Pregnant WomenUPSNCT00840502
Ultrasound Study in Pregnant Women With Malaria
An observational study of Pregnant Women and Malaria, run by University of Oxford at 1 site in Thailand.
Trial summary
Most of the neonatal deaths that occur worldwide every year are associated with low birth weight (LBW), caused by intrauterine growth restriction (IUGR) and/or preterm delivery. Accurate assessment of fetal growth and gestational age for timely identification and management of growth restriction are therefore public… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Malaria
- How many people
- 1,887 participants
- Where
- 1 siteThailand
- Study dates
- 10 Feb 2009to Feb 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregant women who present at the SMRU ante natal clinics. The antenatal clinics (ANC) are based on the Thai-Burmese border, in a region where Karen people (a minority group in Burma) are the principal inhabitants.
Who may be able to join
- Singleton viable pregnancy. If not detected at enrolment, multiple pregnancies will be excluded from the analysis.
- Age ≥18 years old.
- Willing and able to participate and comply with the study protocol and attend the SMRU ANCs regularly.
- EGA between 9+0 and 13+6 weeks by Ultrasound (CRL)
- Able to communicate in Burmese, Karen or English language
- written informed consent to participate in trial and follow consultation
Who cannot join
- Evidence of major congenital abnormality in the present pregnancy (e.g. anencephaly, omphalocele, hydrocephalus).
- Known chronic maternal illness.
- Thai national whose primary language is Thai
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth
Most of the neonatal deaths that occur worldwide every year are associated with low birth weight (LBW), caused by intrauterine growth restriction (IUGR) and/or preterm delivery. Accurate assessment of fetal growth and gestational age for timely identification and management of growth restriction are therefore public health priorities, especially in developing countries where 98% of all neonatal deaths occur. Every year, more than 50 million women become pregnant in malaria endemic regions. Malaria infection at any time during pregnancy reduces birthweight. However, little is known about the relationship between the timing of infection during pregnancy and the extent of the impact on birth weight. The mechanisms by which malaria causes LBW also remain unclear. Reduced placental blood flow, placental changes, red blood cell changes, severe anaemia and pro-inflammatory cytokines have all been implicated.
In this proposed, longitudinal, observational, minimal risk study, which will take place in SMRU antenatal clinics on the Thai-Burmese border, the effect of malaria infection during pregnancy on fetal growth will be determined. Women will be screened before 13+6 weeks of gestation and followed with regular ultrasound examinations during pregnancy. When a woman has a malaria infection an extra ultrasound scan will be done to measure growth retardation or placental blood flow changes. Bloodsamples will be taken to detect changes in red blood cell properties and putative markers of malaria infection. For this study the maximum amount of blood taken during pregnancy is 13 cc in an uninfected woman. For each malaria episode an additional 7 cc blood will be taken. After delivery a placenta and a cord sample will be taken to detect placental changes. The investigators aim to recruit four hundred pregnant women over the course of two years. This study involves minimal risk to participants as ultrasound examination is part of routine antenatal care in many countries in the world.
- Conditions
- Pregnant Women, Malaria
- Keywords
- malaria, ultrasound, pregnancy, Pregnant women (infected with malaria and without)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women who present at the SMRU antenatal clinics on the Thai Burmese border. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound measurements
Measured: Up to birth
Secondary outcomes (1)
Examination of all newborns
Measured: 6 months post natal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study start10 Feb 2009
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies 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
- Prospective
- Enrolment
- 1,887 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Nosten, MD, Principal investigator, Shoklo Malaria Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840502
- Sponsor's protocol ID
- SMRU0801
- Acronym
- UPS
- Status last verified
- Sep 2020
- First submitted
- 9 Feb 2009
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hashmi A, Carrara VI, Nyein PB, Darakamon MC, Charunwatthana P, McGready R. The Healthy Baby Flipbook: piloting home-based counseling for refugee mothers to improve infant feeding and water, sanitation, and hygiene (WASH) practices. Glob Health Action. 2019;12(1):1560115. doi: 10.1080/16549716.2018.1560115.
PubMed 31154995
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth
- ClinicalTrials.gov ID
- NCT00840502
- Acronym / sponsor ID
- UPS / SMRU0801
- Conditions
- Pregnant Women, Malaria
- Keywords
- malaria, ultrasound, pregnancy, Pregnant women (infected with malaria and without)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,887 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 10 Feb 2009 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 10 Feb 2009 (estimated)
- 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.
Most of the neonatal deaths that occur worldwide every year are associated with low birth weight (LBW), caused by intrauterine growth restriction (IUGR) and/or preterm delivery. Accurate assessment of fetal growth and gestational age for timely identification and management of growth restriction are therefore public health priorities, especially in developing countries where 98% of all neonatal deaths occur. Every year, more than 50 million women become pregnant in malaria endemic regions. Malaria infection at any time during pregnancy reduces birthweight. However, little is known about the relationship between the timing of infection during pregnancy and the extent of the impact on birth weight. The mechanisms by which malaria causes LBW also remain unclear. Reduced placental blood flow, placental changes, red blood cell changes, severe anaemia and pro-inflammatory cytokines have all been implicated.
In this proposed, longitudinal, observational, minimal risk study, which will take place in SMRU antenatal clinics on the Thai-Burmese border, the effect of malaria infection during pregnancy on fetal growth will be determined. Women will be screened before 13+6 weeks of gestation and followed with regular ultrasound examinations during pregnancy. When a woman has a malaria infection an extra ultrasound scan will be done to measure growth retardation or placental blood flow changes. Bloodsamples will be taken to detect changes in red blood cell properties and putative markers of malaria infection. For this study the maximum amount of blood taken during pregnancy is 13 cc in an uninfected woman. For each malaria episode an additional 7 cc blood will be taken. After delivery a placenta and a cord sample will be taken to detect placental changes. The investigators aim to recruit four hundred pregnant women over the course of two years. This study involves minimal risk to participants as ultrasound examination is part of routine antenatal care in many countries in the world.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women who present at the SMRU antenatal clinics on the Thai Burmese border. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregant women who present at the SMRU ante natal clinics. The antenatal clinics (ANC) are based on the Thai-Burmese border, in a region where Karen people (a minority group in Burma) are the principal inhabitants.
Key inclusion criteria (6 listed)
- Singleton viable pregnancy. If not detected at enrolment, multiple pregnancies will be excluded from the analysis.
- Age ≥18 years old.
- Willing and able to participate and comply with the study protocol and attend the SMRU ANCs regularly.
- EGA between 9+0 and 13+6 weeks by Ultrasound (CRL)
- Able to communicate in Burmese, Karen or English language
Key exclusion criteria (3 listed)
- Evidence of major congenital abnormality in the present pregnancy (e.g. anencephaly, omphalocele, hydrocephalus).
- Known chronic maternal illness.
- Thai national whose primary language is Thai
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
Ultrasound measurements
Time frame: Up to birth
1 secondary outcome
Examination of all newborns
Time frame: 6 months post natal
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 2 Sep 2020.
- Derived from this study: PubMed 31154995Hashmi A, Carrara VI, Nyein PB, Darakamon MC, Charunwatthana P, McGready R. The Healthy Baby Flipbook: piloting home-based counseling for refugee mothers to improve infant feeding and water, sanitation, and hygiene (WASH) practices. Glob Health Action. 2019;12(1):1560115. doi: 10.1080/16549716.2018.1560115.
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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.
Francois Nosten, MD principal investigator
Shoklo Malaria Research Unit
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 Pregnant Women and Malaria, 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 6 inclusion and 3 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 2 Sep 2020. 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?
Ultrasound measurements (time frame: Up to birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00840502, which also lists 1 linked publication.
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 2 Sep 2020.