Differences in maternal temperature and saturation after administration of remifentanil PCA or epidural analgesia during labor - differences in maternal temperature and saturation after administration of remifentanil PCA or epidu

Conditions: laborpain
MedDRA version: 9.1Level: LLTClassification code 10052803Term: Analgesic effect

Registration Number: EUCTR2008-002792-28-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

•Age =18 years
•Between 37-42 weeks of gestation
•Singleton pregnancy
•ASA physical status I or II

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Prior administration of regional of opioid analgesia (during this delivery).
•Morbid obesity (BMI = 40 kg/m2)
•Drug allergy: history of hypersensitivity to opioid or local anesthetic substances
•High risk pregnancy: including severe asthma (daily use of medication), insulin dependent diabetes, severe pre-eclampsia (proteinuria = 5 grams)
•Use of antibiotics during delivery
•Initial maternal SpO2 of less than 98%
•Initial maternal temperature of 38°C or higher.
•Cervical dilation of > 7 cm
•Ruptured membranes for more than 24 hours at time of inclusion
•Contraindication for epidural analgesia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): •Maternal temperature<br>•Maternal saturation<br><br>;Main Objective: The main objective of this study is to compare the side effects of remifentanil, administered intravenous patient-controlled, with those of epidural analgesia.<br>The evaluation will be based upon the following outcome parameters:<br><br>•Maternal temperature<br>•Maternal saturation<br><br>;Secondary Objective: •To compare the incidences of other known side effects, in particular nausea, pruritus, sedation and hypotension.<br>•Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone.<br><br>

Secondary Outcome Measures