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.: PACTR202009861550402 Date of Approval: 21/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of the Pregnancy and Newborn Diagnostic Assessment system on antenatal care quality in Burkina Faso: a cluster randomized controlled trial
Official scientific title Effectiveness of the Pregnancy and Newborn Diagnostic Assessment system on antenatal care quality in Burkina Faso: a cluster randomized controlled trial
Brief summary describing the background and objectives of the trial Although many women attend antenatal care, maternal mortality has not been significantly reduced in developing countries. The quality of care offered to women during ANC is often low and not conducive to detecting complications. The Pregnancy and Newborn Diagnostic Assessment (PANDA) system has emerged to improve the quality of ANC care. A feasibility study was therefore conducted in rural Burkina Faso in 2016 in the health district of Koupéla. This study aims to test the effectiveness of this system on the quality of ANC.
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 THE PANDA SYSTEM
Anticipated trial start date 04/05/2020
Actual trial start date 13/07/2020
Anticipated date of last follow up 17/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 700
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group THE PANDA SYSTEM 6-7 months The women enrolled will attend a number of ANC visits along with the pregnancy according to WHO recommendations and the stage of pregnancy at the time of the enrollment. A random ID number will be assigned to each woman, to which their clinical data and test results will be linked. ANC visits will start with the collection of social/personal data and medical history and then screening tests (HIV, HPV syphilis, malaria, hemoglobin, glucose), as well as other measurements (temperature, weight, height, blood pressure, uterine height), will be conducted. Once the screening is completed, the PANDA team will proceed to health education, focusing on maternal and newborn care and birth preparedness as well as family planning. On a daily basis, data and test results will be sent to the medical unit, for data verification and personalized intervention plans in order to optimize the management of pregnancies and childbirths and to ensure appropriate care for high-risk pregnancies. At each antenatal visit, all women in the experimental group will be managed by using the PANDA system 300
Control Group Routine Care 6-7 months Routine care 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Pregnant woman with a pregnancy of fewer than 16 weeks of gestational age - Belonging to the health facility's sanitary area - Have plan no travel during the next 6-7 months - Not included in any other ongoing research - no need to refer for any reason in advance - Intending to give birth in the health center. Non-consenting woman Refusal to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 50 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 25/03/2020 Burkina Faso ethic committee for health research
Ethics Committee Address
Street address City Postal code Country
Not applicable Ouagadougou 7009 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quality of antenatal care ANC Each ANC from inclusion until delivery
Secondary Outcome Pregnant women satisfaction (waiting time, interpersonal relationships between women and health workers, perceptions of the quality of care) Each ANC
Secondary Outcome Women's knowledge on birth preparedness and complication readiness First trimester and before delivery
Secondary Outcome Utilization of maternal health services (proportions of pregnant women who will have achieved at least 4 ANC) After Delivery
Secondary Outcome Men's involvement in maternal health Each ANC
Secondary Outcome Postpartum family planning utilization at 6 weeks After delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Koupela District Koupela, RN12, Centre-Est Koupela Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
Enfants du Monde Suisse Route de Ferney 150 Genevia 1211 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Enfants du Monde Route de Ferney 150 Genevia 1211 Switzerland Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Initiative Prive Communautaire pour la sante et la riposte au VIH SIDA au BF Rue Jacqueline Ki-Zerbo Ouagadougou Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seni Kouanda senikouanda@gmail.com +22625363215 Rue Weem Doogo
City Postal code Country Position/Affiliation
Ouagadougou Burkina Faso Principal Investigator
Role Name Email Phone Street address
Public Enquiries Abou Coulibaly samsoncoul@gmail.com +22625363215 Rue Weem Doogo
City Postal code Country Position/Affiliation
Ouagadougou Burkina Faso Researcher
Role Name Email Phone Street address
Scientific Enquiries Abou Coulibaly samsoncoul@gmail.com +22625363215 Rue Weem Doogo
City Postal code Country Position/Affiliation
Ouagadougou Burkina Faso Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will make available all the data at the end of the trial. We have planned to write scientific articles which will be published in scientific journals Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol All the documents will be available upon a reasonable request 12 months after the end of the study. From July 2021 to June 2022 Email to the principal investigator
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