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.: PACTR202310532830947 Date of Approval: 03/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect Of Midwife-Led Continuum Of Care On Adverse Outcome Of Pregnancy
Official scientific title The Effect Of Midwife-Led Continuum Of Care On Adverse Outcome Of Pregnancy
Brief summary describing the background and objectives of the trial Midwifery-led continuum of care, an approach which is already widely practiced in developed nations ; however, it is a relatively new approach in lower-income countries. In midwifery-led continuum of care, a midwife who is well known by their client, provides the care for a low-risk pregnant woman throughout antenatal care, delivery, and the postnatal period, instead of being cared for by various medical staff . The primary focus of midwifery-led care is on supporting a healthy physiological pregnancy and labor, and empowering women to give birth naturally with little to no regular intervention. Therefore, this study aims to evaluate and examine the effect of midwifery-led continuum of care for preventing adverse outcome of pregnancy in Sidama region, Ethiopia.
Type of trial Non-Randomised
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 Prevention
Anticipated trial start date 30/10/2023
Actual trial start date 30/10/2023
Anticipated date of last follow up 30/07/2024
Actual Last follow-up date 30/07/2024
Anticipated target sample size (number of participants) 304
Actual target sample size (number of participants) 304
Recruitment status 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
Single Group Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Midwifery led continuum of care Team of 4-6 midwives for each intervention sites The intervention is planned for six months Midwife-led continuum of care, defines as care by a named midwife for each pregnant women, who provides care throughout the pregnancy, birth and postnatal period. The study will have a preparation and intervention phase. In the preparatory phase, discussion will be arranged with relevant stakeholders such as regional health bureau and Hospital managers. The standard training manual will be amended, including a standardize checklist for monitoring of the intervention. Midwives will be assigned for Midwifery-led continuum of care and recruited on a voluntary basis. All Midwives will receive training on the concept and competency of the intervention for one month. The focus of the training will be clinical, problem solving and decision-making skills. The Training topics will include basic concepts of Antenatal care; pregnancy care; childbirth care and postnatal maternal care. The aim of the training will be to prepare the midwives in the intervention site for early detection and management for low-risk mothers using national midwifery care process and how to connect with obstetricians when complication happen beyond their scope of competency. After the preparation phase, the trained midwives will be deployed for six months in the intervention hospitals. In the interventional group, at the initial visit, adolescent women will be informed about the midwifery-led continuum of care, its advantage and how it will be implemented. They will then be aligned to a volunteer Midwife participant for the duration of the study. The detail of the midwifery-led continuum of care and follow-up schedule will be explained in detail in a private room for 10-15minutes. They will attend three visits at less than 24 weeks, 28-32 weeks and 36-38 weeks. Then they will be given an identification code and informed of the duration and frequency of midwifery-led care. To ensure participants follow-up, the assigned midwives will remind them two days before the appointment by phone. 239
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) booked for governmental maternity care at the study hospital b) 24 weeks pregnant or less c) single live fetus at time of recruitment (d) women without any complication Residence outside of the hospital catchment area Women want to get care outside the intervention Multiple pregnancy History of medical and obstetric complications. Adult: 19 Year-44 Year 16 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
Yes 07/11/2022 Hawassa University College of Medicine and Health Science Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Hawassa, Sidama Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome spontaneous vaginal birth, and preterm birth Intrapartum period
Secondary Outcome Cesarean section, Instrumental delivery, PROM, APH, PPH, Episiotomy, low birth weight, Apgar during 1st and 5th minute , Early neonatal death, Maternal death are the secondary outcomes. Intrapartum, and Early post-partum period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hawassa Hawassa, Sidama Hawassa 1560 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
None Hawassa Hawassa 1560 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NA NA NA NA Ethiopia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rekiku Fikre frekiku@yahoo.com +251911545989 Hawassa
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Jessica Gubbles jessica.gubbels@maastrichtuniversity.nl +31433882182 Maastrictus
City Postal code Country Position/Affiliation
Maastrictus 321 Netherlands supervisor
Role Name Email Phone Street address
Public Enquiries Sanne Gerards sanne.gerards@maastrichtuniversity.nl +3195730274920 Maastrictus
City Postal code Country Position/Affiliation
Maastrictus 321 Netherlands supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol We will share it from Aug 2024 to Sep 30/2024. Publication
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