Overview

This trial is active, not recruiting.

Conditions termination of pregnancy, feticide
Treatment ultiva ® associated with a lethal reference agent, xylocaine ® in procedure of foeticide
Phase phase 3
Sponsor University Hospital, Montpellier
Start date October 2015
End date October 2017
Trial size 66 participants
Trial identifier NCT02597699, 2015-002856-28, 94602

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Arm
(Active Comparator)
reference protocol : Sufentanil ® associated with Xylocaine ® in Procedure of foeticide
ultiva ® associated with a lethal reference agent, xylocaine ® in procedure of foeticide Procedure of foeticide
Arm 2: Ultiva ® associated with a lethal reference agent, Xylocaine ® in Procedure of foeticide Arm 1 :Sufentanil ® associated with Xylocaine ® in Procedure of foeticide
(Experimental)
experimental protocol : Ultiva ® associated wih a lethal reference agent, Xylocaine ® in Procedure of foeticide
ultiva ® associated with a lethal reference agent, xylocaine ® in procedure of foeticide Procedure of foeticide
Arm 2: Ultiva ® associated with a lethal reference agent, Xylocaine ® in Procedure of foeticide Arm 1 :Sufentanil ® associated with Xylocaine ® in Procedure of foeticide

Primary Outcomes

Measure
The deadline of obtaining the asystole
time frame: up to 5 minutes

Secondary Outcomes

Measure
The success rate of the procedure of foeticide
time frame: within 2 minutes and persistent during at least 1 minute
The number of punction(s) of the cordon
time frame: 1 day
Number of side effects
time frame: 1 day
The quality of tissues (the fetopathologic analysis)
time frame: 1 day

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Age > = 18 years 2. 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 3. Patient member or beneficiary of a national insurance scheme 4. Patient capable of understanding the nature, the purpose and the methodology of the trial 5. Patient having given an informed consent signed before the inclusion in the trial Exclusion Criteria: 1. 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) 2. Major Patient protected by the law (guardianship, curators, or under protection of justice) 3. Patient deprived of freedom by court or administrative order

Additional Information

Official title Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide: A Phase III Randomized Trial
Principal investigator Romy RR RAYSSIGUIER, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.