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.: PACTR202306721999803 Date of Approval: 13/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of communication via social media (WhatsApp) on coverage and outcome of WHO recommended interventions during antenatal care for a positive pregnancy experience
Official scientific title Effect of communication via social media (WhatsApp) on coverage and outcome of WHO recommended interventions during antenatal care for a positive pregnancy experience
Brief summary describing the background and objectives of the trial Low coverage of essential interventions during pregnancy is a main contributor of maternal and neonate morbidity ratio that stand at 361 per 100000 live births and 17 per 1000 live births respectively, far from the expected level (70 per 100000 live births for maternal mortality rate and 12 per 1000 live births for neonate mortality rate). Several strategies and interventions have been implemented to address that insufficient coverage of the recommended interventions with more or less effectiveness, including provider’s checklist, community-based interventions, midwife-led continuity of care, task-shifting. The current body of literature does not adequately address the effectiveness of communication via WhatsApp on the interventions targeting PW. Giving the high coverage of WhatsApp platform utilization in Cameroon, the integration of this application to the routine pregnancy care can be a great opportunity to improve coverage and outcome of the WHO recommended interventions during antenatal care. The main objective of this study is to assess the effect of communication via WhatsApp on the coverage and outcome of WHO recommended interventions during antenatal care for a positive pregnancy experience.
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 Communication via social media
Anticipated trial start date 01/08/2023
Actual trial start date
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WhatsApp group Bi-weekly antenatal care messages in addition to routine antenatal care 20 weeks In addition to routine pregnancy care offered by health facility, participants intervention group will be included in an interactive WhatsApp group where they will be allowed to send text, voice and emoji messages. That WhatsApp group will also contain three health personnel (two midwifes and one gynecologist) who will be able to give orientations, response to question or worries raised by participants. Participants will be encouraged to post in the group their questions, worries, challenges and share their experiences throughout the study. PW will also be encouraged to react to the post of health personnel and the ones of other PW. At the initial phase of the intervention, selected health education (videos, text messages) will be posted in the group and on the investigator WhatsApp status bi-weekly, on Monday morning. Subsequently, videos and messages will be posted on the emerged topics from the discussion in the groups. Each PW included in the study will be requested to save the investigator’s number so that they can have access to the investigator WhatsApp status. Exposition to the intervention will be documented by determining the proportion of participants who have seen/read selected video/test message. 175
Control Group Routine antenatal care only Routine Pregnancy period Routine ANC care according to the national policies 175 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. PW coming for the first ANC at the hospital 2. Having an android phone 3. Being a WhatsApp user Pregnant women who refuse to participate to the study Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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
No 08/06/2023 National Ethics Committee for Human Health Research
Ethics Committee Address
Street address City Postal code Country
Yaounde-Cameroon Yaounde Yaounde Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of antenatal care visit End of the pregnancy
Primary Outcome Prevention and management of malaria Each antenatal care visit
Primary Outcome Iron supplementation End of the pregnancy
Secondary Outcome Pregnancy related anxiety 3 and 6 months after enrolment
Secondary Outcome Pregnancy experience End of the pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Medical Jean Zoa Nkoldongo Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Yaounde Yaounde Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Djouma Nembot Fabrice Yaounde Yaounde Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Jerome Ateudjieu Yaounde Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Djouma Nembot Fabrice nembotfabrice2009@yahoo.fr 00237674502863 Yaounde
City Postal code Country Position/Affiliation
Yaounde Cameroon PhD Student University of Dschang
Role Name Email Phone Street address
Public Enquiries Djouma Nembot Fabrice nembotfabrice2009@yahoo.fr 00237674502863 Yaounde
City Postal code Country Position/Affiliation
Yaounde Cameroon University of Dschang
Role Name Email Phone Street address
Scientific Enquiries Ateudjieu Jerome jateudj@yahoo.fr 00237677624351 Yaounde
City Postal code Country Position/Affiliation
Yaounde Cameroon Supervisor University of Dschang
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes At the end of the study, individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices) will be shared. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of the study completion date IPD will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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