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

Phase 1

Conditions: Pregnancy and biopsy of trophoblast
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2012-005361-12-FR

Lead Sponsor: HOPITAL SAINT JOSEPH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 240

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures