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

Pregnancy Clinical Trial

— CITRUPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801695
• Other study ID #: RC15_0475
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 20, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pregnancy

Intervention

Drug:
• Citrulline
Citrulline supplementation
• Placebo
Placebo

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes
France	Hôpital Cochin (Maternité Port-Royal)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days between the therapeutic initiation and childbirth		childbirth