Pregnancy and Childbirth
Conditions
Interventions
Placebo
Lcitrulline powder
Sponsors
The Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ‘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
| Measure | Time frame |
|---|---|
| EFFICACY OUTCOME Peripheral arterial resistance and Systolic and diastolic blood pressure; gestational hypertension Malaria infection during pregnancy detected by microscopy and PCR Placental malaria detected by microscopy, by molecular methods, or by histology (past and active infection) Individual components of the placental malaria composite Uncomplicated clinical malaria during pregnancy Severity of maternal malaria infection SARS-CoV-2 infection severity during pregnancy Maternal anaemia and haemoglobin concentration during pregnancy and delivery Individual components of the adverse pregnancy outcome composite, and sub-composites including fetal loss (spontaneous abortions and stillbirth) and adverse livebirth (SGA-LBW-PTB composite) Fetal growth (estimated by validated ultrasound and maternal biomarkers2) Birthweight, gestational age, birthweight-for-gestational age Newborn anthropometric measures: head circumference, length, umbilical abdominal circumference, and mid-upper arm circumference Congenital anaemia Congenital malaria infection Congenital SARS-CoV-2 infection Neonatal death Composite of fetal loss and neonatal mortality Neonatal sepsis Early childhood neurocognitive development;SAFETY OUTCOMES Allergic reaction,anaphylaxis, hives/rash Maternal mortality Other SAEs and AEs Congenital abnormalities;TOLERANCE OUTCOMES Vomiting study supplement Gastrointestinal complaints including nausea, dyspepsia, diarrhoea Other symptoms including dizziness, syncope, palpitations;LABORATORY OUTCOMES concentration, asymmetric dimethylarginine (ADMA) concentration, L-arginine/ADMA ratio, and symmetric dimethylarginine (SDMA concentration) and Markers of L-arginine bioavailability and nitric oxide biogenesis including: plasma L-arginine Markers of endothelial function, placental function and inflammation including plasma concentrations of Angiopoietin (Ang)-1, Ang-2, soluble Tyrosine kinase with immunoglobulin-likLaboratoryand EGF-l | — |
Countries
Kenya
Contacts
Public ContactFeiko TerKuile
Chief Investigator
Outcome results
None listed