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.: PACTR201410000889209 Date of Approval: 16/09/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Post delivery mobile health family planning
Official scientific title Effect of targeted multimodal mhealth messages on the uptake of modern contraceptive methods in the early postpartum period, a randomized control trial
Brief summary describing the background and objectives of the trial BACKGROUND Remote consultation using two way targeted health messages via mobile phone and popular social media platforms are a potential medium for augmenting uptake of modern contraception in the early postpartum period. Uptake of contraception in the early postpartum period provides health and social benefits. The increasing trend of mobile phone ownership, usage and extensive mobile network coverage provides an opportunity for its use in promoting contraceptive uptake and usage via remote consultation. OBJECTIVE This study is primarily designed to determine the impact of a targeted mhealth strategy on modern contraceptive uptake in the early postpartum period. The study targets a rise in the uptake from the current 50% uptake to the national 2015 target of 70% with this intervention. This study is secondarily designed to evaluate patient satisfaction with contraceptive services offered at our facility with and without the mhealth intervention and identify barriers to postpartum contraceptive uptake at our facility
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postpartum contraception,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2014
Actual trial start date
Anticipated date of last follow up 14/02/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 238
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 simple randomisation using a randomisation table created by a computer software program allocation will be 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
Control Group no intervention none 6weeks none 119
Experimental Group Contraception information 2nd to 6th weeks postpartum 6 weeks ¿ contraception info leaflet administered before discharge after deliver, follow-up contraception consult 6 wks review and exit postpartum clinic. 3 times wkly text or social media messages on mobile phones with opportunity to consult on any aspect of contraception (remote consult). Clients selct mode of message delivery. The messages will be sent 2nd to 6th wk postpartum 5am to 5pm. 119
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Immediate postpartum women following delivery ¿ Good maternal and neonatal outcome at delivery and discharge (no neonatal NICU, NHDU or maternal puerperal psychosis/ HDU admission) ¿ Own a functional mobile phone and active registered number; willing and able to use mobile text messaging or a social media platform ¿ Not already on or planning immediate postpartum contraceptive method (eg.IUD, BTL, vasectomy, IUS) ¿ Plan to attend the 6th week postpartum follow-up clinic at AKUHN. -not in the early postpartum period -poor maternal or neonatal outcomes -has received immediate post delivery contraception -no access to mobile phone 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
No 05/08/2014 agakhan university hospital
Ethics Committee Address
Street address City Postal code Country
3rd parklands avebue nairobi 30270-00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome modern contraceptive uptake in the early postpartum period. The study targets a rise in the uptake from the current 50% uptake to the national 2015 target of 70% with this intervention. 6weeks postdelivery after postnatal clinic visit
Secondary Outcome to evaluate patient satisfaction with contraceptive services offered at our facility with and without the mhealth intervention 6 weeks post delivery after postnatal clinic visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agakhan university hospital Nairobi 3rd parklands avenue nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
agakhan university hospital 3rd parklands avenue nairobi 30270-00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor agakhan university hospital 3rd parklands avenue nairobi 30270-00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
agakhan university hospital 3rd parklands avenue nairobi 30270-00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator robert ogutu robertogutu2014@gmail.com +254734864256 3rd parklands
City Postal code Country Position/Affiliation
nairobi 00100-6427 Kenya resident-obgyn
Role Name Email Phone Street address
Public Enquiries wangira musana wangira.musana@aku.edu +254 (0) 20 366 2000 3rd parklands
City Postal code Country Position/Affiliation
nairobi 30270-00100 Kenya consultant
Role Name Email Phone Street address
Scientific Enquiries mukaindo mwaniki mukaindo.mwaniki@aku.edu +254 (0) 20 366 2000 3rd parklands
City Postal code Country Position/Affiliation
nairobi 00100 Kenya consultant
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information