Study of oxycodone safety and effectiveness for pain relief during labor and its effects on newborns

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What is this study about?

This study focuses on managing labor pain during childbirth using oxycodone, a pain-relieving medication. The research examines how this medication works during labor and its effects on both the mother and newborn. Oxycodone hydrochloride is given as an injection under the skin to help control pain during childbirth.

The main purpose of this research is to study how oxycodone moves through the body of women in labor and measure its levels in both the mother’s blood and the umbilical cord at the time of birth. The medication will be administered as a solution for injection with careful monitoring of the maximum daily dose. The treatment period lasts up to two days, during which the medication’s effectiveness and safety will be evaluated.

During the study, researchers will collect blood samples from mothers and umbilical cords to measure medication levels. This information will help create a model showing how the medication behaves in the bodies of women during labor. The research aims to better understand the use of this pain medication during childbirth and its safety for both mother and baby.

1 Initial pain treatment

During labor, you will receive Oxanest® (oxycodone) as an injection under the skin for pain relief

The medication will be administered through subcutaneous injection (injection under the skin) at 10 mg/ml concentration

2 Birth and sample collection

At the time of birth, a blood sample will be collected from you

A blood sample will also be collected from the umbilical cord (the cord connecting mother and baby)

3 Concentration measurement

The collected blood samples will be analyzed to measure the levels of oxycodone

The analysis will compare the amount of medication in your blood and the umbilical cord blood

4 Data analysis

Your blood test results will be used to create a mathematical model showing how the medication moves through the body during labor

This step does not require any additional actions from you

5 Study completion

Your participation in the study ends after the blood samples are collected

The total study period runs from July 2024 to July 2025

Who Can Join the Study?

  • Must be 18 years or older
  • Must be a pregnant woman in labor
  • Must have received oxycodone (a pain medication) for labor pain management
  • Must be able to understand and provide informed consent (written agreement to participate after understanding study details)
  • Must be willing to allow collection of blood samples from mother and umbilical cord after birth
  • Must be mentally capable of making independent decisions about participation
  • Must understand that participation is completely voluntary
  • Must be able to communicate effectively with the research team

Who Cannot Join the Study?

  • Age below 18 years or above 55 years
  • Male patients (study is for females only)
  • Known allergies or hypersensitivity to oxycodone or similar pain medications
  • Multiple pregnancy (carrying more than one baby)
  • Severe medical conditions that could affect labor or delivery
  • Current use of medications that could interact with oxycodone
  • Contraindications (medical reasons not to use) for opioid pain medications
  • History of substance abuse or addiction
  • Inability to provide informed consent
  • Participation in other clinical trials within the past 30 days
  • Significant liver or kidney problems
  • Pre-eclampsia (high blood pressure during pregnancy)
  • Planned cesarean section
  • Known fetal abnormalities
  • Inability to understand or follow study instructions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Pohjois-Savon hyvinvointialue Kuopio Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
01.07.2024

Trial locations

Oxycodone is a strong pain-relieving medication that belongs to the opioid family. In this trial, it is used to manage labor pain during childbirth. The medication works by binding to specific receptors in the brain and nervous system to reduce pain sensation. It can provide effective pain relief for women during labor, though it may pass through the placenta and reach the baby, which is why this study focuses on both maternal and newborn effects.

Investigated diseases:

Labor – A natural physiological process during which the uterus contracts to deliver a baby through the birth canal. It typically begins with regular uterine contractions that increase in frequency and intensity. Labor progresses through several stages, starting with the thinning and opening of the cervix, followed by the descent of the baby through the birth canal, and ending with the delivery of the placenta. The process can last anywhere from a few hours to over a day. Physical changes include cervical dilation, effacement, and the release of various hormones that regulate the process.

Trial ID:
2024-516495-15-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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