Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02597699 |
| Other study ID # |
94602 |
| Secondary ID |
2015-002856-28 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 18, 2015 |
| Est. completion date |
May 6, 2019 |
Study information
| Verified date |
December 2020 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The intervention will take place, as in the framework of usual care, obstetric block after
achievement of maternal locoregional anesthesia peri-rachianesthesia, skin disinfection and
sterile field. The gesture will be performed by an experienced obstetrician under ultrasound
guidance. Anesthetist-resuscitator is present in the obstetric block. Peri-rachianesthesia is
performed by the initial injection of 2.5mg of hyperbaric bupivacaine associated with 5 gamma
of Sufentanil and 0.5ml of physiological saline.
Inclusion in one of two arms is defined after randomization in single blind:
Arm 1 (Sufentanil + Lidocaïne) or Arm 2 (Ultiva® + Lidocaïne) For patients randomized in the
arm 1, we will realize the reference protocol, as in the current practice, by injecting
Sufentanil intra-cordally at the posology of 1,5 μg / kg of estimated fetal weight, then
Lidocaïne 1% in 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 100 mg of Lidocaïne 1% into a 10 ml bolus. In case of failure of the
procedure, we will inject 10ml of KCL 10% intra-cordial if the cord is still accessible, if
not intra-cardiac.
For patients randomized to arm 2, we will intracenally inject Ultiva® 30 μg and Lidocaïne 1%
into 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 10 ml bolus. In case of failure of the
procedure, we will inject 10 ml of KCL 10% intra-cordally if the cord is still accessible, if
not intra-cardiac.
