Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide

NCT02597699 | Completed Phase 3

• 2 other identifiers: 946022015-002856-28
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The feticide is a legal and ethical obligation during a termination of pregnancy after 22 weeks' gestation. This method raise concerns about the fetal pain, maternal complications and the fetopathologic analysis. There are few studies on the subject. Investigators want to evaluate a drug in order to facilitate this method technically and emotionally challenging. They want to achieve a quick fetal asystole, a fetal analgesia, a maternal security and a optimal fetopathologic analysis. A drug, remifentanil Ultiva®, seems could meet its properties, it is a powerful morphine. A phase 2 clinical trial has assessed the feasibility, efficacy and safety of Ultiva®. They had not been able to prove bradycardia or lethal effect of Ultiva injected alone but the feasibility and safety were good. Investigators want to set up a randomized clinical trial with 2 arms : Ultiva® and lidocaine versus sufentanil and lidocaine (standard protocol), it is a bicentric study. The primary outcome is the interval between the vascular injection of lidocaine and fetal asystole. The secondary outcomes are the success rate of method, the number of puncture of the umbilical cord, the maternal side effects and the quality of fetopathologic analysis. The previous observational study showed a median interval of 2,3 minutes and a success rate of 55% (lower interval to 2 minutes). From the results they calculate a necessary inclusions to 66 patients. They believe that the bradycardia property of Ultiva® allow a potentiation of the efficacy of lidocaine. If the results are satisfactory, the use of Ultiva® can be generalized to other fetal medicine team.

Conditions

Termination of Pregnancy; Feticide

Keywords

Termination of pregnancy; Feticide; Fetal pain; Remifentanil Ultiva®; Fetal asystole; Fetopathologic analysis

Outcome Measures

Primary Outcomes (1)

• The deadline of obtaining the asystole

  The deadline of obtaining the asystole after the beginning of the injection of the ULTIVA associated with Xylocaine versus the reference protocol Sufentanil and Xylocaine

  up to 5 minutes

Secondary Outcomes (4)

• The success rate of the procedure of foeticide

  within 2 minutes after injection of Lidocaïne and persistent during at least 1 minute

• The number of new punction(s) of the cordon

  1 day

• Number of side effects

  1 day

• The quality of tissues (the fetopathologic analysis)

  1 day

Study Arms (2)

Arm 1: Sufentanil + Lidocaïne

ACTIVE COMPARATOR

For patients randomized to arm 1, as in the current practice, we will inject Sufentanil intra-cordially at the dose of 1.5 μg / kg of the estimated fetal weight, then the Lidocaïne 1% bolus of 10 ml (10 mg / ml). If 2 minutes after the start of the injection of Lidocaïne, there is no obtaining of fetal asystole, we will inject 100mg of Lidocaïne 1% in bolus of 10 ml. In the event of failure of the procedure, we will inject 10ml of KCL 10% intra-cordial if the cord is always accessible, if not intra-cardiac.

Drug: Sufentanil + Lidocaïne

Arm 2: Remifentanil + Lidocaïne

EXPERIMENTAL

For patients randomized to arm 2, we will inject 30 μg of intravenous Remifentanil (Ultiva®) followed by Xylocaine 1% in a 10 ml bolus (10 mg / ml). If 2 minutes after the start of the injection of Lidocaïne, there is no obtaining of asystole, we will inject 100 mg of Lidocaïne 1% in bolus of 10 ml. In case of failure of the procedure, we will inject 10 ml of KCL 10% intra-cordial if the cord is still accessible, if not intra-cardiac.

Drug: Remifentanil + Lidocaïne

Interventions

Remifentanil + Lidocaïne DRUG

Also known as: Ultiva® + Xylocaïne®

Arm 2: Remifentanil + Lidocaïne

Sufentanil + Lidocaïne DRUG

Also known as: Sufentanil + Xylocaïne®

Arm 1: Sufentanil + Lidocaïne

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> = 18 years
• Patient having received an authorization of medical termination of pregnancy beyond 22 weeks of amenorrhea by the Multidisciplinary Centers of Prenatal Diagnosis of Montpellier or Nimes
• Patient member or beneficiary of a national insurance scheme
• Patient capable of understanding the nature, the purpose and the methodology of the trial

You may not qualify if:

• Patient presenting a selective or total feticide in the cases of multiple pregnancies (the first preferential way in these cases is intracardiac, moreover the act risks to be complicated by the active movements of the other foetus)
• Major Patient protected by the law (guardianship, curators, or under protection of justice)
• Patient deprived of freedom by court or administrative order

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (2)

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Nîmes University Hospital

Nîmes, 30029, France

Location

Related Publications (1)

• Rayssiguier R, Fuchs F, Mousty E, Morau E, Hlioua T, Wells C, Musizzano Y, Nagot N, Graf C, Legoux C, Boulot P, Dumont C. Use of Remifentanil Associated with Lidocaine for Feticides in Late Terminations of Pregnancy: A Randomized Clinical Trial. Fetal Diagn Ther. 2021;48(11-12):812-818. doi: 10.1159/000520448. Epub 2021 Nov 22.

  PMID: 34808620 RESULT

MeSH Terms

Interventions

Remifentanil; Sufentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl

Study Officials

• Romy RR RAYSSIGUIER, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: November 5, 2015
• Study Start: December 18, 2015
• Primary Completion: March 7, 2019
• Study Completion: May 6, 2019
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (2)