Differences in maternal temperature and saturation after administration of remifentanil PCA or epidural analgesia during labor
Phase 3
Completed
- Conditions
- labor pain10010273
- Registration Number
- NL-OMON32311
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 175
Inclusion Criteria
* Age *18 years
* Between 37-42 weeks of gestation
* Singleton pregnancy
* ASA physical status I or II
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Maternal temperature<br /><br>* Maternal saturation</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To compare the incidences of other known side effects, in particular nausea,<br /><br>pruritus, sedation and hypotension.<br /><br>* Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and<br /><br>requirement for naloxone.</p><br>