The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia

Labor Pain Clinical Trial

Official title: The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia - a Randomized Controlled Trial

Status Enrolling by invitation

Clinical Trial Summary

The aim of this study is to determine the influence of oxytocin on fetal well-being during labor in patients receiving epidural analgesia (ELA) with the use of cardiotocography (CTG) and doppler ultrasonography.

CTG is a commonly used technique to monitor the fetal heartbeat and contractions of uterus during pregnancy and labor. The maternal-fetal doppler ultrasonography is a non-invasive method used for the pregnancy surveillance.

Various psychological and psychosocial factors impact the perception of labor pain. Its intensity is described differently by each patient - some claim it to be the worst pain that they experienced during their lives. Usually, the labor pain is more severely experienced by the patients giving birth for the first time and those with induced labor.

Nowadays, there are many non-pharmacological (e.g. acupuncture, massage, TENS) and pharmacological (anesthetic gas, opioids, ELA) methods of labor pain management. ELA is a regional anesthesia, in which the anesthetic drug is injected into the epidural space with the aim to block the pain experienced by the patient without impacting patients ability to move or push during labor. The safety of the procedure is well-discussed and documented in Cochrane review from 2018, which shows no adverse impact on the proportions of Caesarean section, long-term backache, or neonatal outcomes. It is considered to be a golden standard for labor pain management.

Oxytocin is a well-known hormone used for the induction of labor and to stimulate the uterine contraction during labor. The impact of oxytocin alone on CTG pattern and maternal-fetal doppler ultrasonography is discussed in the literature. However, the cumulative effect of ELA and oxytocin remains unclear. Some researchers claim that ELA increases the frequency of uterine contractions and that the additional use of oxytocin leads to higher risk of uterine hyper-stimulation and unreassuring CTG patterns. Whereas the others state that ELA weakens the strength of uterine contractions leading to slow progression of labor and the need to use or increase the use of oxytocin.

There are no data on how the cumulative use of oxytocin and ELA impacts the maternal-fetal flows during labor.

Clinical Trial Description

This is a randomized controlled trial performed at the Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration. The study will recruit 200 patients in either labor induced by oxytocin or stimulated with oxytocin at 37-42 weeks of gestation, requesting the epidural labor analgesia (ELA) and meeting the inclusion criteria. The patients will be individually randomized to either the study group (n=100), in which the use of oxytocin will be continued after the administration of ELA; or to the control group (n=100), in which the oxytocin will be changed to 0.9% sodium chloride solution after the ELA administration.

The vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery will be measured directly before the administration of ELA and then after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor. If no progress is detected due to the secondary weakening of uterus contractile function, the oxytocin will be reintroduced in the control group.

Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

The labor and neonatal outcomes (e.g mode of the delivery, duration of labor, Apgar score, umbilical artery blood gas analysis) will also be recorded. ;

Related Conditions & MeSH terms

• Labor Epidural Analgesia
• Labor Pain
• Labor Progress
• Oxytocin
• Uterine Contraction

• NCT number: NCT06403982
• Study type: Interventional
• Source: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 6, 2024
• Completion date: December 31, 2025