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.: PACTR202106905150440 Date of Approval: 25/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mobile phone intervention and Intermittent Preventive Treatment during pregnancy
Official scientific title Impact of the mobile phone as a complementary strategy for improving pregnant women’s access to Intermittent Preventive Treatment of malaria
Brief summary describing the background and objectives of the trial Over 30 million women living in malaria-endemic areas in sub-Saharan Africa become pregnant each year, with malaria causing every year an estimated >10,000 maternal and 75.000 – 200.000 infant deaths. Successful control of malaria in pregnancy (MiP) may save the lives of mothers and babies and is an essential part of antenatal care in endemic areas. WHO has developed guidelines for MiP control in sub-Saharan Africa consisting of a three-pronged approach: (i)- Prompt and effective management of clinical cases; (ii)- Long-lasting Insecticidal bed nets and (iii)- Intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP). Many African countries, including Burkina Faso, revised their policies to adopt this strategy. IPTp-SP consists of administering a full dose of SP at each antenatal care visit (ANC), starting early in the second trimester of pregnancy and given at least 1 month apart, with the desirable goal of 4 doses before delivery. However, this means the health system essentially waits for the women to attend a health facility they may not have easy access to or not use at all. In this context, there is an obvious need for new strategies to complement those existing in order to improve the ANC coverage. Therefore, we propose to test an innovative approach using the mobile phone as a means to promote the attendance of pregnant women to ANC. Thus, the novelty in this proposal is to increase the coverage of ANC attendance building on the use of an accessible technological tool (mobile phone) in Africa rural areas. We intend to set up a pragmatic randomized trial to evaluate the added value of the use of mobile phones as a complementary strategy for the improvement of IPTp coverage in areas of low ANC coverage in Burkina.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 02/11/2015
Actual trial start date 02/11/2015
Anticipated date of last follow up 02/11/2016
Actual Last follow-up date 07/01/2017
Anticipated target sample size (number of participants) 248
Actual target sample size (number of participants) 248
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile phone application Not applicable From the enrolment until delivery The intervention consisted of two systematic phone recalls, the 1st at one week before and the 2nd the day before the appointment for ANC visit even if the first call was a success 124
Control Group Standard care Not applicable From enrolment until delivery The routine strategy for ANC promotion based on sensitization at each contact of the pregnant woman with midwives in health care facilities 124 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery Gestational age at the first antenatal visit ≤ 20 weeks Ability to comply with study procedures for the entire length of the study Agreement to give signed informed consent Residence outside the study area or planning to move out in the following 12 months from enrollment Gestational age at the first antenatal visit > 20 weeks of pregnancy Known history of allergy to sulfa drugs Known history of severe renal, hepatic, psychiatric or neurological disease Participating in other intervention studies No access to a mobile phone in the family Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 47 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 03/12/2014 Comit ethique pour la Recherche en Sante du Ministre de la Sante
Ethics Committee Address
Street address City Postal code Country
03BP7035, Ouagadougou, Burkina Faso Ouagadougou 00226 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of IPTp4 per study group Delivery
Secondary Outcome Number of ANC visits per study group Number of anaemic women per study group Number of women infected by P. falciparum at delivery per study group Number of low birth weight per study group Regularity in the ANC visit appointment Delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Koudougou sub district Midwest of Burkina Faso Koudougou 00226 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization TDR Block 3510, Jalan Teknokrat 6 CyberJaya 63000 Malaysia Malaysia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre Hospitalier Universitaire Yalgado Ouedraogo 03BP7022 Ouagadougou 03, Burkina Faso Ouagadougou 00226 Burkina Faso Hospital
COLLABORATORS
Name Street address City Postal code Country
Michel Cot MERIT Mere et Enfant Face aux Infections Tropicales Institut de Recherche pour le Developpement Universite Paris Descartes Sorbonne Paris Cite Paris 75006 France
Blaise Sondo Institut Africain de Sante Publique Ouagadougou 00226 Burkina Faso
Achille Massougbodji Institut de Recherche Clinique du Benin Abomey Calavi 00229 Benin
Halidou Tinto Nanoro clinical Research centre Ouagadougou 0226 Burkina Faso
Jean Zida Centre Hospitalier Universitaire Yalgado Ouedraogo Ouagadougou 00226 Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Smaila Ouedraogo smaila11@yahoo.fr +22676208609 03BP7022 Ouagadougou 03
City Postal code Country Position/Affiliation
Burkina Faso 00226 Burkina Faso Associate professor in Epidemiology University Joseph Ki ZERBO
Role Name Email Phone Street address
Scientific Enquiries Manfred Accrombessi accrombessimanfred@yahoo.fr 0022966033138 C1640 Aibatin 2 Cotonou
City Postal code Country Position/Affiliation
Cotonou 00229 Benin Research fellow London School of Hygiene and Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Maurice Sarigda maursarigda@yahoo.fr +22670282775 Ouagadougou,
City Postal code Country Position/Affiliation
Burkina Faso 00226 Burkina Faso Sociologist Ministry of Health PADS
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data is available from the study principal investigator (Dr. Smaila Ouedraogo; Email: smaila11@yahoo.fr) upon reasonable request. Study Protocol No date limitation from the publication of results Only for research purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 18/06/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/06/2021 Result - 18/06/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information