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.: PACTR202310664101480 Date of Approval: 16/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Reducing unnecessary cesarean section rate in Ethiopia
Official scientific title Non-medically indicated cesarean section among nulliparous pregnant women: to reduce unnecessary cesareans in Ethiopia using a randomized controlled trial
Brief summary describing the background and objectives of the trial Despite the short- and long-term risks associated with cesarean sections, the proportion of births by surgical intervention continues to increase beyond the level of obstetrics recommendations. This cluster-based randomized controlled trial aims to develop, implement, and evaluate the effectiveness and feasibility of educational and support programs targeted at pregnant women together with evidence-based guidelines and clinical algorithms targeted at health providers on reduction of non-medically indicated cesarean sections among nulliparous women at public health institutions of Ethiopia. The study will also implement a mixed-method, baseline study to estimate the current rate of cesarean sections and identify factors contributing to its rapid rise among nulliparous women delivered at public health institutions. A post-intervention outcome measurement study will also be applied to evaluate the effectiveness and feasibility of the intervention. Additionally, we will assess the pregnant women and health providers' level of satisfaction towards the intervention. The technical content of the intervention will be primarily based on WHO's recommendations for reducing non-medically indicated CS. The study will be conducted at eight randomly selected public hospitals in Ethiopia. Nulliparous pregnant women who have no identified medical contraindications to vaginal delivery and plan to give birth at the selected hospitals will be included in the study. Evidence from this study will enhance understanding of the possible personal and provider-related factors for the increment of unnecessary obstetrics intervention and their outcomes. Additionally, a feasible evidence-based guideline and clinical algorithms model for the reduction of non-medically indicated CS will be developed for potential policy implications and national scale-up.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Base line
Disease(s) or condition(s) being studied Caesarean section ,Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2024
Actual trial start date
Anticipated date of last follow up 01/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 938
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Educational and Psychosocial support program together with utilization of evidence based guideline NA Throughout pregnancy and childbirth Health education and psychosocial support will be provided for all pregnant women and their partner or support person throughout their ANC visits, aiming to empower them to make informed decisions on their mood during childbirth and increase their level of awareness about childbirth options. Similarly, an evidence-based guideline and clinical algorithm will be developed for the main indications of caesarean section identified in the baseline study. Training on the use of this guideline will be provided for all health professionals involved in the CS decision-making process. Handouts and posters will be prepared and posted in the delivery room. Furthermore, monthly seminars on current trends and recommendations of caesarean section will be provided for health professionals. 469
Control Group Routine Standard care NA Throughout the pregnancy and childbirth period Pregnant women assigned to the control group will be provided with regular antenatal care and delivery services as per usual practices in the hospitals. Healthcare providers who provide antenatal and childbirth services will not undergo any additional intervention or training; they will adhere to the routine procedures. Healthcare providers involved in decisions related to the mood of childbirth will follow the usual practices in the hospitals without any intervention or training. 469 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For the hospitals: 1. minimum of 150 caesarean sections for nulliparous women per year 3. The permanent availability of emergency caesarean section 4. The absence of current or recent interventions targeted at the indications and interventions associated with caesarean section 5. Willingness to participate in the study is materialized by a written and signed ward agreement by the hospital director and the head of the maternity unit 6. District or regional hospital For pregnant women All nulliparous pregnant women who have no identified medical contraindications to vaginal delivery, who have had antenatal follow-up, and who are planning to give birth at either of the selected health institutions will be included in the study. Women who are over 18 but less than 35 years of age and have no existing medical or obstetric indications such as high blood pressure, diabetes, hyperthyroidism, or habitual abortion, and whose pregnancy signs are stable, will be invited to participate in this study. For the health professionals: All health professionals who provide antenatal care and childbirth services, and who are involved in the decision-making process for the mood of childbirth will be included in the study. For the hospitals: 1. Teaching hospitals 2. Private hospitals For the patients: 1. Women who have known psychiatric and medical diseases, multiple pregnancies, or pregnancies complicated by congenital abnormalities 2. Women started antenatal care in the hospitals but whose caesarean section was performed in another hospital Adult: 19 Year-44 Year 18 Year(s) 35 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 20/07/2023 Woldia University Inisttitutional Review Board
Ethics Committee Address
Street address City Postal code Country
Woldia University Woldia 400 Ethiopia
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 01/08/2023 Amhara Public Health Institute
Ethics Committee Address
Street address City Postal code Country
Shmbit Kebele 13 Bahr Dar 47 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The effect of the intervention will be measured by the change in the rate of non-medically justified caesarean sections among nulliparous women between the periods before and after the intervention. The caesarean section will be defined as Non-medically indicated if it was done for indications that don’t fulfil the clinical algorithm for CS decision-making. In addition caesarean section done for women and provider preference will also be considered as Non- medically indicated CS. Data on caesarean sections will be collected for one year before the intervention period and 6 months after the intervention period.
Secondary Outcome The secondary outcomes of the study will be the factors and indications of non-medically indicated CS. Feto-maternal outcomes of CS and vaginal delivery in nulliparous pregnant woman. Data will be collected for one year before the intervention period and 6 months after the intervention period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bishoftu General Hospital Kebele- 04 Bishoftu Ethiopia
Felegehiwot Comprehensive Specialized Hospital Shmbit Kebele 13 Bahr Dar 47 Ethiopia
Dil Chora General Hospital 10a Street Dire Dawa Ethiopia
Ras Desta Damtew Memorial Hospital Ras Desta Damtew Street Addis Ababa Ethiopia
Sabian General Hospital Kebele 02,Sebategna Dire Dawa Ethiopia
Shashemene Referral Hospital Kuyera Dedeba Shashemen 027 Ethiopia
Woldia Comprehensive Specialized Hospital Piassa Woldia Ethiopia
TIruneshi Beijing General Hospital Meshualeka Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Woldia University Woldia University Woldia Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Woldia University Woldia University Woldia Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mulugeta Arage mulewodaje@gmail.com +251924918237 Woldia university
City Postal code Country Position/Affiliation
Woldia Ethiopia Woldia University
Role Name Email Phone Street address
Public Enquiries Mulugeta Arage mulewodaje@wldu.edu.et +251924918237 Woldia University
City Postal code Country Position/Affiliation
Woldia Ethiopia Woldia University
Role Name Email Phone Street address
Scientific Enquiries Mulugeta Arage mulewodaje@gmail.com +251924918237 Woldia University
City Postal code Country Position/Affiliation
Woldia Ethiopia Woldia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trial, after deidentification, study protocol, and clinical study report will be made available following article publication Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication up to 5 years. Qualified researchers doing scientific research may seek access to the trial IPD; access will be granted following assessment and approval of a study proposal, statistical analysis plan (SAP), and execution of a data sharing agreement (DSA)
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