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.: PACTR201406000841188 Date of Approval: 03/06/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Antenatal health promotion via short message service at a Midwife Obstetrics Unit in South Africa: a mixed methods study
Official scientific title Health SMSs informing community: Can an SMS based antenatal health promotion address language barriers and advance the right of access to health information and effective health care ¿ and if so, how?
Brief summary describing the background and objectives of the trial Antenatal care is important for the health of a pregnant woman and her unborn baby. In South Africa, where cellphone penetration is high, this study aimed to increase antenatal health knowledge by disseminating text messages about clinic procedures and how to be healthy during pregnancy. Participants recruited were pregnant women attending a primary health care facility in Cape Town. A controlled clinical trial was carried out where the intervention group (n = 102) received text messages staggered according to the week of pregnancy at the time of recruitment and according to language preference (English, Xhosa or Afrikaans). The control group (n = 104) received no text messages. A knowledge questionnaire (9 questions) was administered pre intervention. The same questionnaire was used with added health-related behaviour questions for the intervention group at exit. An intention-to-treat analysis was done. To compare the control and intervention group¿s knowledge, chi-squared tests/Fisher¿s exact tests and t-tests/Wilcoxon rank sum tests were carried out for binary and continuous outcomes, respectively. A focus group (n=7 from the intervention group) was conducted to explore experiences. Results show substantial loss to follow-up (only 57% of participants were retained at exit). No statistically significant difference was detected between the control and intervention group in any of the nine knowledge questions at exit (all p > 0.05). Focus group responses indicated that the text messages acted as a welcome reminder, a motivation for positive change, and as extended care from the health care provider. Conclusion suggest that while the intervention failed to improve antenatal health knowledge, evidence from self-reported behaviour and the focus group suggests that text messages have the potential to motivate change of health-seeking behaviour. Loss to follow-up is an important consideration for mobile health interventions in developing country settings.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 16/07/2012
Actual trial start date 16/07/2012
Anticipated date of last follow up 12/02/2012
Actual Last follow-up date 12/02/2013
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 206
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Not applicable Not applicable
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 Assigned to experiment or control groups alternating in order of recruitment The PI (Marion Heap) allocated participants to the intervention and control arms alternatively. Thus, the allocation sequence was not concealed to the person doing the allocation. However, only the PI was aware of the sequence, and the assessor of the outcomes was not. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Non-randomised Assigned to experiment or control groups alternating in order of recruitment The PI (Marion Heap) allocated participants to the intervention and control arms alternatively. Thus, the allocation sequence was not concealed to the person doing the allocation. However, only the PI was aware of the sequence, and the assessor of the outcomes was not. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Non-randomised Assigned to experiment or control groups alternating in order of recruitment The PI (Marion Heap) allocated participants to the intervention and control arms alternatively. Thus, the allocation sequence was not concealed to the person doing the allocation. However, only the PI was aware of the sequence, and the assessor of the outcomes was not. Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ante-natal health promotion disseminated by mobile phone The frequency of the dissemination of the SMSes, by days of the week varied according to the number of weeks pregnant at recruitment From recruitment at the first or ante-natal booking visit until the 38th week of pregnancy There were 39 SMS campaigns, one for each language group (Xhosa, Afrikaans English), by week of pregnancy at recruitment. Content of the SMSes was similar and designed to be appropriate to each trimester. The first and second trimesters focused on healthy living, attending clinic, understanding tests, monitoring baby-movements. The third trimester focused on labour, birth and mothering. 102
Control Group Ante-natal health promotion disseminated by mobile phone Standard of antenatal care From recruitment at the first or ante-natal booking visit until the 38th week of pregnancy Standard of antenatal care 104 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study recruited Pregnant women at first ante-natal booking visit, who were => 18 years of age <20 weeks pregnant The following groups were excluded. Women who were < 18 years of age at booking visit Women who were > 20 weeks pregnant at first booking Women who did not have a cellphone number 18 Year(s) 45 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 12/04/2011 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Drive Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge levels about pregnancy - Prior to the start of the campaign (at recruitment) - End of SMS campaign
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mitchells Plain Midwife Obstetric Unit First Avenue, Eastridge, Mitchell's Plain Cape Town 7789 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation (NRF) Meiring Naudé Road Pretoria 0184 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Health Science Faculty University of Cape Town Anzio Road Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Hanne Jensen Haricharan Anzio Road Cape Town 7925 South Africa
Leslie London Anzio Road Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marion Heap marion.heap@uct.ac.za 021 406 6978 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Marion Heap marion.heap@uct.ac.za 021 406 6978 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Researcher
Role Name Email Phone Street address
Scientific Enquiries Marion Heap marion.heap@uct.ac.za 021 406 6978 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Researcher
REPORTING
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