Postpartum Hemorrhage Clinical Trial
Official title:
Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03434444 -
In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol
|
N/A | |
Terminated |
NCT01980173 -
Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
|
N/A | |
Not yet recruiting |
NCT06033170 -
Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
|
N/A | |
Not yet recruiting |
NCT02319707 -
Management of the Third Stage of Labor
|
Phase 3 | |
Completed |
NCT02163616 -
Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
|
Phase 3 | |
Recruiting |
NCT01600612 -
Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
|
N/A | |
Completed |
NCT02079558 -
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
|
Phase 2 | |
Withdrawn |
NCT01108302 -
Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
|
N/A | |
Completed |
NCT00097123 -
RCT of Misoprostol for Postpartum Hemorrhage in India
|
N/A | |
Completed |
NCT02883673 -
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
|
N/A | |
Completed |
NCT02542813 -
Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers
|
Phase 1 | |
Completed |
NCT04201665 -
EMG for Uterotonic Efficiency Estimation
|
N/A | |
Terminated |
NCT03246919 -
Ideal Time of Oxytocin Infusion During Cesarean Section
|
Phase 4 | |
Not yet recruiting |
NCT05501106 -
Reducing Postpartum Hemorrhage After Vaginal Delivery
|
N/A | |
Completed |
NCT05429580 -
Prophylactic Tranexamic Acid Use After Vaginal Delivery
|
N/A | |
Terminated |
NCT03064152 -
Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
|
N/A | |
Recruiting |
NCT05382403 -
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
|
N/A | |
Completed |
NCT02910310 -
Introduction of UBT for PPH Management in Three Countries
|
N/A | |
Not yet recruiting |
NCT02853552 -
Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding
|
Phase 4 | |
Completed |
NCT02805426 -
Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
|
Phase 4 |