BREAST FEEDING MedDRA version: 9.1 Level: LLT Classification code 10006248 Term: Breast feeding problem (infant)
Conditions
Interventions
Trade Name: SUFENTA
Pharmaceutical Form: Injection*
INN or Proposed INN: LEVOBUPIVACAINE
Other descriptive name: CHIROCAINE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Sponsors
ERASME HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PRIMIPARE MOTHER 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: GESTATIONAL AGE LESS THAN 37 WEEKS MOTHER LESS THAN 18 YEARS OF AGE NO PRE-ECLAMPSIA MOTHER AT LEAST 155 CM IN HEIGHT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO INVESTGATE THE INFLUENCE OF EPIDURAL INJECTION OF SUFENTANIL DURING LABOR ON THE CAPABILITIES OF THE INFANT TO BE BREAST FED;Secondary Objective: TO INVESTGATE THE INFLUENCE OF EPIDURAL INJECTION OF SUFENTANIL DURING LABOR TO BE SOLELY BREAST FED AT DISCHARGE FROM HOSPITAL;Primary end point(s): TO MEASURE THE EASINESS AND WILLIGNESS OF THE NEW BORN INFANT (LESS THAN 24 HOURS OF AGE) TO BE EXLUSIVELY BREST FED, EVEN IN THE EVNT OF THE INJECTION OF EPIDURAL SUFENTANIL IN THE MOTHER DURING LABOR | — |
Countries
Belgium
Outcome results
None listed