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.: PACTR202001700173081 Date of Approval: 14/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Electronic Mobile Phone Application Compared with Mother and Child Health Booklet in Improving Quality of Antenatal Care from First Visit through Third Trimester at Kenyatta National Hospital, A Randomized Controlled Trial
Official scientific title Efficacy of Electronic Mobile Phone Application Compared with Mother and Child Health Booklet in Improving Quality of Antenatal Care from First Visit through Third Trimester at Kenyatta National Hospital, A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality both directly, through detection and treatment of pregnancy related complications and indirectly through identification of women at increased risk of developing complications during labour and delivery. It also provides an opportunity to prevent and manage concurrent diseases such as HIV and Malaria, which as part of indirect causes of maternal morbidity and mortality, contribute to 25% of maternal deaths and near misses. Similar studies assessing mobile phone interventions to improve antenatal care services have been conducted in several countries in Africa. The PANDA (Pregnancy and Newborn Diagnostic Assessment) mHealth Pilot study in Madagascar, concluded that a mobile health system is usable and feasible to conduct complete and standardized ANC visits according to WHO guidelines, thus providing a promising solution to increase access to high quality and standardized ANC for pregnant women in remote areas. In this study, we will provide antenatal care with a mobile phone application that will be used by the clinician to collect data using an inbuilt checklist, flag abnormal results and send SMS reminders to the pregnant women prior to each visit. Objective: To determine the efficacy of using an electronic mobile phone application compared to the Mother and Child Health booklet in improving quality of antenatal care from first visit to third trimester in KNH Primary Objectives: Among antenatal patients at KNH who receive electronic mobile phone based care versus the Mother and Child Health booklet care from the first visit to third trimester of pregnancy: 1. To compare the proportion of complete antenatal care records and birth and emergency care plan 2. To compare the proportion of antenatal mothers with risk factors for adverse pregnancy outcomes identified 3. To compare the clinic attendance rates Secondary : To describe health worker experience using the mobile application
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Antenatal Care
Purpose of the trial Early detection /Screening
Anticipated trial start date 03/06/2019
Actual trial start date 03/06/2019
Anticipated date of last follow up 08/11/2019
Actual Last follow-up date 08/11/2019
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants) 100
Recruitment status Completed
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile phone application for antenatal care From first antenatal visit to 28 weeks In this study, we provided antenatal care with a mobile phone application that was used by the clinician to collect data using an inbuilt checklist. It also flagged abnormal results and sent SMS reminders to the pregnant women prior to each visit to improve clinic attendance rates. For the intervention group, there were four components of the electronic system; the mobile application, web application, external servers and main system server which was the KNH server. The mobile application was an android based application which is implemented using Native Java, XML and SQLite. The application was primarily used by the clinicians to collect data. The data sent from the application forms was sent using the RESTful APIs and Volley Libraries which was the integration between the main server and the android application. The application also enabled the clinicians to view simpler reports including the appointments, patient profiles, background information and all the services the patient had received since admission. The web application provided comprehensive reports about all the patients, the services they have been offered, the flagged metrics and clinical officers management module. It allowed data to be exported in pdf and excel formats. The external servers were used to send SMS to the expectant mothers and send mobile notifications to the antenatal clinicians. The main system server contained the main system and the database. This was hosted in the KNH servers to ensure security and confidentiality of the patient data. The connection between the web application and the main server was made using the HTTPS protocol to ensure end-to-end encryption of the data communication. The android application was using the Django Restful API to communicate to the server. 48
Control Group Mother and Child Health Booklet From first antenatal visit to 28 weeks The Mother and Child Health Booklet, distributed by the Ministry of Health in 2009 has been adopted in Kenyatta National Hospital and other antenatal care facilities. It provides visual reminders to the clinician and patients, in the form of advice on danger signs, and important information about pregnancy. It also contains checklists to enable the clinician to fill mandatory information. In so doing it has helped to standardize antenatal care across different facilities. 48 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women attending clinic for the first time in KNH 2. Pregnant women who were less than 28 weeks’ gestation 3. Women who provided informed consent to participate in the study 1. Pregnant women who had already attended antenatal care clinic in other facilities and had the Mother and Child Health Booklet 2. Women with lack of access to a mobile phone that could receive SMS reminders prior to clinic visits 3. Women with unconfirmed pregnancies by ultrasound or pregnancy diagnostic test Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 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 06/12/2018 Kenyatta National Hospital Univ Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Completeness of health records, development of birth and emergency plan, risk factor identification, clinic attendance rates 28 weeks gestation
Secondary Outcome Health worker experience in using the application 28 weeks gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital Road Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenyatta National Hospital Research and Programs Hospital Road Nairobi 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta National Hospital Research and Programs Hospital Road Nairobi 00202 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Alfred Osoti Hospital Road Nairobi Kenya
Dr. Rosa Chemwey Hospital Road Nairobi Kenya
Prof. Karanja Joseph G. Hospital Road Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sumayya Badamana sumayyabadamana@gmail.com +254727746693 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Postgraduate Student at University of Nairobi
Role Name Email Phone Street address
Public Enquiries Sumayya Badamana sumayyabadamana@gmail.com +254727746693 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Postgraduate Student at University of Nairobi
Role Name Email Phone Street address
Scientific Enquiries Alfred Osoti alfredosoti@icloud.com +254733886664 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Consultant Obstetrician Gynecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlies the results reported in this article after deidentification. Clinical Study Report,Informed Consent Form,Study Protocol Will be available within 12 months of completion of the study, for 2 years Open access to researchers for any purpose. Requests to be sent to sumayyabadamana@gmail.com. Criteria for reviewing requests will be qualifications and quality of requests.
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