women during labor MedDRA version: 15.0 Level: HLT Classification code 10029772 Term: Normal pregnancy, labour and delivery System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: ULTIVA*IV 5FL 1MG 3ML
Pharmaceutical Form: Powder for injection
INN or Proposed INN: REMIFENTANIL HYDROCHLORIDE
CAS Number: 132539-07-2
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - woman in labor with contraindication for peridural analgesia; particularly: ? impaired blood coagulation parameters or impaired platelets count ? hypovolemia (unresponsive to pharmacological treatment) ? sepsis ? infection in the site of insertion of the peridural catheter ? tattoo in the site of insertion of the peridural catheter ? allergy to local anesthetics ? intracranial hypertension ? neurological disease in active phase - lack of consent (preference for less invasive methods) - ASA I or II - cervical dilatation =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - previous treatment with analgesic drugs - pre-eclampsia - insulin-dependent diabetes - toxic substance abuse - opioids allergy - pathological obesity (BMI > 40)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare analgesic efficacy of continuous vs intermittent administration of remifentanil at the end of the first hour of labor;Secondary Objective: - to compare analgesic efficacy of continuous vs intermittent administration of remifentanil during the whole labor - to compare the incidence of maternal and neonatal side effects associated with the use of these two methods - to compare mother’s level of satisfaction towards these two methods at the end of labor;Primary end point(s): in each woman pain will be measured through the administration of a VAS with values from 0 to 10; this evaluation will be done at the beginning of the analgesia and after 60 minutes;Timepoint(s) of evaluation of this end point: 1 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - in each woman pain will be measured through the administration of a VAS with values from 0 to 10; this evaluation will be done at the beginning of the analgesia, after 5 minutes and every 30 minutes until the end of labor; - the sedation will be measured through sedation score at the beginning of the analgesia and every 60 minutes until the end of labor; - woman’s vital signs will be measured at the beginning of labor, every 5 minutes until the first half hour and then every 30 minutes until the end of labor by instruments routinely present in delivery rooms. Particularly heart rate will be evaluated by 3-leads ECG, blood pressure by sphygmomanometers, arterial oxygen saturation by infrared pulse oximetry and respiratory rate by direct measurement; - mother’s episods of nausea, vomiting or pruritus will be recorded. - fetal heart rate will be measured by cardiotocography continuously during the labor; in particular decreases in heart rate above 20% in respect to time zero (if not associated with uterine contractions) will be sought; - fetal vitality and fetal primary vital functions will be evaluated through Apgar score at the first and fifth minute. A blood gas analysis on the cord blood with cooximetric method and fetal pH will be recorded at the 15th minute and after 2 hours; - In each woman the overall efficacy of these two methods in improving patients’ comfort during the labor will be evaluated through an anonimous satisfaction form with a 5-points evaluation scale.;Timepoint(s) of evaluation of this end point: whole length of labor | — |
Countries
Italy
Contacts
Public Contactsod anestesia DAIMI
azienda ospedaliero-universitaria careggi
Outcome results
None listed