Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06403982
Other study ID # KB 26/2024
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 6, 2024
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Labour progression The change in cervical dilation The first two hours after the enrollment
Secondary Duration of labor Duration of first and second stages of labor From the enrollment to two hours after the delivery
Secondary Mode of the delivery Vaginal Birth or Assisted vaginal birth or Caesarean section At the time of delivery
Secondary Umbilical cord blood gasometry The result of umbilical cord blood gasometry at the delivery At the delivery
Secondary Apgar score Newborn Apgar score in 1, 3 and 5th minute At the delivery of newborn
Secondary Birth weight of the newborn Birth weight of the newborn At the delivery
Secondary Presence of Neonatal Complications hospitalization at neonatal intensive care unit, infections, respiratory or neurological disorders etc. From the delivery to the hospital discharge of the newborn
Secondary Presence of labor complications Lack of labor progress, Postpartum hemorrhage, Fetal distress, Placental abruption etc. From enrollment up to two hours after the delivery
See also
  Status Clinical Trial Phase
Completed NCT03539562 - Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Withdrawn NCT04662450 - Evaluation and Management of Parturients' Pain Intensity N/A
Completed NCT02885350 - Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour Phase 4
Completed NCT02550262 - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor N/A
Completed NCT01598506 - Intrathecal Hydromorphone for Labor Analgesia Phase 2
Withdrawn NCT01636999 - Comparing Sedara to Butorphanol in Early Labor N/A
Completed NCT00987441 - Epidural Labor Analgesia and Infant Neurobehavior N/A
Completed NCT00755092 - Effect of Doula in Nulliparas and Multiparas N/A
Terminated NCT00787176 - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes N/A
Recruiting NCT06036797 - Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia Phase 2
Completed NCT05512065 - Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women N/A
Completed NCT05327088 - Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia Phase 2
Completed NCT03103100 - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation Phase 3
Recruiting NCT03623256 - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia Phase 4
Active, not recruiting NCT02271100 - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique N/A
Completed NCT02926469 - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study N/A
Completed NCT03712735 - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women Phase 4
Not yet recruiting NCT05565274 - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients N/A
Recruiting NCT02575677 - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Recruiting NCT01708668 - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia N/A