NCT03174652: AnPREG

Anemia Pregnancy Outcome on the Thai-Myanmar Border

Completed Last updated 31 August 2018

What this trial tests

trial in Anemia Pregnancy in 13,520 participants. Completed in 20 July 2018.

Timeline

20 July 2017

Primary endpoint
20 July 2017

20 July 2018

Quick facts

Lead sponsor	University of Oxford
Status	Completed
Study type	OBSERVATIONAL
Enrollment	13,520
Start date	20 July 2017
Primary completion	20 July 2017
Estimated completion	20 July 2018
Sites	1 location across Thailand

Conditions studied

• Anemia Pregnancy — all drugs for Anemia Pregnancy →

Sponsor

University of Oxford

Who can join

Eligibility, female only, with Anemia Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The global burden of maternal morbidity and mortality attributable to anemia is staggering, and this is especially true in low-resource settings. A recent review suggests 42% of pregnant women have anemia worldwide (1993-2005) with the vast majority of anemic women (90%) residing in Africa or Asia1; and in Asia, anemia was the second highest cause of maternal mortality2. Anemia was diagnosed in almost one third to one half of women presenting to the Shoklo Malaria Research Unit (SMRU) clinics on the Thai-Myanmar border for antenatal care (ANC) in a 2008 survey3, and anemia at first antenatal visit was associated with a two-fold increase in maternal mortality in this population4. Studies have also shown an association between anemia and small for gestational age infants, preterm delivery, infant and childhood anemia and developmental delays5.

The anemia in pregnant women presenting to SMRU clinics is multifactorial, as hemoglobinopathies, Glucose-6-dehydrogenase (G6PD) deficiency, iron, folic acid and B12 deficiency, helminth infection, and malaria are all prevalent in this rural population. Though all of these pathologies can cause anemia, they require different and sometimes conflicting treatment and prevention strategies, interacting in a complex web of causes and effects. Iron supplementation is the mainstay of most anemia control programs, but some women with hemoglobinopathies suffer from potentially fatal iron overload6. Iron supplementation has also been associated with increased risk of malaria7. Some helminth infections are associated with increased rates of anemia and malaria, but others may be protective8. Malaria and G6PD deficiency have complex effects on one another, and some malaria treatments can cause acute and life-threatening hemolysis in G6PD deficient individuals9.

Given the high prevalence and diverse causes of anemia in this population, and its potentially dire effects on maternal and infant health and survival, SMRU implemented increased clinical testing for pregnant women in 2012 to inform clinical care at the individual level. Further analysis of these data is urgently needed to improve care on a population scale. We propose to review existing data from ANC records to determine the causes and effects of anemia in this population, and use this information to improve treatment and prevention guidelines. Results would be integrated rapidly into local practice with the potential to have profound impacts on maternal and child health in this region.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.