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Ultrasound Study in Pregnant Women With Malaria (UPS)

This study is currently recruiting participants.
Verified February 2016 by University of Oxford
Sponsor:
ClinicalTrials.gov Identifier:
NCT00840502
First Posted: February 10, 2009
Last Update Posted: February 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Oxford
  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:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Ultrasound measurements [ Time Frame: Up to birth ]

Secondary Outcome Measures:
  • Examination of all newborns [ Time Frame: 6 months post natal ]

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

Information from the National Library of Medicine

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


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
First Submitted: February 9, 2009
First Posted: February 10, 2009
Last Update Posted: February 15, 2016
Last Verified: February 2016

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