Ultrasound Study in Pregnant Women With Malaria (UPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00840502
First received: February 9, 2009
Last updated: August 27, 2013
Last verified: August 2013
  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 ] [ 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: December 2014
Estimated Primary Completion Date: December 2014 (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
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

No publications provided

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: August 27, 2013
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 August 21, 2014