Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)

Study Overview
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Brief Summary
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Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. The early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a disease that causes prematurity and currently the only known cure is delivery of the placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia is directly related to a failure of placental NO production. In this context, several clinical trials have tested the effect of NO donors such as L- arginine. However, supplementation with L -Arginine in a randomized trial in Nantes, has proved to be ineffective in severe vascular IUGR. Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, Citrulline may therefore be more effective in the treatment of pre-eclampsia. This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.

Official Title
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Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)

Conditions
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Pre-eclampsia, Pregnancy

Intervention / Treatment
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* Drug: Citrulline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >= 18 years old pregnant woman singleton pregnancy woman with pre-eclampsia (<36 weeks) without indication of forthcoming extraction subjects affiliated with an appropriate social security system subjects out of context of guardianship written signed informed consent form Exclusion Criteria: age < 18 years old isolated hypertension or isolated proteinuria severe pre-eclampsia with indication of forthcoming extraction in emergency term pregnancy >= 36 Weeks when diagnosis is done multiple pregnancy lactose intolerance context of guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-Citrulline<br>Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery | Drug: Citrulline<br>* Citrulline supplementation<br>|
| Placebo Comparator: Lactose<br>Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days between the therapeutic initiation and childbirth |  | childbirth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-eclampsia, citrulline, pregnancy