citrulline supplementation to reduce adverse pregnancy outcomes
Phase 3
- Conditions
- Pregnancy and Childbirth
- Registration Number
- PACTR202303697293140
- Lead Sponsor
- The Liverpool School of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 2960
Inclusion Criteria
Pregnant women aged 16 to 40 years,
Gestation should be less than 24 weeks cornfirmed by ultrasound
The pregnancy should be viable singleton pregnancy
The woman should be a residents of the study area, willing to adhere to scheduled and unscheduledstudy visit procedures, and willing to deliver in a study clinic or hospital.
Exclusion Criteria
Multiple pregnancies
Pre-existing hypertension,
women with renal disease and/or diabetes, or severe anaemia (Hb < 5 g/dL)
HIV-positive women
Malformations or nonviable pregnancy observed on enrolment ultrasound
known allergy or contraindication to any of the study supplements
unable to give consent
Concurrent participation in any other clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ‘The primary outcome is ‘adverse pregnancy outcome’ defined as a composite of fetal loss (spontaneous abortion or stillbirth), singleton live births born SGA or with LBW, or preterm birth (PTB). ‘Small for gestational age’ will be defined using the INTERGROWTH population reference’s 10th percentile.
- Secondary Outcome Measures
Name Time Method