Ultrasound Study in Pregnant Women With Malaria (UPS)

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2016 by University of Oxford

Sponsor:

Information provided by (Responsible Party):

University of Oxford

ClinicalTrials.gov Identifier:

NCT00840502

First received: February 9, 2009

Last updated: February 12, 2016

Last verified: February 2016

History of Changes

Purpose

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
Pregnant Women Malaria


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth

Resource links provided by NLM:

MedlinePlus related topics: Malaria Ultrasound

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:

Ultrasound measurements [ Time Frame: Up to birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Examination of all newborns [ Time Frame: 6 months post natal ] [ Designated as safety issue: No ]


Estimated Enrollment:	400
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
Pregnant women Pregnant women who present at the SMRU antenatal clinics on the Thai Burmese border.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840502

Contacts


Contact: Marcus Rijken, MD	66834102208	marcus@shoklo-unit.com
Contact: Phaikyeong Cheah, PhD		phaikyeong@tropmedres.ac

Locations


Thailand
Shoklo Malaria Research Unit	Recruiting
MaeSod, Tak, Thailand, 63110
Contact: Francois Nosten, MD francois@tropmedres.ac

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
Study First Received:	February 9, 2009
Last Updated:	February 12, 2016
Health Authority:	Thailand: Ministry of Public Health

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

ClinicalTrials.gov processed this record on September 27, 2016

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