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.: PACTR201210000424220 Date of Approval: 02/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using Mobile Phones to Promote Utilisation of Reproductive Healthcare Services, The Lagdo mHealth Pilot Study
Official scientific title Using Mobile Phones to Promote Utilisation of Reproductive Healthcare Services, The Lagdo mHealth Pilot Study
Brief summary describing the background and objectives of the trial There is a high utilisation rate of mobile phones in Africa. This opportunity can be used reduce the high maternal and child mortality rates in Cameroon. This study seeks to investigate the efficacy of mobile phones in increasing ante natal care service utilisation and reducing delays of pregnant women in distress in acessing emergency obstetrics care services.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Lagdo mHealth
Disease(s) or condition(s) being studied Maternal and Child healthcare,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 02/11/2012
Actual trial start date 05/10/2012
Anticipated date of last follow up 18/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 430
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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using computers on www.randomizer.org Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group use of mobile phone technologies (calls, voicemails and SMS) Participants in the intervention arm will be exposed to mHealth; they will be able to use their mobile phones to communicate with health care workers when they need help. 215
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women aged 16 years and above, at all stages of pregnancy, Pregnant women who either own a mobile phone or have a family member who owns a mobile phone, Pregnant women attending Hopital De District de Lagdo ante-natal clinic. Participants who are less than 16 years of age Participants declining consent. 16 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 04/10/2012 National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Bastos Yaounde Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ante Natal Clinic attendance rate Time of registeration First trimester of pregnancy Second trimester of pregnancy Third trimester of pregnancy Time of delivery
Primary Outcome Time to see a skilled birth attendant Whenever pregnant woman needs emergency obstetric care Time of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hopital de District de Lagdo Rue de Commune Lagdo 42 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
UNFPA Cameroon Bastos Yaounde Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNFPA Cameroon Bastos Yaounde Cameroon Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Okwen Patrick Mbah Omnisport Yaounde Cameroon
Irenee Domkam Omnisport Yaounde Cameroon
Rigobert Pambe Miong Omnisport Yaounde Cameroon
Patrick Mbah Okwen ADRA, Omnisport Yaounde Cameroon
Irenee Domkam ADRA, Omnisport Yaounde Cameroon
Pierre Celestin Mutarambirwa ADRA, Omnisport Yaounde Cameroon
Sharif Egal UNFPA, Bastos Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mbah Patrick Okwen okwenpatrick@yahoo.fr +23797118090 Omnisport
City Postal code Country Position/Affiliation
Yaounde Cameroon Health Expert
Role Name Email Phone Street address
Principal Investigator Mbah Patrick Okwen okwenpatrick@yahoo.fr +237 97118090 ADRA, Omnisport
City Postal code Country Position/Affiliation
Yaounde Cameroon Adventist Development and Relief Agency
Role Name Email Phone Street address
Public Enquiries Pierre Celestin Mutarambirwa adra_cameroon@yahoo.fr +237 74717815 ADRA, Omnisport
City Postal code Country Position/Affiliation
Yaounde Cameroon Country Director / Adventist Development and Relief Agency
Role Name Email Phone Street address
Public Enquiries Mbah Patrick Okwen okwenpatrick@yahoo.fr +23797118090 Omnisport
City Postal code Country Position/Affiliation
Yaounde Cameroon Health Expert
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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