Deambulatory Epidural During the Labour

First Pregnancy Clinical Trial

Official title:

Comparison of Two Different Peridural During the Labor and Effect of Deambulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264834
• Other study ID #: PDB001
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2014
• Est. completion date: March 20, 2018

Study information

• Verified date: May 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the concentration of local anesthetic and therefore the motor block.

Description:

Prospective, randomized and double-blind study performed on primiparous parturient divided into two distinct groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Free written consent.

• ASA I or II,

• Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation between 3-6 cm

• VAS> 30 mm

• No contraindications to peridural

Exclusion Criteria:

• Twin pregnancy, less than 36 weeks and 42 weeks

• Fetus in breech position

• Analgesia and sedation within 6h

• Contraindications to peridural

Related Conditions & MeSH terms

• First Pregnancy

Intervention

Drug:
• Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
• Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
Levobupivacaine 0.07% + Sufentanil 0.3µg/ml

Procedure:
• Lumbar epidural analgesia
Introduction of a catheter in lumbar epidural space

Locations

Country	Name	City	State
Belgium	CHUB	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Dr Madeleine Wilwerth

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between peridural application and childbirth	This will be used to assess labor.	at delivery
Primary	Caesarian	This will be used to assess labor. Was a caesarian necessary (yes-no) ?	at delivery
Primary	Instrumentalisation	This will be used to assess labor. Was an instrumentalisation (defined as the use of forceps or suction cups) necessary at delivery (yes-no) ?	at delivery
Primary	Apgar score of the baby	Evaluation of the baby, using the Apgar score. This will be used to assess labor.	at delivery
Secondary	Bromage score	Modified Bromage score (Breen et al) >5 and ability to stand on one leg alternatively. This will be used to assess perambulation (motricity).	1h after the start of the peridural
Secondary	Romberg test	Romberg test during 20-30 seconds. This will be used to assess perambulation (proprioception).	1h after the start of the peridural
Secondary	Arterial tension	Absence of orthostatic hypotension (i-e less than 20% of the usual arterial tension of the patient).	1h after the start of the peridural