Parturition Clinical Trial
Official title:
Field Validation of Training Materials and Methods to Build Capacity of Skilled Birth Attendants at Labor and Birth in the Helping Mothers Survive Module 'Essential Care for Labor & Birth' to Improve Quality of Care in Zanzibar
The goal of this study is to ensure that the training materials and methods for the training
module Helping Mothers Survive Essential Care for Labor & Birth (ECL&B) are usable and
acceptable by trainers and healthcare providers in Zanzibar. Findings from this study will be
used to improve the modules and validate the trainee assessments. This study also compares
provider learning outcomes in the training module delivered with and without video
demonstration.
Focusing on the first two phases of the Kirkpatrick model, the field validation will answer
the following research questions:
1. How acceptable and appropriate for adequate teaching and learning is the training
module?
2. What is the gain in knowledge, clinical decision-making, communication, and psychomotor
skills of the trainees from pre to post-training assessment? (immediate learner
outcomes)
3. Is there a difference in immediate learner outcomes in training where video clips are
used during training to supplement live trainer demonstration compared to training where
video is not used as a supplement?
The goal of this study is to ensure that the training materials and methods for the training
module Helping Mothers Survive Essential Care for Labor & Birth (ECL&B) are usable and
acceptable by trainers and healthcare providers in Zanzibar prior to implementing the
training. Findings from this study will be used to improve the modules and validate the
trainee assessments. This study also compares provider learning outcomes in the training
module delivered with and without video demonstration.
Focusing on the first two phases of the Kirkpatrick model, the field validation is designed
to answer the following research questions:
1. How acceptable and appropriate for adequate teaching and learning is the training
module?
2. What is the gain in knowledge, clinical decision-making, communication, and psychomotor
skills of the trainees from pre to post-training assessment? (immediate learner
outcomes)
3. Is there a difference in immediate learner outcomes in training where video clips are
used during training to supplement live trainer demonstration compared to training where
video is not used as a supplement?
Background: To improve the quality of antenatal, intrapartum, and postpartum care, and thus
reduce maternal and newborn morbidity and mortality, Jhpiego, in conjunction with global
partners, has developed Helping Mothers Survive (HMS), a suite of training modules for
frontline providers to use in low- and middle-income countries. HMS is a series of one or
two-day, hands-on training modules followed by low-dose, high-frequency (LDHF) practice and
other quality improvement activities. These modules are delivered at the worksite to provide
ongoing support for clinical performance after training.
The importance of high-quality care during routine labor and birth to ensure the survival of
women and their newborns cannot be overstated. The third module in the HMS series addresses
the training needs for care during normal labor and birth (ECL&B). The ECL&B module is based
on latest WHO guidance.
HMS training modules are developed to specifically address this gap with a plan for "low
dose, high frequency" training to offer "boosters" to ensure competency in individual
clinical areas and to consolidate skills through practice after training. Local health
facility-based providers are responsible for leading short, frequent refresher practice
sessions with their peers. Trained providers also conduct quality improvement activities and
offer initial simulation-based training for new employees. This emphasis on local capacity
building within health facilities makes validation of this training method and accompanying
materials important. In addition, because this training will ultimately be disseminated at a
larger scale, it is vital that the materials and methods be tested in resource-limited
settings at this early stage.
As training in the Helping Mothers Survive modules becomes more widely available through a
variety of partner organizations, a concern is that local trainers' skills demonstrations
will have high variability in terms of the quality of the training demonstrations resulting
in variation in acquisition of learner competencies. This study will investigate whether HMS
ECL&B training using in-person trainer supplemented with video demonstrations for several key
skills results in better learner competencies immediately post-training compared to the same
training with live trainers only.
This mixed-methods, quasi-experimental two-arm study is formative and a pre- and
post-training assessment of the training intervention. In the experimental arm, participants
(clinicians also called skilled birth attendants) will receive training supplemented with
video. In the comparison arm, participants will receive training with no video. This study is
similar to the field validation studies for the Bleeding After Birth (BAB) module (Johns
Hopkins Bloomberg School of Public Health IRB #0004062) and the BAB+ and
Pre-eclampsia/Eclampsia (PE&E) modules (IRB #0007038), completed in 2012 and 2016,
respectively, with the addition of an evaluation of video use as a supplement to a live
trainer using the HMS training materials.
To assess acceptability of the intervention, focus groups with trainers and providers will be
conducted. To assess clinicians' learning in the HMS modules and skill acquisition, there
will be knowledge tests, a confidence assessment and three objective structured clinical
examination scenarios. Participants' characteristics and past clinical experience will be
measured through the self-administered survey.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05708482 -
Sling and Swing Positions to Pregnant Women
|
N/A | |
Terminated |
NCT01320995 -
Perineal Echography in the Delivery Room for the Detection of Anal Lesions
|
N/A | |
Recruiting |
NCT04603859 -
When to INDuce for OverWeight? (WINDOW)
|
N/A | |
Completed |
NCT01131260 -
Fetal ST Segment and T Wave Analysis in Labor
|
N/A | |
Completed |
NCT01164657 -
A Swedish Trial of Birth on a Birthing Seat
|
N/A | |
Completed |
NCT03441243 -
Evaluation of the Psychological Consequences of Complicated Childbirth
|
||
Completed |
NCT00323401 -
The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood
|
N/A | |
Completed |
NCT03490682 -
Gastric Emptying During the Labour
|
N/A | |
Completed |
NCT02870712 -
Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth
|
N/A | |
Not yet recruiting |
NCT02361853 -
The Role of Immature Myeloid Cells, Monocytes, Dentritic Cells and Neutrophils in Human Pregnancies as Markers for Mature Pregnancy and Spontaneous Labor
|
N/A | |
Not yet recruiting |
NCT02363036 -
The Shift From Monocytes to Neutrophils in Blood Samples of Women in Labor
|
N/A | |
Not yet recruiting |
NCT02493192 -
Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour
|
Phase 4 | |
Completed |
NCT04432675 -
Effects of Crystal Solution and Colloid Solution on Mother and Fetus
|
Phase 4 | |
Recruiting |
NCT01051726 -
Effects of Aromatherapy on Childbirth
|
Phase 2 | |
Completed |
NCT05820958 -
Intensified Tactile Contact With a Newborn Andt Emotional Transformation of the Mother
|
N/A | |
Completed |
NCT06069596 -
Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
|
Phase 4 | |
Recruiting |
NCT06380400 -
The Effect of Foot Bath on Birth Pain and Birth Comfort
|
N/A | |
Enrolling by invitation |
NCT02408588 -
Evaluation of Compensatory Reserve in Obstetrical Patients
|
||
Not yet recruiting |
NCT04657107 -
The Efficacy and Safety of S-ketamine in Elective Cesarean Section
|
N/A | |
Completed |
NCT02823418 -
Neuraxial Labor Analgesia and the Incidence of Postpartum Depression
|