Antenatal Care Clinical Trial
— AIFASMaPOfficial title:
Strategies to Increase Antenatal Iron and Folic Acid Supplementation and Malaria Prophylaxis in Rural South-central Côte d'Ivoire: Study Protocol of a Cluster Randomised Controlled Trial
Verified date | February 2020 |
Source | Centre Suisse de Recherches Scientifiques en Cote d'Ivoire |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pregnancy increases the risk of malaria and nutritional deficiency. Despite some progress in ANC access over the past years, coverage of antenatal iron and folic acid supplementation (AIFAS) and intermittent preventive treatment of malaria in pregnancy (IPTp) remains low in many countries. The main objective of this research project is to identify the most effective ways to increase AIFAS and IPTp in low-income settings. We will assess the relative effectiveness of two strategies: the provision of information on the importance of AIFAS and IPTp for pregnant women (Intervention Arm I - demand side intervention), and the direct delivering of supplements and malaria drugs to women's homes (Intervention Arm 2 - supply side intervention). The two strategies will be tested through a small-randomized experiment with 720 pregnant women in the Taabo Health and Demographic Surveillance Site located in South-central Côte d'Ivoire. The primary outcome variable for the pilot study will be post-partum anemia and malaria infections. Secondary outcomes will be AIFAS and IPTp coverage as well as miscarriages, stillbirths and low birth weight deliveries as adverse birth outcomes.
Status | Not yet recruiting |
Enrollment | 720 |
Est. completion date | December 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Pregnant women in the first trimester of their pregnancy, living in the HDSS with an age greater than or equal to 15 years. - Be registered as a member in the HDSS of Taabo - Willing to provide one drop of blood for hemoglobin assessment and the rapid diagnostic malaria test. - Written informed consent - Under 18 years with permission of legal representative Exclusion Criteria: - No written informed consent - Under 18 years pregnant women without permission of legal representative - Not registered as a member of the HDSS of Taabo |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Centre Suisse de Recherches Scientifiques en Cote d'Ivoire | Swiss Tropical & Public Health Institute |
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants with a concentration of hemoglobin less than 11g/dL after delivery | Hemoglobin levels obtained assessed using HEMOCUE devices | Each mother will be enrolled in the study for approximately six months from the end of the first trimester to the endline survey conducted shortly after delivery. We will assess hemoglobin levels within the first two weeks after delivery | |
Primary | Percentage of participants tested positive for malaria | Malaria infection will be tested using standard Rapid Diagnostic Tests (RDTs). | Each mother will be enrolled in the study for approximately six months from the end of the first trimester to the endline survey conducted shortly after delivery. We will assess malaria infection within the first two weeks after delivery |
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