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.

Comparison of two methods of administration of the epidural, by programmed intermittent bolus or continuous perfusion, on the incidence of instrumented deliveries and cesareans in primiparous women.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000889-35-BE

Enrollment

784

Registered

2016-04-25

Start date

2016-05-26

Completion date

Unknown

Last updated

2018-03-05

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

Conditions

Fist child delivery with epidural

Interventions

Trade Name: Sufentanil Mylan Pharmaceutical Form: Solution for injection Trade Name: CHIROCAINE Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women over 18 years of age - Primiparous - Pregnancy over 36 weeks of gestational age and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Participation refusal or epidural contra-indication - Multiparous - Allergy to the products used - Twin pregnancy - Height 6 cm - ASA 3 or 4 - Foetus in transverse or seat position

Design outcomes

Primary

Measure	Time frame
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 - To assess the satisfaction of the mother - 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	—

Measure

Time frame

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 - To assess the satisfaction of the mother - 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

Measure	Time frame
Secondary end point(s): - Number of anesthesist interventions, either by patient request (pain), either by side effects monitoring - Maternal satisfaction: visual questionnaire on a scale from 0 to 100, regarding perceived analgesia and anesthesist management - 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 - Maternal satisfaction: the day after the delivery - Motor Block: at the begining of the second stage of labor, as defined as the complete cervical dilatation	—

Measure

Time frame

Secondary end point(s): - Number of anesthesist interventions, either by patient request (pain), either by side effects monitoring - Maternal satisfaction: visual questionnaire on a scale from 0 to 100, regarding perceived analgesia and anesthesist management - 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 - Maternal satisfaction: the day after the delivery - Motor Block: at the begining of the second stage of labor, as defined as the complete cervical dilatation

—

Countries

Belgium

Contacts

Public ContactAnesthesiology Service

CHU Brugmann

Philippe.VANDERLINDEN@chu-brugmann.be3224772330

Outcome results

None listed

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