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.: PACTR202212611709509 Date of Approval: 21/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Addressing hidden barriers to institutional deliveries – a key intervention for reducing maternal mortality in poor rural Zambia
Official scientific title A Community intervention trial for improved health facility deliveries in rural Zambia: A step towards reducing maternal mortality
Brief summary describing the background and objectives of the trial Zambia is one of the countries with a high maternal mortality ratio currently at 252 deaths per 100 000 live births. WHO has shown that institutional delivery by a skilled birth attendant is the most effective way to reduce maternal mortality in developing countries. We conducted a one-year prospective community intervention trial in Monze, Zambia comprising pregnant women at any gestation allocated to the intervention and control arms. Women in the intervention arm received antenatal care (ANC) health education followed by a non-monetary incentive in the form of a mother-baby delivery pack containing two napkins, a bottle of Vaseline®, baby soap, a pair of delivery gloves, a baby vest, a wrappper and an insecticide treated mosquito net (ITN)) given to pregnant women when they arrived at the health facility for delivery. Participants in the control arm continued with routine ANC services. Primary objective: To determine the effect of provision of a non-financial incentive on institutional deliveries in Monze, Zambia. Secondary objectives were to: 1) assess women's delivery preparedness; 2) determine postnatal care service utilisation by mother and baby; 3) determine under-five clinic service utilisation, 4) assess pregnant women's knowledge about pregnancy danger signs
Type of trial CCT
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 To test the effect of provision of a non-financial incentive on institutional deliveries in Monze, Zambia.
Anticipated trial start date 01/01/2014
Actual trial start date 01/01/2014
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 5000
Actual target sample size (number of participants) 3882
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 Intervention arm Non-financial incentive in the form of a mother-baby delivery pack containing two napkins, a bottle of Vaseline®, 1 baby soap, 1 pair of delivery gloves, 1 baby vest, 1 chitenge (wrapper) and 1 insecticide treated mosquito net (ITN)) which were given to pregnant women at the time of delivery in a health facility. The control arm continued to receive routine standard ANC services. 12 months The one year trial was conducted in Monze, Zambia, from 1st January to 31st December 2014. The district was stratified into two rural regions separated in the middle by the town centre. The region on the western side was allocated the intervention arm; the region on the eastern side as the control arm. A total of eight health facilities were included in each arm. The inclusion criteria for the health facilities was that a health facility conducted deliveries. The town centre (district administrative centre), with a number of urban health facilities and one referral hospital, served as a buffer between the intervention and control arms. The physical separation of the research arms prevented the spill over of relevant information on the non-financial incentives package. Given the transport challenges, it was deemed unlikely for an expectant mother to by-pass the more than 30km buffer and go for delivery in either of the study health facilities in the opposite arm. Both intervention and control regions had similar health facilities, in terms of the location (rural), size and the catchment population-both had similar socio-economic and demographic profiles. Intervention arm: Pregnant women in the intervention received a non-financial incentive in form of a mother-baby delivery pack. In addition to the health education provided during routine ANC visits, pregnant women in the intervention arm were provided with health education sessions. 2684
Control Group Control arm Routine Antenal care services 12 months Pregnant women in the control arm continued with the routine antenatal care services 1198 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included in the study, women needed to be: • Pregnant at any gestation and age. Ascent was obtained from the parents or legal guardians for the participants who were aged below 18 years • Residing in the study site catchment area for at least 3 months. Pregnant women who were new in the area were excluded from the study • Willing to participate New in the area (less than 3 months) Women with pregnancy complications Adult: 19 Year-44 Year 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 10/09/2013 Tropical Disease research Centre
Ethics Committee Address
Street address City Postal code Country
Ndola Ndola 71769 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was the difference in the mean number of institutional deliveries in the intervention and the control regions over a one-year period from 1st January to 31st December 2014. baseline and Endline
Secondary Outcome The secondary outcome measures were 1) delivery preparedness; 2) postnatal care service utilisation by mother and baby; 3) under-five clinic service utilisation, 4) knowledge about pregnancy danger signs Baseline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Monze district Zambia Livingstone Lusaka road Monze Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
WHO UNICEF MOH Lusaka Lusaka Zambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor WHO Lusaka Lusaka Zambia WHO country office
Primary Sponsor UNICEF Lusaka Lusaka Zambia UNICEF
Secondary Sponsor Zambian MOH Ndeke house Lusaka Zambia Zambian MOH
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victor Mukonka vmukonka@gmail.com +260977844754 Lusaka
City Postal code Country Position/Affiliation
Lusaka Zambia Associate Professor Levy Mwanawasa Medical University School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Cephas Sialubanje csialubanje@yahoo.com +260977441273 Lusaka
City Postal code Country Position/Affiliation
Lusaka Zambia Dean School of Public Health Levy Mwanawasa Medical University Lusaka Zambia
Role Name Email Phone Street address
Public Enquiries Dr Sarai Malumo malumos@who.int +260977844754 Lusaka
City Postal code Country Position/Affiliation
Lusaka Zambia Reproductive Health Specialists WHO
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data have been anonymised Informed Consent Form,Statistical Analysis Plan,Study Protocol Data are available Data are available upon request from the principal investigator with permission of the TDRC ethics review board.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/12/2022 Result - 21/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information