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

NCT06403982 | Enrolling By Invitation

• 1 other identifier: KB 26/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Contraction; Oxytocin; Labor Progress; Fetal Doppler; Labor Epidural Analgesia; Labor Pain

Keywords

epidural anaesthesia; use of oxytocin; uterine contractions; fetal well-being; fetal doppler; ctg; fetal monitoring; labor analgesia; labor pain; labor progression

Outcome Measures

Primary Outcomes (3)

• Changes in CTG pattern

  E.g. changes in fetal heart rate, presence of cycling, presence of decelerations, STV value in both arms

  During the first two hours after the enrollment

• Maternal-Fetal Doppler

  The PI values in uterine arteries, umbilical artery and fetal middle cerebral artery

  From the enrollment to the first day after the delivery

• Labour progression

  The change in cervical dilation

  The first two hours after the enrollment

Secondary Outcomes (7)

• Duration of labor

  From the enrollment to two hours after the delivery

• Mode of the delivery

  At the time of delivery

• Umbilical cord blood gasometry

  At the delivery

• Apgar score

  At the delivery of newborn

• Birth weight of the newborn

  At the delivery

Study Arms (2)

Oxytocin Group

EXPERIMENTAL

Oxytocin Group will comprise 100 women in labor either stimulated or induced by oxytocin requesting epidural analgesia (ELA). The use of oxytocin will be continued after the administration of ELA.

Other: Continuation of oxytocin after ELA

Control Group

PLACEBO COMPARATOR

Control Group will comprise 100 women in labor either stimulated or induced by oxytocin requesting epidural analgesia (ELA). The oxytocin pump will be changed to 0.9% sodium chloride solution pump after the administration of ELA.

Other: Discontinuation of oxytocin after ELA

Interventions

Continuation of oxytocin after ELA OTHER

The use of oxytocin will be continued after the administration of ELA. 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. Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

Oxytocin Group

Discontinuation of oxytocin after ELA OTHER

The oxytocin pump will be changed to 0.9% sodium chloride solution pump after the administration of ELA. 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. Additionally, the velocities in the uterine arteries will be measured during the first day after the delivery.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland: lead
• Medical University of Warsaw: collaborator

Study Sites (1)

Clinical Department of Obstetrics and Perinatology, National Medical Institute of the Ministry of the Interior and Administration

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Related Publications (4)

• Ye Y, Song X, Liu L, Shi SQ, Garfield RE, Zhang G, Liu H. Effects of Patient-Controlled Epidural Analgesia on Uterine Electromyography During Spontaneous Onset of Labor in Term Nulliparous Women. Reprod Sci. 2015 Nov;22(11):1350-7. doi: 10.1177/1933719115578926. Epub 2015 Mar 29.

  PMID: 25824008 BACKGROUND

• Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.

  PMID: 29781504 BACKGROUND

• Lurie S, Feinstein M, Heifetz C, Mamet Y. Epidural analgesia for labor pain is not associated with a decreased frequency of uterine activity. Int J Gynaecol Obstet. 1999 May;65(2):125-7. doi: 10.1016/s0020-7292(99)00005-3.

  PMID: 10405055 BACKGROUND

• Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6.

  PMID: 19104358 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 8, 2024
• Study Start: May 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Study protocol will be available following its publication. The anonymized participant data will become available upon publishing the protocol and the results of the study.
• Access Criteria: The data will be provided on reasonable request. (contact details: joanna.krol@wum.edu.pl).

Locations

PL (1)