NCT04288947

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 17, 2023

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

February 18, 2020

Last Update Submit

March 16, 2023

Conditions

Keywords

Disrespect and AbuseChildbirthMaternity Care

Outcome Measures

Primary Outcomes (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

    Up to 42 months

Study Arms (1)

Usual Care

OTHER

Training of midwives on 4 respectful maternal care modules.

Other: Disrespect and Abuse in Maternity Care

Interventions

Changing the culture of disrespect and abuse in maternity care

Usual Care

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, 0000, Ghana

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Prenatal Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsMaternal Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Peter Donkor

    Kwame Nkrumah University of Science and Technology

    STUDY DIRECTOR
  • Jody Lori, PhD

    University of Michigan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Training of midwives on 4 respectful maternal care modules.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 28, 2020

Study Start

January 14, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 17, 2023

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations