The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia
Launched by CENTRAL CLINICAL HOSPITAL OF THE MINISTRY OF INTERNAL AFFAIRS AND ADMINISTRATION, WARSAW, POLAND · May 3, 2024
Trial Information
Current as of November 09, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is a randomized clinical trial in Warsaw, Poland, testing whether continuing oxytocin after epidural pain relief affects the baby and labor. About 200 pregnant adults with a single baby at term who are having labor started or helped along with oxytocin and want epidural analgesia are eligible. Key inclusion criteria include: age 18 or older, singleton pregnancy, labor induced or stimulated with oxytocin, request for epidural pain relief, cervix at least 3 cm dilated, and a normal fetal heart monitor for at least 30 minutes before epidural. Participants are randomly assigned to either keep oxytocin after the epidural or switch to a saline solution (no oxytocin). The study is designed so the participants don’t know which group they’re in.
Participants will have careful monitoring before and after the epidural, including vital signs and ultrasound checks of blood flow in the uterus and a couple of fetal arteries, before the epidural and again at 30, 60, and 120 minutes after. Labor progress will be checked about two hours after enrollment. If labor isn’t progressing in the group that stops oxytocin, oxytocin can be started again. After delivery, researchers will record outcomes such as how labor ended (vaginal birth, assisted birth, or cesarean), how long labor lasted, the baby’s Apgar scores, cord blood gases, birth weight, and any newborn problems. The trial began in 2024 and is expected to finish in 2025 at the National Medical Institute in Warsaw, with results not yet available.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • ≥ 18 years old
- • singleton pregnancy
- • labor induced by oxytocin or stimulated with oxytocin
- • signed informed consent form
- • cervical dilation ≥ 3cm
- • patient requesting and eligible for epidural analgesia
- • normal CTG trace for at least 30 minutes before epidural analgesia
- Exclusion Criteria:
- • less than 18 years old
- • preterm delivery
- • multiple pregnancy
- • fetal malformations
- • less than 3cm cervical dilation
- • lack of CTG trace for at least 30 minutes before epidural analgesia
- • patient not requesting or not eligible for epidural analgesia
- • informed consent form not signed
- • spontaneous labor without the use of oxytocin
About Central Clinical Hospital Of The Ministry Of Internal Affairs And Administration, Warsaw, Poland
The Central Clinical Hospital of the Ministry of Internal Affairs and Administration in Warsaw, Poland, is a leading medical institution dedicated to providing high-quality healthcare and advancing medical research. As a prominent clinical trial sponsor, the hospital engages in innovative studies aimed at improving patient outcomes and addressing critical health challenges. With a multidisciplinary team of experienced researchers and healthcare professionals, the hospital fosters a collaborative environment that prioritizes ethical standards and patient safety in clinical research. Its commitment to excellence and continuous improvement positions it as a key player in the advancement of medical science in Poland and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warsaw, Mazowieckie, Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported