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

Phase 2

Completed

• Conditions: Pregnancy; Pre-eclampsia
• Interventions: Drug: Citrulline; Drug: Placebo

• Registration Number: NCT02801695
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Study Start: 2017-02-20
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Citrulline	Citrulline	Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery
Lactose	Placebo	Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery

Primary Outcome Measures

Name	Time	Method
number of days between the therapeutic initiation and childbirth	childbirth

Trial Locations

Locations (2)

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital Cochin (Maternité Port-Royal); 🇫🇷 Paris, France