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.: PACTR201610001685390 Date of Registration: 17/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Strategies for increasing Focused Antenatal Care clinic visits in the first trimester among pregnant women in Mangochi District, Malawi
Official scientific title Strategies for increasing Focused Antenatal Care clinic visits in the first trimester among pregnant women in Mangochi District, Malawi
Brief summary describing the background and objectives of the trial orld Health Organization (WHO) guidelines on Focused Antenatal Care (FANC) advocates for all pregnant women to be attending four targeted clinic visits with the first visit being done in the first trimester of pregnancy [1]. Coverage of FANC clinics visits in the first trimester by pregnant women is low (6-10%) in Mangochi district than the national coverage of 12% [2]. The study therefore intends to find out strategies that can assist to increase the percentage of FANC clinic visits in the first trimester by pregnant women in Mangochi district, Malawi. The hypothesis of the study is that ineffective health communication and lack of pregnancy rapid test kits in health centres are causing low coverage of FANC clinic attendance in the first trimester. The study intends to test the two strategies to find out if they will significantly increase FANC clinic visits by pregnant women in the district. The following are the study objectives: Broad Objective The overall objective of this study is to assess strategies that can assist to increase Focused Antenatal Care clinic attendance in first trimester for pregnant women in Mangochi District, Malawi. Specific Objectives 1. To evaluate the effect of implementing different strategies (health communication and diagnostic tests) on FANC clinic attendances in health facilities in Mangochi District (primary outcome objective). 2. To determine the prevalence of pregnancy outcomes of eclampsia between FANC first trimester attendees and those who do not start FANC services in the first trimester of pregnancy 3. To identify factors (drivers) that influence first trimester FANC attendance by pregnant women in the district
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Focused Antenatal Clinic Attendance in the first trimester,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 20845
Actual target sample size (number of participants) 20845
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.06/15/1742 College of Medicine Research and Ethics Committee (COMREC)_University of Malawi
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as Population size, Health Centre ownership, and participation in Performance Based Incentives Program were used Allocation determined by the holder of the sequence sho is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health Communication (Community Driven Total FANC Attendance) 1 year 12 months Arm 2: Health Communication (Community Driven Total FANC Attendance) In this arm, the main intervention will be the implementation of a health communication approach called Community Driven Total FANC Attendance (CDTFA). Identification of pregnant mothers in the first trimester will still be done by physical diagnosis as in arm 1 above. The new health communication approach will be implemented in 6828
Control Group No Intervention (Status Quo) 1 year 12 months No intervention (status Quo) 6500 Dose Comparison
Experimental Group Health Communication (Community Driven Total FANC Attendance) 1 year 12 months Arm 2: Health Communication (Community Driven Total FANC Attendance) In this arm, the main intervention will be the implementation of a health communication approach called Community Driven Total FANC Attendance (CDTFA). Identification of pregnant mothers in the first trimester will still be done by physical diagnosis as in arm 1 above. The new health communication approach will be implemented in 6600 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The population to be studied will include: 1. reproductive age group (15-49) comprising of all women who attended antenatal care in the previous year of the study. 2. women who will deliver live births during the period of the study, pregnant women who will attend antenatal care during the period of the study 3. spouses to women who attended antenatal care in the previous year of the study 4. village heads. 1. Women below 15 years of age and those above 49 years 2. Incompetent Persons 15 Year(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 College of Medicine Research and Ethics Committee (COMREC)_University of Malawi
Ethics Committee Address
Street address City Postal code Country
P/Bag 680 Blantyre Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women attanding FANC Clinics in the first trimester amongst the three arms 1 Year
Secondary Outcome Percentage of women utilizing Pregnancy Rapid test in the first trimester 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mangochi P.O. Box 42 Mangochi Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
African Doctoral and Dissertation Fellowship (ADDRF) Kenya Nairobi Kenya
Icelandic International Development Agency(ICEIDA) Iceida Country Office, Malawi Lilongwe Malawi
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Icelandic Development Agency Lilongwe Lilongwe Malawi Funding Agency
Primary Sponsor Amref Health Africa Kenya Kenya Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Mangochi District Council Box 138 Mangochi Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kondwani Mamba ngangakulaiti@yahoo.com +265 995 650 623 Box 42, Mangochi District Health Office
City Postal code Country Position/Affiliation
Mangochi Malawi Principa Investigator
Role Name Email Phone Street address
Public Enquiries William Peno williampeno@yahoo.com.au +265999338473 Mangochi District Health Office. P.O.Box 42
City Postal code Country Position/Affiliation
Mangochi Malawi Malawi Ministry of Health
Role Name Email Phone Street address
Scientific Enquiries William Stones rws6@st-andrews.ac.uk +265 994286077 PO Box 360 Chichiri, Blantyre-3 Malawi
City Postal code Country Position/Affiliation
Blantyre Malawi University of St Andrews/ Malawi College of Medicine
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