Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04288947 |
| Other study ID # |
1K43TWO1122--01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2019 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Kwame Nkrumah University of Science and Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Using a public health facility Komfo Anokye Teaching Hospital in Ghana the overall goal of
the research is to examine: 1) the feasibility of implementing respectful care modules
(RMC-M) in Kumasi, Ghana; 2) whether exposure to RMC-M increases participants perception of
respectful maternity care in a public hospital setting in Ghana; and 3) the efficacy of RMC-M
in changing midwives' attitudes, behaviors and clinical practice patterns. To achieve Aim 1,
qualitative and quantitative study designs will be used to assess for reliability of
implementation, usefulness, and patient responsiveness. Based on data collected, feasibility
will be examined and the RMC-M will be further modified as needed prior to beginning Aim 2.
To achieve Aim 2, a two group study design will be used, with one group of midwives receiving
training on the RMC- M and the other not receiving any training. Participants receiving care
from these two groups of midwives will be followed through intrapartum and surveyed
postpartum to examine their perceptions of the care they received. To achieve Aim 3, a
pre-post study design will examine whether expose to a RMC-M changes midwives' attitudes,
behaviors, and clinical care of participants during labor and delivery.
Description:
There is a growing recognition of disrespectful and abusive care of pregnant women during
labor and delivery. Fear of maltreatment during labor and delivery has been identified as one
barrier that prevents pregnant women from delivering in a facility.[1-3]. Pregnant Women
report lack of sympathy and empathy, neglect, rudeness and verbally abusive behaviour,
physically abusive behavior, lack of temperamental control, inadequate attention, and lack of
privacy in skilled health care centres.[3,4] These form barriers to effective use of
facilities[3,5,6] for childbirth as pregnant women recount that they receive better health
care at home than in health facilities which is the only setting where skilled birth is
provided in Ghana. Additionally, facility-based childbirth is known to avert mortality
associated with deliveries which are often not detectable during prenatal care.[5,6]
Currently, 1500 women die daily in sub-Saharan Africa from complications related to
childbirth. [7,8] In the developing world, the life-time hazard of a woman dying from risks
associated with pregnancy and child-birth is more than 300 times greater than for a woman
living in a developed country; no other mortality rate has this disparity.[9] In Ghana, the
current maternal mortality ratio is 380 per 100,000 live births and only 42% of women receive
skilled childbirth care.
Four Respectful Maternity Care Modules (RMC-M) were developed from data collected during the
candidate's dissertation research on disrespect and abuse in intrapartum care at four public
hospitals in Ghana and from literature on the state of the science on disrespect and abuse.
The content for four evidence-based modules includes topics on: 1) respect and dignity in
childbirth; 2) communication; 3) focused antenatal care; and 4) use of alternative birthing
positions for delivery. The modules use interactive teaching and learning methods such as
role play, discussion, brain-storming, demonstration, and case study to discover acceptable
practices, skills, and attitudes for respectful care provision. The intervention has the
potential to improve pregnant women's experience of facility-based childbirth, therefore
increasing satisfaction and decreasing home delivery. The RMC-M is proposed for midwives
working in prenatal, intrapartum and postnatal facility-based childbirth units. Despite the
proposed strengths of the RMC-M as a tool to improve perceptions of maternity care with
facility-based childbirth, the fidelity and uptake of the intervention have not been tested.
The purpose of this study is to test an intervention to promote respectful facility-based
maternity care that can be delivered by midwives in Ghana in a public hospital setting
through the following specific aims:
Specific Aim #1: Examine the feasibility of implementing respectful maternity care modules in
Kumasi, Ghana.
The investigators will assign 10 professional midwives to receive training on Respectful
Maternity Care Modules (RMC-M). During the training, we will use qualitative and quantitative
analytic techniques to examine the feasibility of implementing the RMC-M in Ghana focused on:
1) reliability of implementation, 2) usefulness, and 3) patient responsiveness. Based on data
collected, feasibility will be examined and the RMC-M will be further modified as needed
prior to beginning Aim 2.
Specific Aim #2: Examine whether exposure to RMC-M increases Ghanaian women's perception of
respectful maternity care in a public hospital setting in Ghana.
In order to meet aim #2, a two-group comparison design will be used with one group of
pregnant women (n=62) receiving care from midwives trained in the RMC-M and the other group
of pregnant women (n=62) receiving care from midwives who received a four module program in
basic emergency obstetric and newborn care (BEmONC). Ten additional midwives will be trained
in BEmONC prior to data collection. Data will be collected from postpartum women on their
perception of intrapartum care.
It is hypothesized that postpartum women who receive care from midwives trained in the RMC-M
interventions will score higher on a RMC scale than those women in the comparison group.
Specific Aim #3: Examine the efficacy of RMC-M in changing midwives' attitudes, behaviors,
and clinical practice patterns.
Using a pre-post study design to examine whether exposure to the RMC-M changes midwives'
attitudes, behaviors, and clinical practice in the care of women during labor and delivery.
The investigators will survey midwives prior to implementing training on the RMC-M and
following completion of aim #2.
It is hypothesized that midwives trained in the RMC-M interventions will have a significant
change in attitudes, behaviors, and clinical practice than those midwives in the comparison
group.
