CERVICAL PREPARATION UNDER PARACERVICAL BLOCK FOR THE ABORTION OF FIRST TRIMESTER: RANDOMIZED TRIA

Phase 1

• Conditions: The women are 18 years old or more, wishing an abortion under local anesthesia, between 6 and 14 weeks the day of the abortion.; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-003753-14-FR
• Lead Sponsor: Assistance Publique Hôpitaux de Marseille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-23
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

Women aged 18 or over;
Woman with a single intrauterine pregnancy, the term is between 6SA and strictly less than 14 weeks on the day of the abortion, estimated by ultrasound measurement of the cranio-caudal length of between 5 and 84 millimeters;
Female looking for abortions under local anesthesia;
Women who have signed a written informed consent and agreeing to abide by the instructions of the protocol.
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 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Woman wishing to interrupt her participation in the study before the end;
Woman for whom surgery was not performed (no show the patient the day of surgery, miscarriage before the operation).
Women who have not followed the protocol (not taken for a product).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified