Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide
Status:
Completed
Trial end date:
2019-05-06
Target enrollment:
Participant gender:
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.