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Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation

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ClinicalTrials.gov Identifier: NCT03254628
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Jhpiego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Neonatal Asphyxia Other: Helping Mothers Survive - Bleeding After Birth training Other: Helping Babies Breathe Behavioral: Mentor Behavioral: Phone Drug: oxytocin and misoprostol Device: Newborn bag and mask Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
Actual Study Start Date : November 14, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: 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.
Other: 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.
Other Name: HMS BAB

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.
Other Name: HBB

Behavioral: 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.
Other Name: CM

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

Drug: 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.
Other Name: oxy&miso

Device: 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
Other Name: B&M

Experimental: 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.
Other: 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.
Other Name: HMS BAB

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.
Other Name: HBB

Behavioral: 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.
Other Name: CM

Drug: 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.
Other Name: oxy&miso

Device: 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
Other Name: B&M

Active Comparator: 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,.
Other: 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.
Other Name: HMS BAB

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.
Other Name: HBB

Drug: 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.
Other Name: oxy&miso

Device: 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
Other Name: B&M




Primary Outcome Measures :
  1. Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage [ Time Frame: Baseline, Midline (6 months), Endline (12 months) ]
    The change in the percentage of women who received oxytocin in correct dose immediately after vaginal birth in three study arms, as assessed by direct clinical observation, using a standardized checklist.


Secondary Outcome Measures :
  1. Change in provider performance on simulator-based assessments [ Time Frame: Pre-test (before training)- post-test (immediately after training) - midline (6 months) ]
    The proportion of providers that obtain a passing score on the assessments, based on assessments done by clinical trainers.

  2. Difference in differences: change in care of the mother composite score [ Time Frame: Baseline (before training), Midline (6 months), Endline (12 months) ]
    A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.

  3. Difference in differences: change care of the newborn composite score [ Time Frame: Baseline (before training), Midline (6 months), Endline (12 months) ]
    A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254628


Sponsors and Collaborators
Jhpiego
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Cherrie Evans, DrPH Jhpiego
  Study Documents (Full-Text)

Documents provided by Jhpiego:
Informed Consent Form  [PDF] February 4, 2015


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03254628     History of Changes
Other Study ID Numbers: AID-OAA-A-13-00012
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Death
Wounds and Injuries
Infant, Newborn, Diseases
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents