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.: PACTR202305694761480 Date of Registration: 09/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Enhancing Nutrition and Antenatal Infection Treatment evaluation
Official scientific title Effect of Enhancing Nutrition and Antenatal Infection Treatment intervention on birth weight in Ethiopia: A cluster Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Enhancing Nutrition, and Antenatal Infection Treatment (ENAT) intervention was implemented in Ethiopia to improve newborns birth weight by strengthening the contents and quality of Antenatal care (ANC). This study assesses the impact of the ENAT intervention on birth weight (BW), as a primary outcome. Secondary outcomes include pre-term birth, still birth, pregnancy weight gain, and maternal anaemia. It also examines the quality of ENAT program implementation in order to inform refinements to intervention design and delivery. We conducted a cluster-randomized controlled trial in 22 clusters (health centers), randomized equally between 11 intervention and 11 control clusters. The evaluation enrolled and followed pregnant women from ANC booking to end of pregnancy or lost-to-follow-up. The primary outcome of this evaluation was mean birth weight, and the incidence of low birth weight (LBW) was the secondary outcome.
Type of trial RCT
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 Improve newborns birth weight by strengthening the contents and quality of Antenatal care, especially point-of-care testing for maternal infections.
Anticipated trial start date 15/03/2021
Actual trial start date 15/03/2021
Anticipated date of last follow up 10/07/2022
Actual Last follow-up date 10/07/2022
Anticipated target sample size (number of participants) 4782
Actual target sample size (number of participants) 6637
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ENAT Pregnant women receive the ENAT intervention from ANC booking to end of pregnancy 16 months The ENAT intervention was implemented in 65 health centers and their communities in the three zones. ENAT was a bundle of interventions that include: strengthening/introducing point-of-care diagnostics technology for screening of maternal infections and treatment, training of health care providers on basic antenatal care services provision including comprehensive counseling, screening for infection and treatment, and provision of preventive care, strengthen/introduce a system for tracking pregnant women to verify and support continuity of care, i.e., adherence to ANC service. The intervention also strengthened existing community activities to identify pregnant women and improve the early initiation of pregnant women to ANC services. The main intervention activities can be summarized as follows: • Clinical skills strengthening training: The training focused to ensure the improvement of the quality of ANC services that included ANC skills-building trainings for midwives, nurses, and laboratory technicians. • Point of Care (POC) Testing Training: ENAT strengthened the availability and capacity of PoC tests, including asymptomatic bacteriuria (ASB), Syphilis, Hemoglobin and others. Laboratory technicians and technologists from selected Universities and regional laboratories conducted periodic supportive supervision and quality assurance in the project health centers. • Availing essential equipment and supplies: The project health centers were supplied with necessary urine dipsticks, syphilis tests, and hemoglobin tests, essential ANC equipment, including BP apparatus and weighing scales. As part of the regular monitoring of health facilities, the ENAT field team conducted a periodic assessment of essential commodities and supplies to inform project-supported procurement. • Improving nutrition intervention: ENAT introduced different strategies to prevent nutritional disorders during pregnancy. Some of the interventions were providing screening pregnant mothers for 3445
Control Group ENAT Pregnant women received the Ethiopia Government's routing ANC services from ANC booking to end of pregnancy 16 months In the control health centres, the pregnant women received the routine Ethiopia Government’s (EG's) ANC, which is based on the country's national ANC guideline. 3192 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The eligibility criteria for the pregnant women to be included in this study was that they must be enrolled into the study at their first ANC booking, and had a confirmed positive pregnancy test. None Adult: 18 Year(s)-44 Year(s),New born: 0 Day-1 Month 15 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 01/03/2021 Amhara region public health institute APHI
Ethics Committee Address
Street address City Postal code Country
APHI office, Bahirdar, Amhara Region BahirDar 641 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Low Birth weight less than 2500 grams within 48 hours of delivery
Primary Outcome Mean Birth Weight Within 48 hours of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abomssa Health center Abomssa Woreda rural facility Ethiopia
Kerssa Health Center Kerssa Woreda rural facility Ethiopia
Gobessa Health center Gobessa Woreda rural facility Ethiopia
Golja Health center Goja buna Woreda rural facility Ethiopia
Chole health center Chole Woreda rural facility Ethiopia
Iteya health center Iteya Woreda rural facility Ethiopia
Lode Jameta Health center Lode Woreda rural facility Ethiopia
Sire Health center Sire Woreda rural facility Ethiopia
Addis Zemen Health Center Addis Zemen Woreda Rural facility Ethiopia
Gassey Health center Gassey Woreda rural facility Ethiopia
Amejaie Health Center Amejaie Woreda rural facility Ethiopia
Kimir Dengay Health center Kimir Dengay Woreda rural facility Ethiopia
Hamusit Health center Hamusit Woreda rural facility Ethiopia
Liben Hidessa Health center Liben-Baso Woreda rural facility Ethiopia
Durbete Health center Durbete Woreda rural facility Ethiopia
Birkata Health center Birkata Woreda rural facility Ethiopia
Merawit Health center Merawi Woreda rural facility Ethiopia
Kuch Health center Kuch Woreda rural facility Ethiopia
Dembecha Health center Dembecha Woreda rural facility Ethiopia
Wad Health center Wad-Chole Woreda rural facility Ethiopia
Jiga Health center Jiga-Dembecha Woreda rural facility Ethiopia
Shindy Health center Shindy-Wenbirma Woreda rural facility Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Children Investment Fund Foundation 7 Clifford Street London, W1S 2FT United Kingdom London W1S 2FT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Children Investment Fund Foundation 7 Clifford Street London, W1S 2FT United Kingdom London United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yared Mekonnen yared@melaresearch.com 00251935402039 Figa Appt 3, Lemi-Kura sub-city, Addis Ababa, Ethiopia
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Managing Director
Role Name Email Phone Street address
Scientific Enquiries Mihretab Salasibew MSalasibew@ciff.org 00447766217229 7 Clifford Street, London, W1S 2FT, United Kingdom
City Postal code Country Position/Affiliation
London United Kingdom Director CIFF
Role Name Email Phone Street address
Public Enquiries Endeshaw Wolde endeshaw@gmail.com 00251913488041 Ayat Condo app 15, Yeka Sub-city, Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All study participants data will be available after deidentfication Study Protocol May 2023-December 2023 Open access to deidentified data set, which can be used for any analysis related to ENAT
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/04/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/04/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information