Comparison of two methods of administration of the epidural, by bolus or continuous perfusion, on the incidence of cesareans and the need for instrumentation during deliveries in women having their first child.

Phase 1

Conditions: Fist child delivery with epidural
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-000889-35-BE

Lead Sponsor: Centre Hospitalier Universitaire Brugmann

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 784

Inclusion Criteria

- Women over 18 years of age
- Primiparous
- Pregnancy over 36 weeks of gestational age and <42 weeks of gestational age
- Written informed consent
- Cervical dilatation between 3 and 6 cm at recruitment
- Single pregnancy
- Foetus in cephalic position
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 784
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Participation refusal or epidural contra-indication
- Multiparous
- Allergy to the products used
- Twin pregnancy
- Height <1m55 and/or narrow pelvis, as shown by imagery
- Langage barrier
- Patients with a BMI superior or equal to 35 (computed with the weight at the beginning of the pregnancy)
- Cervical dilatation at recruitment <3 or >6 cm
- ASA 3 or 4
- Foetus in transverse or seat position

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the incidence of instrumentated deliveries and caesarean sections according to the mode of administration of the local anesthetic in the epidural.;Secondary Objective: - To determine the quality of the analgesia according to the administration mode of the epidural<br>- To assess the satisfaction of the mother<br>- To evaluate the presence of a motor block at the beginning of the second stage of the labor;Primary end point(s): Delivery mode: vaginal, instrumentated (suction cups, forceps) or caesarian section.;Timepoint(s) of evaluation of this end point: At delivery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of anesthesist interventions, either by patient request (pain), either by side effects monitoring<br>- Maternal satisfaction: visual questionnaire on a scale from 0 to 100, regarding perceived analgesia and anesthesist management<br>- Presence of a motor block: assessed by the Bromage modified score;Timepoint(s) of evaluation of this end point: - Number of anesthesist interventions: from the beginning of epidural administration by the anesthesist (T0) till delivery<br>- Maternal satisfaction: the day after the delivery<br>- Motor Block: at the begining of the second stage of labor, as defined as the complete cervical dilatation