MEOPA (equimolar mixture of oxygen and protoxide of nitrogen) versus local anesthetic for analgesia during the biopsy of trophoblast

MEOPA (equimolar mixture of oxygen and protoxide of nitrogen) versus local anesthetic for analgesia during the biopsy of trophoblast. - MELIBIO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005361-12-FR

Enrollment

240

Registered

2013-06-19

Start date

2013-03-07

Completion date

Unknown

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and biopsy of trophoblast

Interventions

Trade Name: KALINOX Product Name: KALINOX Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion Trade Name: LIDOCAINE Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Medical indication of biopsy of trophoblast Monofoetal pregnancy First quarter of pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Contraindication of the realization of biopsy of trophoblast Contraindication of the use of MEOPA or KALINOX Contraindication of the use of local anesthetic

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine if the efficiency of the analgesia by MEOPA si equivalent at least to that of the local anesthetic in the biopsy of trophoblast during the first quarter of the pregnancy. The main criteria of evaluation will be represented by the efficiency of the analgesia measured through an analog visual scale of the pain in the immediate fall of the realization of the biopsy of trophoblast;Secondary Objective: The secondary criteria of evaluation will be represented by the evaluation of the anxiety, the disconfort and the pain felt before, during and after the act.;Primary end point(s): End of study : visit of the last patient (240th patient);Timepoint(s) of evaluation of this end point: After 36 months of the duration of the study	—

Measure

Time frame

Main Objective: Determine if the efficiency of the analgesia by MEOPA si equivalent at least to that of the local anesthetic in the biopsy of trophoblast during the first quarter of the pregnancy. The main criteria of evaluation will be represented by the efficiency of the analgesia measured through an analog visual scale of the pain in the immediate fall of the realization of the biopsy of trophoblast;Secondary Objective: The secondary criteria of evaluation will be represented by the evaluation of the anxiety, the disconfort and the pain felt before, during and after the act.;Primary end point(s): End of study : visit of the last patient (240th patient);Timepoint(s) of evaluation of this end point: After 36 months of the duration of the study

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: February 2016	—

Countries

France

Contacts

Public ContactClinical Research Department

HOPITAL SAINT JOSEPH

mraffray@hopital-saint-joseph.fr0033491806516

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026