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Behavior ProblemNCT04288947

Changing the Culture of Disrespect and Abuse in Maternity Care in Kumasi, Ghana

A study testing Disrespect and Abuse in Maternity Care in people with Behavior Problem, run by Kwame Nkrumah University of Science and Technology at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 48 years, women onlyHealthy volunteers can take part
Conditions the study is for
Behavior Problem
What is being tested?
Disrespect and Abuse in Maternity Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteGhana
Study dates
14 Jan 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 48 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Midwives providing childbirth care in the various units of Komfo Anokye Teaching Hospital (KATH)
  • Patients receiving maternity care from Midwives Trained or untrained on Respectful Maternity care modules at KATH

Who cannot join

  • Midwives working in other Hospitals apart from KATH
  • Patients receiving care from other units apart from the maternity unit of KATH

Trial locations and contacts

1 site in 1 country.

Ghana1 site
  • Komfo Anokye Teaching Hospital

    Kumasi, 0000

Other trials in Ghana

About this study

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.

Read the detailed 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.

Being tested
Disrespect and Abuse in Maternity Care
Keywords
Disrespect and Abuse, Childbirth, Maternity Care
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disrespect and Abuse in Maternity CareOther

    Changing the culture of disrespect and abuse in maternity care

Study groups in NCT04288947
Study groupRoleWhat they receive
Usual CareOtherTraining of midwives on 4 respectful maternal care modules.
Receives: Other: Disrespect and Abuse in Maternity Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respectful maternal care to women during childbirth as assessed by post natal women during a survey and interview.

    Women are respected during maternal care and childbirth

    Measured: Up to 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start14 Jan 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Training of midwives on 4 respectful maternal care modules.
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04288947
Sponsor's protocol ID
1K43TWO1122--01
Status last verified
Jan 2022
First submitted
18 Feb 2020
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Disrespect and Abuse in Maternity Care in people with Behavior Problem, run by Kwame Nkrumah University of Science and Technology at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respectful maternal care to women during childbirth as assessed by post natal women during a survey and interview. (time frame: Up to 42 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.

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