Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403982
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-08
First Post:
2024-04-30
Brief Title:
The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia
Sponsor:
Central Clinical Hospital of the Ministry of Internal Affairs and Administration Warsaw Poland
Organization:
Central Clinical Hospital of the Ministry of Internal Affairs and Administration Warsaw Poland
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
Detailed 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 n100 in which the use of oxytocin will be continued after the administration of ELA or to the control group n100 in which the oxytocin will be changed to 09 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 eg mode of the delivery duration of labor Apgar score umbilical artery blood gas analysis will also be recorded
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 eg mode of the delivery duration of labor Apgar score umbilical artery blood gas analysis will also be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None