Anemia PregnancyAnPREGNCT03174652
Anemia Pregnancy Outcome on the Thai-Myanmar Border
An observational study of Anemia Pregnancy, run by University of Oxford at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia Pregnancy
- How many people
- 13,520 participants
- Where
- 1 siteThailand
- Study dates
- 20 Jul 2017to 20 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Data from approximately 15,548 new pregnant women enrolled to antenatal care from antenatal care (ANC) services of Shoklo Malaria Research Unit (SMRU) clinics during August 2012 to 31-Dec-2016.
Who may be able to join
- Pregnant woman voluntarily presented at SMRU antenatal clinics and at the first antenatal visit they were counselled about the types of tests that would be made available and that if they did not want to do them they could opt out and SMRU would still provide antenatal care, as for any other pregnant woman.
Who cannot join
- Women who chose to opt out of clinical sampling were excluded. Additionally, a very small number of women who were unstable at presentation to SMRU clinics were not sampled if sampling would have interfered with their clinical care.
- However, since samples were generally clinically indicated to guide care in these patients, the majority did have testing done.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Causes and Impact of Anemia on Pregnancy Outcome on the Thai-Myanmar Border: Retrospective Analysis
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.
- Conditions
- Anemia Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematology
The contribution of thalassemia/other inherited red blood cell (IRBC) abnormalities to anemia in pregnant refugee and migrant Myanmar women attending antenatal clinics in a low resource setting.
Measured: 1 year
Secondary outcomes (3)
Hematology
The interaction between thalassemia/ other IRBC abnormalities and environmental (nutritional and infectious) causes of anemia
Measured: 1 year
Serum ferritin
The pattern of iron stores (measured by serum ferritin) in pregnant women with thalassemia/ other IRBC abnormalities
Measured: 1 year
The risk of maternal morbidities
The risk of maternal morbidities (especially gestational diabetes, preeclampsia, miscarriage) and/or infant morbidities (small for gestational age, stillbirth, anemia, predisposition to infection in the first year of life) in pregnancies with maternal thalassemia/other IRBC abnormalities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start20 Jul 2017
- Primary completion20 Jul 2017
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia PregnancyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174652
- Sponsor's protocol ID
- SMRU1703
- Acronym
- AnPREG
- Status last verified
- Aug 2017
- First submitted
- 30 May 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Impact of Anemia on Pregnancy Outcome on the Thai-Myanmar Border: Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03174652
- Acronym / sponsor ID
- AnPREG / SMRU1703
- Conditions
- Anemia Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,520 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data from approximately 15,548 new pregnant women enrolled to antenatal care from antenatal care (ANC) services of Shoklo Malaria Research Unit (SMRU) clinics during August 2012 to 31-Dec-2016.
Key inclusion criteria (1 listed)
- Pregnant woman voluntarily presented at SMRU antenatal clinics and at the first antenatal visit they were counselled about the types of tests that would be made available and that if they did not want to do them they could opt out and SMRU would still provide antenatal care, as for any other pregnant woman.
Key exclusion criteria (2 listed)
- Women who chose to opt out of clinical sampling were excluded. Additionally, a very small number of women who were unstable at presentation to SMRU clinics were not sampled if sampling would have interfered with their clinical care.
- However, since samples were generally clinically indicated to guide care in these patients, the majority did have testing done.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hematology
Time frame: 1 year
The contribution of thalassemia/other inherited red blood cell (IRBC) abnormalities to anemia in pregnant refugee and migrant Myanmar women attending antenatal clinics in a low resource setting.
3 secondary outcomes
Hematology
Time frame: 1 year
Serum ferritin
Time frame: 1 year
The risk of maternal morbidities
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia Pregnancy, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematology (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.