day, simulator-driven training on PPH prevention and treatment; all providers who attend births will be invited to participate. Eight weeks later, in each facility, the same trainers will conduct a one-day, simulator-driven training for prevention and management of asphyxia in the newborn. After each one-day training, simulators will be left at the facility for practice with a corresponding practice schedule.

Component 2 (Peer-led Practice Sessions): On the day the first training (for PPH), 2 birth attendants at the facility will be selected to serve as clinical mentors (CM). The CMs will be trained to encourage their coworkers to participate in 15-minute practice sessions each week for 8 weeks, in which they will use the simulators to practice the skills learned in the one-day training. After the newborn asphyxia training occurs, these same CMs will be trained to support a similar practice schedule for the following 12 weeks - 8 weeks for newborn asphyxia practice and 4 weeks for combined PPH and asphyxia skills practice.

Component 3 (Mobile phone-based support): CMs will be connected to the district trainer via mobile phone for weekly phone calls during the practice periods to provide reminders and support for practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage Neonatal Asphyxia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Full - Train/oxy&miso/ B&M/Mentor/Phone

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

Group Type EXPERIMENTAL

Helping Mothers Survive - Bleeding After Birth training

Intervention Type OTHER

One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.

Helping Babies Breathe

Intervention Type OTHER

One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag \& mask device.

Mentor

Intervention Type BEHAVIORAL

A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.

Phone

Intervention Type BEHAVIORAL

District trainers telephone clinical mentors and encourage them to lead practice sessions.

oxytocin and misoprostol

Intervention Type DRUG

This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.

Newborn bag and mask

Intervention Type DEVICE

All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care

Partial - Train/oxy & miso/ B&M/Mentor

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.

Group Type EXPERIMENTAL

Helping Mothers Survive - Bleeding After Birth training

Intervention Type OTHER

One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.

Helping Babies Breathe

Intervention Type OTHER

One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag \& mask device.

Mentor

Intervention Type BEHAVIORAL

A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.

oxytocin and misoprostol

Intervention Type DRUG

This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.

Newborn bag and mask

Intervention Type DEVICE

All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care

Comparison - Train/oxy & miso/ B&M

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.

Group Type ACTIVE_COMPARATOR

Helping Mothers Survive - Bleeding After Birth training

Intervention Type OTHER

One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.

Helping Babies Breathe

Intervention Type OTHER

One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag \& mask device.

oxytocin and misoprostol

Intervention Type DRUG

This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.

Newborn bag and mask

Intervention Type DEVICE

All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Helping Mothers Survive - Bleeding After Birth training

One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.

Intervention Type OTHER

Helping Babies Breathe

One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag \& mask device.

Intervention Type OTHER

Mentor

A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.

Intervention Type BEHAVIORAL

Phone

District trainers telephone clinical mentors and encourage them to lead practice sessions.

Intervention Type BEHAVIORAL

oxytocin and misoprostol

This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.

Intervention Type DRUG

Newborn bag and mask

All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HMS BAB HBB CM oxy&miso B&M

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* For Providers: Health providers who attend births in participating health facility and consent to be assessed at the time of enrollment and at several points in time over two years.
* For Clinical mentors: being an experienced skilled birth attendant and likely to remain at the facility during the study period

For Women in Labor and Delivery and Newborns: Women in any stage of labor in participating facility who consent to observation of their delivery and care of their newborn (or consent from the next of kin if the woman is incapacitated and not able to provide consent)

Facility In-charges and Stakeholders: Facility in-charges at sampled health facilities; stakeholders identified by Jhpiego senior managers as being influential in maternal and newborn health policy decisions in Uganda.

Exclusion Criteria

* Providers: has \<1 year of experience, and has plans to be transferred to another facility or leave the facility soon
* Other types of participants: none

Eligible Sex

ALL

Accepts Healthy Volunteers

No