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: pactr.samrc.ac.za
Trial no.: PACTR202307796091075 Date of Approval: 17/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation of midwives-led continuous labor support care to improve immediate intrapartum outcomes at four district hospitals in Ethiopia 2023. Knowledge to Action framework.
Official scientific title Midwives-led continuous labor support care to improve immediate intrapartum outcomes at four district hospitals in Ethiopia 2023. Knowledge to Action framework.
Brief summary describing the background and objectives of the trial Childbirth is a watershed moment in a woman’s life, with far-reaching consequences for her physical and psychological well-being, as well as that of her newborn (1). Each year, approximately one million stillbirths occur during labor. The majorities of these stillbirths occur in low and meddle-income couriers and are linked to insufficient, delayed or non-existence of continuous labor support care. The low proportion of intrapartum stillbirths in high-income countries suggests that they are largely avoidable with quality and continuing midwives-led care (2). To evaluate the effect of midwife-led continuous labor support care on immediate intrapartum outcomes at four district hospitals in Ethiopia 2023.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female,HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 29/08/2023
Actual trial start date 24/08/2023
Anticipated date of last follow up 13/03/2024
Actual Last follow-up date 11/07/2023
Anticipated target sample size (number of participants) 610
Actual target sample size (number of participants) 610
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Continuing labor supportive care For each primigravida women, every 30 minutes will be given the care The intervention will be given starting from activ labour initiation of the primi gravida women. Four senior midwives will provide two days of midwife-led continuing labor care training for 36 maternity ward midwives and newly graduated midwives, as well as four data collectors and supervisors. Continuing labor supportive care (massaging the woman's back, cold therapy, encouraging the mother to walk during labor, dynamic birth positions, and the presence of birth companions) will be taught and demonstrated to midwives during the sessions in conjunction with baseline findings. The routine care will be performed in the control group. The intervention and control primigravida women with singleton pregnancy, normal fetal presentation, and ages 18 to 49 years old at each hospital will be included. Women with medical problems will be excluded. The participants will be randomly assigned to the intervention and control group with a ratio of 1:1. 155
Experimental Group continouse labor suport care For each primigravida woman, ongoing labor support will be provided for the intervention groups beginning with the first stage of active labor. While the regular care will continue for the controlled group. From the active first stage of labor till the delivery of the fetus, the following labor support care will be provided. Continuing labor supportive care (massaging the woman's back, cold therapy, encouraging the mother to walk during labor, dynamic birth positions, and the presence of birth companions) will be taught and demonstrated to midwives during the sessions in conjunction with baseline findings. 155
Control Group usual care It will keep as usual. It will keep till the intervention groups will be completed. the usual labour and delivery care will be keep as usual. 155 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primigravida, Singlton, has no medical problems. multigravida twin pregnancy Adult: 19 Year-44 Year 18 Year(s) 49 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
No 10/08/2023 Institutional review board of University of Gondar College of Medicine and Health Science Comprehensive Specialized Hospital
Ethics Committee Address
Street address City Postal code Country
Gondar Gondar 0196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome stillbirth, birth duration, level of birth pain, fear, anxiety, and rate of newborn death It will be determined immediately after birth.
Secondary Outcome Acceptability of midwives-led care, depression, It will be measured after the intervention will be commpleted.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Zemen hospital Gondar Gondar 196 Ethiopia
Kolla dipa hospital Gondar zuria kolla dipa 0196 Ethiopia
Dabat hispital north Gondar Dabat 0196 Ethiopia
Debark hospital Debark Debark 0196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Laerdal Foundation Sentrum 4003 Stavanger 0556 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laerdal Foundation Sentrum 4003 Stavanger 0556 Norway Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mengstu Asaye mengstum@gmail.com +251918037041 Gondar
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia Assistant Professsor and PhD holder
Role Name Email Phone Street address
Public Enquiries Mengstu Asaye mengstum@gmail.com 0918037041 Gondar
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia PhD
Role Name Email Phone Street address
Scientific Enquiries Mengstu Asaye mengstum@gmail.com 09180307041 Gondar
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia PhD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the articles, after deidentification (text,tables,figures, and appendices). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning of 3 months and ending 5years following of artticles published. https://www.linkedin.com/in/mengstu-asaye-56198750/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.linkedin.com/in/mengstu-asaye-56198750/ 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