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.: PACTR201306000550192 Date of Approval: 13/05/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation of evidence-based antenatal care in Mozambique: A cluster randomized controlled trial
Official scientific title Implementation of evidence-based antenatal care in Mozambique: A cluster randomized controlled trial
Brief summary describing the background and objectives of the trial Antenatal care represents in poor settings a unique opportunity for reaching women with a number of vital interventions. Health policies for ANC packages integrated with key interventions for HIV, malaria, anaemia, and syphilis find often bottlenecks and health system constraints limiting results. This study addresses these constraints through carrying out a demonstration project in 10 facilities in Mozambique to increase the delivery of evidence-based practices in an ANC integrated package.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ANC Mozambique
Disease(s) or condition(s) being studied Anaemia, syphilis,Haematological Disorders,Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Malaria
Purpose of the trial Prevention
Anticipated trial start date 15/07/2013
Actual trial start date 02/02/2014
Anticipated date of last follow up 16/03/2015
Actual Last follow-up date 30/01/2016
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
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
Randomised Computer-generated Stepped wedge design cluster randomization for 10 clusters Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ANC integrated package through kits Not applicable Not applicable Provision of kits to the facilities that would include the products required for the ANC consultations according to the current protocols and norms legislated by the Ministry of Health 40000 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women arriving for antenatal care in the 10 selected facilities No exclusion criteria 0 Year(s) 100 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 13/10/2010 WHO Research Ethics Review Committee (WHO ERC)
Ethics Committee Address
Street address City Postal code Country
Avenue Appia 20 Geneva 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Frequency of women receiving screening for syphilis at least once during pregnancy During pregnancy
Primary Outcome Frequency of women receiving screening for HIV in first ANC visit During pregnancy
Primary Outcome Frequency of women receiving screening for hypertension During pregnancy
Primary Outcome Frequency of women receiving intermittent preventive malaria treatment (1, 2 doses) During pregnancy
Primary Outcome Frequency of women receiving screening for anaemia During pregnancy
Primary Outcome Frequency of women receiving tetanus toxoid During pregnancy
Primary Outcome Frequency of women receiving iron supplementation During pregnancy
Primary Outcome Frequency of women receiving anti-parasitic treatment for anaemia prevention During pregnancy
Primary Outcome Frequency of sero-positive women receiving the administration of syphilis treatment (1,2 or 3 doses) During pregnancy
Primary Outcome Frequency of sero-positive women receiving administration of antiretroviral treatment (regimen and duration) During pregnancy
Secondary Outcome Frequency of midwives¿ positives attitudes and readiness to provide the selected practices To be determined
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CS Anexo Hospital Rural de Songo Tete Mozambique
CS Anexo Hospital Rural de Dondo Sofala Mozambique
CS da Matola Maputo province Mozambique
CS 25 de Setembro Nampula City Mozambique
CS Anexo Hospital Rural de Chokwe Gaza region Mozambique
CS 1ro de Maio Maputo Mozambique
CS Anexo Hospital Rural de Chibuto Gaza region Mozambique
CS de Anchilo Nampula District Mozambique
CS N° 2 Tete City Tete Mozambique
CS Anexo Hospital Rural de Montepuez Cabo Delgado region Mozambique
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization, Department of Reproductive Health and Research Avenue Appia 20 Geneva 1211 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organization, Department of Reproductive Health and Research Avenue Appia 20 Geneva 1211 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
International Center for Reproductive Health (ICRH) Rua Jose Macamo, 269 Maputo Mozambique
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ana Pilar Betrán betrana@who.int +41 22 791 4205 Avenue Appia 20
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Medical Officer, Department of Reproductive Health and Research, World Health Organization
Role Name Email Phone Street address
Public Enquiries Ana Pilar Betrán betrana@who.int +41 22 791 4205 Avenue Appia 20
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Medical Officer, Department of Reproductive Health and Research, World Health Organization
Role Name Email Phone Street address
Scientific Enquiries Ana Pilar Betrán betrana@who.int +41 22 791 4205 Avenue Appia 20
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Medical Officer, Department of Reproductive Health and Research, World Health Organization
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