Home
 


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: www.pactr.org

Trial no.: PACTR201306000550192 Date registered: 2013/05/13
TRIAL DESCRIPTION
Public title A demonstration project for the implementation of the WHO antenatal care model in Mozambique: A cluster randomized controlled trial.
Official scientific title A demonstration project for the implementation of the WHO antenatal care model 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 HIV/AIDS , Malaria ,
Purpose of the trial Prevention
Anticipated trial start date 2013-07-15
Actual trial start date
Anticipated date of last follow up 2015-03-16
Actual date of last follow up
Anticipated target sample size (number of participants) 10 clus   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
Single group: all participants receive same intervention throughout study 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 Min age Max age Gender
All women arriving for antenatal care in the 10 selected facilities No exclusion criteria 0 Year 100 Years 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 2010/10/13 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 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
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

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 Fax
Scientific Enquiries Dr Ana Pilar Betrán betrana@who.int +41 22 791 4205 +41 22 791 4171
Street address City Postal code Country Position / Affiliation
Avenue Appia 20 Geneva 1211 Switzerland Medical Officer, Department of Reproductive Health and Research, World Health Organization
Role Name Email Phone Fax
Principal Investigator Dr Ana Pilar Betrán betrana@who.int +41 22 791 4205 +41 22 791 4171
Street address City Postal code Country Position / Affiliation
Avenue Appia 20 Geneva 1211 Switzerland Medical Officer, Department of Reproductive Health and Research, World Health Organization
Role Name Email Phone Fax
Public Enquiries Dr Ana Pilar Betrán betrana@who.int +41 22 791 4205 +41 22 791 4171
Street address City Postal code Country Position / Affiliation
Avenue Appia 20 Geneva 1211 Switzerland Medical Officer, Department of Reproductive Health and Research, World Health Organization