First Child Delivery With Epidural Clinical Trial
Official title:
Comparison of Two Methods of Administration of the Epidural, by Programmed Intermittent Bolus or Continuous Perfusion, on the Incidence of Cesarean Sections and Instrumented Deliveries in Primiparous Women
| Verified date | May 2018 |
| Source | Brugmann University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The epidural has been recognized for many years as the most effective analgesia method for
obstetrical labor. Several different administration protocols have been evaluated over the
years with the aim of reducing side effects.
Epidurals have been incriminated in the increase of instrumented births. It is indeed
possible that the motor block induced by the epidural reduces the pelvic tonus and the
ability of the mother to push during the second stage of the labor. Furthermore, this motor
block might lead to a ill rotation of the foetal head within the pelvis, which could lead to
instrumentation (suction cups, forceps).
In the investigator's institution, an ongoing study also provided interim that showed that
the use of a low concentration of local anesthetics (as opposed to a higher concentration)
tends to decrease the instrumentation and cesarean sections rate in the institution's
population.However, the optimal administration mode of the local anesthetic in the epidural
remains unknown.
In the last few years, there has been a growing interest for a new method of administration
of the solution within the epidural, by programmed intermittent bolus. This method allows a
better distribution of the local anesthetics in the epidural space, compared to a continuous
perfusion.
This study therefore focuses on the relationship between the use of epidural with programmed
intermittent boluses and the rate of instrumented deliveries and cesarean sections.
The exact mode of administration of boluses is also subject to discussion in the literature.
One can question whether it is preferable to administer smaller boluses more frequently or
larger less frequent boluses. A few studies have investigated this issue and recommend to
administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought
after physiology (ie a wider distribution in the epidural space) and provides equivalent
analgesia to smaller, more frequent boluses.
| Status | Withdrawn |
| Enrollment | 0 |
| 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 and older |
| Eligibility |
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 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 - Language 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 score (American Society of Anesthesiologists) 3 or 4 - Foetus in transverse or seat position |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Brugmann | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Brugmann University Hospital |
Belgium,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of instrumented deliveries (suction pumps, forceps) | Number of deliveries requiring instrumentation (suction pumps, forceps) | 24h after the baby's birth | |
| Primary | Rate of cesarian sections | Number of deliveries requiring a cesarian section | 24h after the baby's birth | |
| Secondary | Number of anesthesist interventions | Number of visits of the anesthesist, either requested by the patient (request for additional analgesia by the patient because of pain during labor: the pain itself is not measured), either necessary because of side effects (nausea, pruritus). | Starting from the first injection of the epidural till the baby's birth | |
| Secondary | Maternal satisfaction | Will be assessed by means of a questionnaire (0 to 100 visual scale) | 24h after the baby's birth | |
| Secondary | Presence of a motor block | Assessed by the anesthesist with the Bromage modified scale | At the precise moment when the cervix reaches complete dilatation (10 cm opening) during labor |