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.: PACTR201808107241133 Date of Approval: 15/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Testing the added benefits of promoting early child development during pregnancy ultrasound
Official scientific title Testing the added benefits of promoting early child development during pregnancy ultrasound
Brief summary describing the background and objectives of the trial The innovation is to intervene early to promote child development as part of a scheduled health procedure (ultrasound) during pregnancy. Pregnancy is a period of heightened receptivity to influence among women and their partners. The intervention aims to provide information and support, to positively influence maternal health and wellbeing, breastfeeding and parent-infant interactions to promote a young child’s healthy growth and early development. This transformative period is a unique window for increasing parental investment in pregnancy wellbeing, birth and the early years of a child’s life. The novel elements are: 1) promoting early childhood development during pregnancy; 2) maximizing the benefits of an existing intervention (ultrasound) that is already planned to go to scale in South Africa by adding simple counselling messages to promote maternal wellbeing, parent-infant attachment and infant healthy growth and development, and 3) integrating an early childhood development intervention into an existing health service rather than trying to deliver and scale up a new intervention with additional human and system requirements.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Early child development and growth
Purpose of the trial Education /Training
Anticipated trial start date 03/12/2018
Actual trial start date 15/04/2019
Anticipated date of last follow up 31/07/2020
Actual Last follow-up date 31/08/2020
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 249
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
SB POC 1810 19664 Grand Challenges Canada Saving Brains
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 Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group One ultrasound scan at 20-24 weeks gestation (routine services) One ultrasound scan during pregnancy Routine services for women accessing antenatal care, including access to one additional ultrasound scan (without child development messages) at 20-24 weeks gestation 100 Dose Comparison
Experimental Group Early ultrasound and ECD One ultrasound scan at 20-24 weeks gestation with counselling and information on early child development One early ultrasound scan during pregnancy One ultrasound scan at 20-24 weeks gestation with counselling and support material, including ultrasound images and a personalised baby book 100
Experimental Group Early and late ultrasound and ECD Ultrasound scan at 20-24 weeks gestation and at 32-36 weeks gestation with counselling and support material Two ultrasound scans during pregnancy Two ultrasound scans at 20-24 weeks gestation and at 32-36 weeks gestation with counselling and support material, including ultrasound images and personalised baby book 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women attending antenatal clinic at Chris Hani Baragwanath Hospital Women aged 18 years and older Women resident in Soweto Women presenting before 24 weeks gestation Singleton pregnancy Women younger than 18 years of age If the referral to Chris Hani Baragwantath Hospital indicates major foetal abnormalities and/or severe maternal morbidities Multiple pregnancies Women not resident in Soweto Women presenting on or after 24 weeks gestation Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 65 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 19/11/2019 Human Research Ethics Committee Medical at the University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Phillip Tobias Building, 3rd Floor, 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Infant cognitive, communication, motor and social-emotional development Assessed when infant is 6 months of age
Secondary Outcome Infant growth - weight and length Assessed when infant is 6 weeks and 6 months of age
Secondary Outcome Breastfeeding practices Assessed when infant is 6 weeks and 6 months of age
Secondary Outcome Mother/father-interaction Assessed when infant is 6 months of age
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Hospital 26 Chris Hani Road Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada Saving Brains MaRS Centre, Suite 1720, West Tower 661 University Avenue Toronto Canada
DST NRF Centre of Excellence in Human Development University of the Witwatersrand Office 154 A, 1st Floor, Wits School of Public Health, 27 St Andrews Road, Wits Education Campus, Parktown Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MRC Wits Developmental Pathways to Health Research Unit Developmental Pathways for Health Research Unit, Corner College and Clinic Road, Chris Hani Baragwanath Academic Hospital Johannesburg 1862 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Wiedaad Slemming First floor, Wits School of Public Health, York Road, Parktown Johannesburg 2193 South Africa
Prof Shane A. Norris First floor, Wits School of Public Health, York Road, Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Linda M. Richter Linda.Richter@wits.ac.za 27117172382 DST-NRF Centre of Excellence in Human Development, first floor, Wits School of Public Health, York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Distinguished Professor and Director
Role Name Email Phone Street address
Public Enquiries Lethu Kapueja Lethu.Kapueja@wits.ac.za 27117172382 DST-NRF Centre of Excellence in Human Development, first floor, Wits School of Public Health, York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Centre Manager
Role Name Email Phone Street address
Scientific Enquiries Wiedaad Slemming Wiedaad.Slemming@wits.ac.za 27117172292 Division of Community Paediatrics, First floor, Wits School of Public Health, York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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