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New treatment option for Pregnancy
Official title L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
ClinicalTrials.gov ID: NCT05934318
What this study is testing
- What it's testing
- There are few safe, effective, and affordable interventions to improve pregnancy outcomes in low resource settings where the highest rates of poor birth outcomes occur. L-citrulline is naturally found in many foods and is changed into another important amino acid, L-arginine, in the body.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant women aged 16-40 years,
- inclusive to 24 weeks gestational age as confirmed by ultrasound,
- who have a viable singleton pregnancy,
- are residents of the study area,
- willing to adhere to scheduled and unscheduled study visit procedures,
You likely can't join if
- multiple pregnancies (i.e. twin/triplets);
- pre-existing hypertension, renal disease and/or diabetes, or severe anaemia (Hb \< 5 g/dL);
- HIV-positive or HIV status unknown;
- malformations or nonviable pregnancy observed on enrolment ultrasound;
- known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet;
- unable to give consent; or concurrent participation in any other clinical trial
See the full eligibility criteria
- Pregnant women aged 16-40 years,
- inclusive to 24 weeks gestational age as confirmed by ultrasound,
- who have a viable singleton pregnancy,
- are residents of the study area,
- willing to adhere to scheduled and unscheduled study visit procedures,
- willing to deliver in a study clinic or hospital
- multiple pregnancies (i.e. twin/triplets);
- pre-existing hypertension, renal disease and/or diabetes, or severe anaemia (Hb \< 5 g/dL);
- HIV-positive or HIV status unknown;
- malformations or nonviable pregnancy observed on enrolment ultrasound;
- known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet;
- unable to give consent; or concurrent participation in any other clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Kisumu, Kenya
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kisumu, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.