Ultrasound Study in Pregnant Women With Malaria (UPS)

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ClinicalTrials.gov Identifier: NCT00840502

Recruitment Status : Active, not recruiting

First Posted : February 10, 2009

Last Update Posted : October 2, 2018

Sponsor:

Information provided by (Responsible Party):

University of Oxford

Study Description

Brief 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 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.

Condition or disease
Pregnant Women Malaria

Study Design


Study Type :	Observational
Actual Enrollment :	1887 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth
Study Start Date :	February 2009
Estimated Primary Completion Date :	September 2019
Estimated Study Completion Date :	September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Ultrasound

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Pregnant women Pregnant women who present at the SMRU antenatal clinics on the Thai Burmese border.

Outcome Measures

Primary Outcome Measures :

Ultrasound measurements [ Time Frame: Up to birth ]

Secondary Outcome Measures :

Examination of all newborns [ Time Frame: 6 months post natal ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840502

Locations


Thailand
Shoklo Malaria Research Unit
Mae Sot, Tak, Thailand, 63110

Sponsors and Collaborators

University of Oxford

Investigators


Principal Investigator:	Francois Nosten, MD	Shoklo Malaria Research Unit

More Information


Responsible Party:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00840502 History of Changes
Other Study ID Numbers:	SMRU0801
First Posted:	February 10, 2009 Key Record Dates
Last Update Posted:	October 2, 2018
Last Verified:	October 2018

Keywords provided by University of Oxford:


malaria ultrasound pregnancy Pregnant women (infected with malaria and without)

Additional relevant MeSH terms:


Malaria Protozoan Infections Parasitic Diseases

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