Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202008781392078 Date of Approval: 03/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Promoting Respectful Maternity Care for Adolescents: A Quasi-experimental Study
Official scientific title Promoting Respectful Maternity Care for Adolescents: A Quasi-experimental Study
Brief summary describing the background and objectives of the trial Intra-partum mistreatment by healthcare providers remains a global public heath and human rights challenge. Adolescent women, who are typically younger, poorer and less educated have been suggested to be disproportionately exposed to intra-partum mistreatment. In Ghana, maternal mortality remains a leading cause of death among adolescent females, despite increasing use of skilled birth attendance in health facilities. In response to the WHO-HRP alliance’s recommendations to address mistreatment with Respectful Maternity Care (RMC), this study aims to generate evidence on promoting respectful treatment of adolescents using an intervention that trains health providers on the concept of mistreatment, their professional roles in RMC and the rights of adolescents to RMC
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/08/2020
Actual trial start date
Anticipated date of last follow up 31/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 392
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Facility Based Respectful Maternity Care Training One two-day event per facility 2-days The proposed intervention is a training module facilitated with the aid of a resource package adapted from the White Ribbon Alliance/ USAID “Respectful Maternity Care for Healthcare Workers: Tackling Disrespect & Abuse During Facility-Based Childbirth” project. Additionally, the structure and content of the module is influenced by evidence from previous studies and systematic reviews on mistreatment and RMC. This course will be presented in the format of presentations, case studies, role plays, discussions and evaluations. The content will cover the adolescent and their reproductive health rights, the GHS code of professional ethics, Nurses & Midwives Code of Conduct, definitions and typologies of mistreatment and RMC as well as their outcomes to the woman, neonate, professional and health system. The content will also cover the professionals’ role in the delivery of RMC. 50
Control Group No intervention standard treatment of care N/A N/A There will be no intervention rolled out for control facilities 50 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents will be deemed eligible for participation if they satisfy the following criteria i. Between the ages of 10 and 19 years ii. Present at any of the selected health facilities for delivery iii. Consent to participate in the study Health professionals will be deemed eligible i. Midwives who work at the selected health facilities ii. Consent to participate in the study Do not consent to participate in study Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 10 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2020 Ghana Health Service Ethics Approval Committee
Ethics Committee Address
Street address City Postal code Country
Barnes Road, Adabraka Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in mistreatment prevalence Endline which is from Day 1 post intervention
Secondary Outcome Increase in RMC practices Endline which is from Day 1 post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ghana School of Public Health Noguchi Link, Legon Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
WHO HRP Alliance 20 Avenue Appia, Geneva Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor WHO HRP Alliance 20 Avenue Appia Geneva Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Augustine Ankomah 204 Yiyiwa drive Accra Ghana
Kwasi Torpey Noguchi Link, University of Ghana Campus, Legon Accra Ghana
Ernest Tei Maya Noguchi Link, University of Ghana Campus, Legon Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Helen Habib helenhabib1@yahoo.com +233249135334 Noguchi Link, University of Ghana Campus, Legon
City Postal code Country Position/Affiliation
Accra Ghana Principal Investigator
Role Name Email Phone Street address
Public Enquiries Augustine Ankomah aankomah@popcouncil.org +233261524407 Yiyiwa Drive, Abelemkpe
City Postal code Country Position/Affiliation
Accra Ghana Doctoral Supervisor
Role Name Email Phone Street address
Scientific Enquiries Helen Habib helenhabib1@yahoo.com +233249135334 Noguchi Link, University of Ghana Campus, Legon
City Postal code Country Position/Affiliation
Accra Ghana Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the study after de-identification will be shared Study Protocol Beginning 3 months and ending 36 months following publication Anyone who wishes to access the data for scientific purposes. Interested parties may request access to data via email to hhhabib@st.ug.edu.gh. Interested parties will be required to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 12/05/2020 edit PROMOTING RESPECTFUL MATERNITY CARE FOR ADOLESCENTS: A QUASI-EXPERIMENTAL STUDY Promoting Respectful Maternity Care for Adolescents: A Quasi-experimental Study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 12/05/2020 edit PROMOTING RESPECTFUL MATERNITY CARE FOR ADOLESCENTS: A QUASI-EXPERIMENTAL STUDY Promoting Respectful Maternity Care for Adolescents: A Quasi-experimental Study
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/05/2020 edit Experimental Group, FACILITY BASED RESPECTFUL MATERNITY CARE TRAINING, One two-day event per facility, 2-days, The proposed intervention is a training module facilitated with the aid of a resource package adapted from the White Ribbon Alliance/ USAID “Respectful Maternity Care for Healthcare Workers: Tackling Disrespect & Abuse During Facility-Based Childbirth” project. Additionally, the structure and content of the module is influenced by evidence from previous studies and systematic reviews on mistreatment and RMC. This course will be presented in the format of presentations, case studies, role plays, discussions and evaluations. The content will cover the adolescent and their reproductive health rights, the GHS code of professional ethics, Nurses & Midwives Code of Conduct, definitions and typologies of mistreatment and RMC as well as their outcomes to the woman, neonate, professional and health system. The content will also cover the professionals’ role in the delivery of RMC. , 50, Experimental Group, Facility Based Respectful Maternity Care Training, One two-day event per facility, 2-days, The proposed intervention is a training module facilitated with the aid of a resource package adapted from the White Ribbon Alliance/ USAID “Respectful Maternity Care for Healthcare Workers: Tackling Disrespect & Abuse During Facility-Based Childbirth” project. Additionally, the structure and content of the module is influenced by evidence from previous studies and systematic reviews on mistreatment and RMC. This course will be presented in the format of presentations, case studies, role plays, discussions and evaluations. The content will cover the adolescent and their reproductive health rights, the GHS code of professional ethics, Nurses & Midwives Code of Conduct, definitions and typologies of mistreatment and RMC as well as their outcomes to the woman, neonate, professional and health system. The content will also cover the professionals’ role in the delivery of RMC. , 50,
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 12/05/2020 Correction to include minimum age of 10 years Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 13/05/2020 Undecided during time of initial submission. The investigator has decided to share IPD Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 13/05/2020 Undecided during time of initial submission. The investigator has decided to share IPD Individual participant data collected during the study after de-identification will be shared
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 13/05/2020 Undecided during time of initial submission. The investigator has decided to share IPD Beginning 3 months and ending 36 months following publication
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 13/05/2020 Undecided during time of initial submission. The investigator has decided to share IPD Anyone who wishes to access the data for scientific purposes. Interested parties may request access to data via email to hhhabib@st.ug.edu.gh. Interested parties will be required to sign a data access agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 13/05/2020 Undecided during time of initial submission. The investigator has decided to share IPD Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 13/05/2020 Start date has been changed due to interruption of preparations by COVID-19 related lockdown restrictions 01 Jun 2020 01 Jul 2020
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 13/05/2020 Received a doctoral grant for conduct of study WHO HRP Alliance, 20 Avenue Appia, Geneva, Geneva, , Switzerland, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 13/05/2020 Received a doctoral grant for the conduct of this study Helen Habib, PO BOX BT473, Tema, , Ghana, Primary Sponsor, Individual, WHO HRP Alliance, 20 Avenue Appia, Geneva, , Switzerland, Primary Sponsor, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 13/05/2020 Assigned supervisor Augustine Ankomah, 204 Yiyiwa drive, Accra, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 13/05/2020 Assigned academic supervisor Kwasi Torpey, Noguchi Link, University of Ghana Campus, Legon, Accra, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 13/05/2020 Assigned academic supervisor Ernest Tei Maya, Noguchi Link, University of Ghana Campus, Legon, Accra, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 19/06/2020 Re-schedule due to changes in timeline from stay at home orders 01 Jul 2020 03 Aug 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 19/06/2020 Re-schedule due to changes in timeline from stay at home orders 31 May 2021 31 Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/06/2020 Final approval letter received TRUE, Ghana Health Service Ethics Approval Committee, Barnes Road, Adabraka, Accra, 00233, Ghana, , 25 Mar 2020, +233302682709, info@ghsmail.org, 9837_10127_4737.pdf TRUE, Ghana Health Service Ethics Approval Committee, Barnes Road, Adabraka, Accra, 00233, Ghana, , 10 Jun 2020, +233302682709, info@ghsmail.org, 9837_10127_4737.pdf