Ultrasound Study in Pregnant Women With Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00840502
• Date of registration: 09/02/2009
• Primary sponsor: University of Oxford
• Public title: Ultrasound Study in Pregnant Women With Malaria UPS
• Scientific title: Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth
• Date of first enrolment: February 2009
• Target sample size: 400
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00840502
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

Thailand

Contacts

• Name: Francois Nosten, MD

• Name: Marcus Rijken, MD

• Name: Francois Nosten, MD
• Affiliation: Shoklo Malaria Research Unit

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria

Pregnant Women

Primary Outcome(s)

Ultrasound measurements [Time Frame: Up to birth]

Secondary Outcome(s)

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

Secondary ID(s)

SMRU0801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors