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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29662

Enrollment

175

Registered

2008-10-20

Start date

2008-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

labor pain, labour pain, saturation, temperature, epidural analgesia, remifentanil baringspijn, saturatie, temperatuur, epiduraal

Interventions

All patients will enter the study in a control group (group with no analgesia). Patients requesting analgesia, will be randomized to one of two study groups: 1. remifentanil patient controlled analg

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years and older 2. Between 24-42 weeks of gestation 3. ASA I or II

Exclusion criteria

Exclusion criteria: 1. Prior administration of regional or opioid analgesia (during this delivery) 2. Morbid obesity (BMI > 40kg/m2) 3. Drug allergy: history of hypersensitivity to opioid or local anesthetic substances 4. Severe pre-eclampsia (proteinuria > 5 grams) 5. Use of antibiotics during delivery 6. Initial maternal SpO2 of less than 98% 7. Initial maternal temperature of 38 C or higher 8. Cervical dilation of > 7cm 9. Ruptured membranes for more than 24 hours at time of inclusion 10. Contraindication for epidural analgesia

Design outcomes

Primary

Measure	Time frame
Main objective is to compare the side effects of remifentanil PCA with those of epidural analgesia. The evaluation will be based upon the following parameters: 1. maternal temperature 2. maternal saturation	—

Secondary

Measure	Time frame
The secondary objective: To compare other known side effects, in particular; - nausea - pruritus - sedation - hypotension Fetal oucome as determined by: - Apgar scores - umbilical cord pH - NACS - requirement naloxone	—

Contacts

Public ContactM.R. Douma

Leiden University Medical Center Department of Anesthesiology P.O. Box 9600

maritdouma@hotmail.com0031 (0)6 14276591

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)