Termination of PregnancyPhase 3FOETIVA2NCT02597699
Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide
A Phase 3 study testing Remifentanil + Lidocaïne and Sufentanil + Lidocaïne in people with Termination of Pregnancy and Feticide, run by University Hospital, Montpellier at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Termination of Pregnancy, Feticide
- What is being tested?
- Remifentanil + Lidocaïne and Sufentanil + Lidocaïne
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Dec 2015to 6 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patient having given an informed consent signed before the inclusion in the trial
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Nîmes University Hospital
Nîmes, 30029
About this study
Official title: Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide: A Phase III Randomized Trial
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.
Read more
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.
Read the detailed 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.
- Conditions
- Termination of Pregnancy, Feticide
- Being tested
- Remifentanil + Lidocaïne, Sufentanil + Lidocaïne
- Keywords
- Termination of pregnancy, Feticide, Fetal pain, Remifentanil Ultiva®, Fetal asystole, Fetopathologic analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil + LidocaïneDrug
Also called Ultiva® + Xylocaïne®
Sufentanil + LidocaïneDrug
Also called Sufentanil + Xylocaïne®
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Remifentanil + Lidocaïne |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 5 minutes
Secondary outcomes (4)
The success rate of the procedure of foeticide
Fetal asystole after injection of Lidocaïne and persisted for at least 1 minute. Fetal asystole should be confirmed by the birth of a non-living fetus during delivery.
Measured: within 2 minutes after injection of Lidocaïne and persistent during at least 1 minute
The number of new punction(s) of the cordon
The number of new puncture(s) of the cord, after injection of the necessary lethal agent before persistent fetal heart failure.
Measured: 1 day
Number of side effects
Number of serious side effects in patients
Measured: 1 day
The quality of tissues (the fetopathologic analysis)
The presence of abnormal tissue(s) or cell(s) may alter the quality of the fetopathological examination. Macroscopic examination of tissues will be performed blind of the procedure used for feticide, the only anomaly described so far in feticides is the presence of whitish deposits when using KCL.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start18 Dec 2015
- Primary completion7 Mar 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Termination of PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Romy RR RAYSSIGUIER, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597699
- Sponsor's protocol ID
- 94602
- Other IDs
- 2015-002856-28, 2015
- Acronym
- FOETIVA2
- Status last verified
- Sep 2025
- First submitted
- 27 Oct 2015
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34808620
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide: A Phase III Randomized Trial
- ClinicalTrials.gov ID
- NCT02597699
- Acronym / sponsor ID
- FOETIVA2 / 94602
- Conditions
- Termination of Pregnancy, Feticide
- Keywords
- Termination of pregnancy, Feticide, Fetal pain, Remifentanil Ultiva®, Fetal asystole, Fetopathologic analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sufentanil + Lidocaïne | Active comparator | Drug: Sufentanil + LidocaïneFor 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. |
| Arm 2: Remifentanil + Lidocaïne | Experimental | Drug: Remifentanil + LidocaïneFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Patient having given an informed consent signed before the inclusion in the trial
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remifentanil + LidocaïneAlso: Ultiva® + Xylocaïne® | Drug | Arm 2: Remifentanil + Lidocaïne |
| Sufentanil + LidocaïneAlso: Sufentanil + Xylocaïne® | Drug | Arm 1: Sufentanil + Lidocaïne |
Primary outcome
The deadline of obtaining the asystole
Time frame: up to 5 minutes
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
4 secondary outcomes
The success rate of the procedure of foeticide
Time frame: within 2 minutes after injection of Lidocaïne and persistent during at least 1 minute
The number of new 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Results publication: PubMed 34808620Rayssiguier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romy RR RAYSSIGUIER, MD principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remifentanil + Lidocaïne and Sufentanil + Lidocaïne in people with Termination of Pregnancy and Feticide, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The deadline of obtaining the asystole (time frame: up to 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.