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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	17 October 2016
Main ID:	ISRCTN88917252
Date of registration:	20/08/2015
Prospective Registration:	No
Primary sponsor:	Department of Global and International Health
Public title:	The effect of an enhanced antenatal care package for the control of malaria and anaemia in pregnancy in Ghana
Scientific title:	A cluster randomised controlled trial of an Enhanced AnteNatal Care service package for the control of Malaria and Anaemia in Pregnancy
Date of first enrolment:	01/09/2012
Target sample size:	1663
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN88917252
Study type:	Interventional
Study design:	Interventional cluster randomised controlled trial (Other)
Phase:

Countries of recruitment
Ghana

Contacts

Name:	Gifty Antwi
Address:	Kwame Nkrumah University of Science and Technology Accra Road - Kumasi Ghana
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
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Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Pregnant woman visiting the antenatal clinic for the first time for the current pregnancy
2. Up to 32 weeks gestation at booking
3. Haermoglobin = 7g/dl at booking
4. Within the catchment area of the health facility
Exclusion criteria: 1. Pregnant woman with a history or presence of any systemic illness likely to interfere with interpretation of trial results e.g. HIV-AIDS, sickle cell disease, G-6PD deficiency
2. Pregnant woman with any significant illness at time of screening that required hospitalization (including severe anaemia)

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

1. Malaria 2. Anaemia
Pregnancy and Childbirth

Intervention(s)

Control: Women in the control group will be provided with the current antenatal care package which includes: The taking of medical and obstetric history; measuring blood pressure, weight, height and temperature; measurement of symphysio-fundal height and foetal viability; routine urine and stool examinations, blood grouping, sickling test, VDRL for syphilis and HIV testing; screening for malaria and anaemia at the first antenatal visit and at for anaemia at 36 weeks gestation; giving intermittent preventive treatment for malaria and tetanus toxoid injections; folic acid and iron supplementation, presumptive de-worming, education on insecticide treated net use, dietary advice and scheduling of next antenatal care visits.

Intervention: In addition to receiving the current antenatal care package, women in the intervention group will participate in their antenatal care through the use of the simple, easy to interpret, visually appealing point-of-care tests: the rapid diagnostic test (RDT) for malaria and the haemoglobin colour scale (HCS) for anaemia.
The antenatal care staff will conduct the tests with the pregnant women, who are allowed to see their results during their antenatal care sessions.

Primary Outcome(s)

1. Prevalence of malaria parasitaemia at 4-8 weeks after enrollment
2. Prevalence of anaemia 4-8 weeks after enrollment

Secondary Outcome(s)

1. Prevalence of malaria parasitaemia prior to delivery
2. Prevalence of anaemia prior to delivery
3. Prevalence of low birth weight
4. Prevalence of sub-optimal pregnancy outcomes (still births, abortions, miscarriages)
5. Level of pregnant women's knowledge about malaria and anaemia in pregnancy
6. Level of pregnant women's adherence to health advice
7. Feasibility and acceptability of the use of HCS and RDT during antenatal care

Secondary ID(s)

N/A

Source(s) of Monetary Support

Malaria Capacity Development Consortium, London School of Hygiene and Tropical Medicine (UK)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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