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.: PACTR201512001090731 Date of Approval: 30/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the effects of clinical decision making support systems on maternal and neonatal mortality and morbidity using SMS messaging
Official scientific title EVALUATING THE EFFECTS OF CLINICAL DECISION MAKING SUPPORT SYSTEMS ON MATERNAL AND NEONATAL MORTALITY AND MORBIDITY IN GHANA: A CLUSTER RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana. Studies have identified poor quality of maternal and child healthcare as a major challenge to the prevention of neonatal and maternal deaths. Effective interventions are required to make significant inroads in these areas. Objective To evaluate the effect of a SMS text messaging intervention to support clinical decision making by frontline health care professionals on neonatal and maternal mortality. Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana, involving 8 intervention and 8 control districts. The intervention consists of text messaging of standard protocols for maternal and neonatal care to front line health care providers in the region. A total of 17,040 pregnant women who are receiving care (including antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the region will be monitored through monthly aggregate data on outcome measures such as neonatal and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this study. A quality of care assessment in four sampled districts to measure adherence to the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to explore baseline characteristics of study groups while logistic regression will be applied to evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05 will be used. Expected outcome We hypothesize that the intervention will improve both maternal and neonatal service delivery and health outcomes in intervention areas.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ACCELERATE
Disease(s) or condition(s) being studied Maternal and neonatal morbidity and mortality,Neonatal Diseases,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 18/05/2015
Actual trial start date 10/08/2015
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date 07/04/2017
Anticipated target sample size (number of participants) 17040
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT02468310 ClinicalTrials.gov
GHS-ERC: 10/09/14 Ghana Health Service Ethical Review Committee
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 blocks. Block size was 3 and block size varied. Central allocation by the use of a computer program to randomize districts into control and intervention districts Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Protocols for Maternal and Neonatal emergencies N/A 18 months Support system via SMS text messaging 8520 Uncontrolled
Control Group N/A N/A 18 months N/A 8520 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. District location in the Eastern region. 2. The districts should have an expected deliveries of 1,100 / year or more 3. The District Health Management Team and the District Hospital Management Team must agree to participate in the study. 1. District not located in the Eastern region. 2. The districts having an expected deliveries of < 1,100 / year 3. The District Health Management Team and the District Hospital Management Team disagree to participating in the study. 0 Day(s) 49 Year(s) Both
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 28/01/2015 Ghana Health Service Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Accra MB 190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neonatal mortality Total number of neonatal deaths among total number of deliveries over an 18 month period
Secondary Outcome Number of maternal deaths Total number of maternal deaths among total antenatal attendants over an 18 month period
Secondary Outcome Number of cases of eclampsia Total number of cases of eclampsia among total antenatal attendants over an 18 month period
Secondary Outcome Number of cases of postpartum haemorrhage Total number of cases of postpartum haemorrhage among total antenatal attendants over an 18 month period
Secondary Outcome Number of cases of prolonged labour Total number of cases of prolonged labour among total antenatal attendants over an 18 month period
Secondary Outcome Number of cases of puerperal sepsis Total number of cases of puerperal sepsis among total antenatal attendants over an 18 month period
Secondary Outcome Number of cases of birth asphyxia among deliveries Total number of cases of birth asphyxia among total deliveries over an 18 month period
Secondary Outcome Number of cases of low birth weight deliveries Total number of cases of low birth deliveries among total deliveries over an 18 month period
Secondary Outcome Number of cases of cord sepsis Total number of cases of cord sepsis among total deliveries over an 18 month period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kwahu South district Mpreso-Atibea MP 243 Ghana
Kwahu West district Nkwakaw 419 Ghana
West Akim district Asamankese 120 Ghana
Suhum district Suhum SU 122 Ghana
Nsawam-Adoagyiri district Nsawam 204 Ghana
Afram Plains Kwahu North district Donkorkrom 94 Ghana
Atiwaa district Kwabeng 44 Ghana
Asuogyaman district Akosombo 1 Ghana
Akwapim North district Mampong 107 Ghana
Birim Central district Akim Oda 429 Ghana
Birim North district New Abiriem 15 Ghana
Denkyembour district Akwatia KI 141 Ghana
East Akim district Kibi KY 12 Ghana
Fanteakwa district Begoro 60 Ghana
Kwaebibirem district Kade 114 Ghana
Lower Manya-Krobo district Krobo-Odumase 64 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Julius Center, University of Utrecht Stratenum 6.131 Utercht 3508 GA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Julius Center, University of Utrecht Stratenum 6.131 Utercht 3508 GA Netherlands University
COLLABORATORS
Name Street address City Postal code Country
Ghana Health Service Accra MB 190 Ghana
School of Public Health, University of Ghana Accra LG 13 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Irene Akua Agyepong iagyepong@hotmail.com +233 244 862 665 Stratenum 6.131
City Postal code Country Position/Affiliation
Utercht 3508 GA Netherlands University of Utercht
Role Name Email Phone Street address
Public Enquiries Hannah Brown Amoakoh ansomaame@hotmail.com +233 264 545 762 Noguchi Street
City Postal code Country Position/Affiliation
Accra LG 13 Ghana Clinical trials coordinator/University of Ghana/Accelerate Project
Role Name Email Phone Street address
Scientific Enquiries Evelyn Ansah ansahekdr@yahoo.co.uk +233 206 301 662 Castle road
City Postal code Country Position/Affiliation
Accra MB 190 Ghana Ghana Health Service Research and Development Division
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information