Clinical Trial: Trial of the Impact of Vitamin A on Maternal Mortality
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Brief Summary:
Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality.
Hypotheses:
- Weekly supplementation with vitamin A (7000 µg retinol equivalent [RE]) to reproductive age women will reduce maternal deaths by 33%.
- This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
- There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.
Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.
Detailed Summary:
Pregnancy accounts for nearly 600,000 deaths of women each year; maternal health problems are the largest contributors to the disease burden of adult women. Conventional primary health care approaches, which included Traditional Birth Attendant training and antenatal screening, had little impact on the maternal mortality ratio. Instead, the Safe Motherhood paradigm now aims to ensure emergency obstetric care (EMOC) at the district hospital level for the 10-15% of women who develop potentially life threatening complications, and is moving towards recommending that professionals attend all deliveries.
While the latter configurations of care have been shown to reduce maternal mortality, they require considerable political will, attention to health systems, and expansion of access to supervised delivery and EMOC. For the poorest countries, such capacity is some years down the line. Low-tech interventions which effectively reduce maternal mortality, and which can be delivered at the community level would be a welcome addition to the armamentarium of public health measures for preventing maternal mortality. Should vitamin A supplementation prove to be effective in reducing maternal mortality, or indeed all-cause female mortality, it would provide such a tool. Moreover, as there is considerable policy and programmatic interest in VAS for children, it is likely that such interest can be broadened to encompass supplementation for women. Furthermore, it is increasingly recognised that poverty not only increases the risk of ill health, but that ill health in turn plays a major role in creating and perpetuating poverty. A community-based intervention such as Vitamin A is likely to address the needs of the very poorest women, as these are the individuals least likely to have access to emergency obstetric care and professional birth attendants.
Original Secondary Outcome: i) Hospital admissions (ii) Occurrence of bleeding during pregnancy & spontaneous abortion iii) Maternal morbidity
Information By: London School of Hygiene and Tropical Medicine
Dates:
Date Received: September 13, 2005
Date Started: December 2000
Date Completion:
Last Updated: February 17, 2010
Last Verified: February 2010
