Uterine ContractionNCT06403982
The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia
A study testing Continuation of oxytocin after ELA and Discontinuation of oxytocin after ELA in people with Uterine Contraction and Oxytocin, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Contraction, Oxytocin, Labor Progress
- What is being tested?
- Continuation of oxytocin after ELA and Discontinuation of oxytocin after ELA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 6 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 9Show fewer
- patient not requesting or not eligible for epidural analgesia
- informed consent form not signed
- spontaneous labor without the use of oxytocin
Trial locations and contacts
1 site in 1 country.
Poland1 site
Clinical Department of Obstetrics and Perinatology, National Medical Institute of the Ministry of the Interior and Administration
Warsaw, Masovian Voivodeship, 02-507
About this study
Official title: The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia - a Randomized Controlled Trial
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.
Read more
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.
Read the 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 (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.
- Conditions
- Uterine Contraction, Oxytocin, Labor Progress, Fetal Doppler, Labor Epidural Analgesia, Labor Pain
- Being tested
- Continuation of oxytocin after ELA, Discontinuation of oxytocin after ELA
- Keywords
- epidural anaesthesia, use of oxytocin, uterine contractions, fetal well-being, fetal doppler, ctg, fetal monitoring, labor analgesia, labor pain, labor progression
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuation of oxytocin after ELAOther
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.
Discontinuation of oxytocin after ELAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Discontinuation of oxytocin after ELA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CTG pattern
E.g. changes in fetal heart rate, presence of cycling, presence of decelerations, STV value in both arms
Measured: During the first two hours after the enrollment
Maternal-Fetal Doppler
The PI values in uterine arteries, umbilical artery and fetal middle cerebral artery
Measured: From the enrollment to the first day after the delivery
Labour progression
The change in cervical dilation
Measured: The first two hours after the enrollment
Secondary outcomes (7)
Duration of labor
Duration of first and second stages of labor
Measured: From the enrollment to two hours after the delivery
Mode of the delivery
Vaginal Birth or Assisted vaginal birth or Caesarean section
Measured: At the time of delivery
Umbilical cord blood gasometry
The result of umbilical cord blood gasometry at the delivery
Measured: At the delivery
Apgar score
Newborn Apgar score in 1, 3 and 5th minute
Measured: At the delivery of newborn
Birth weight of the newborn
Birth weight of the newborn
Measured: At the delivery
Presence of Neonatal Complications
hospitalization at neonatal intensive care unit, infections, respiratory or neurological disorders etc.
Measured: From the delivery to the hospital discharge of the newborn
Presence of labor complications
Lack of labor progress, Postpartum hemorrhage, Fetal distress, Placental abruption etc.
Measured: From enrollment up to two hours after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start6 May 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine ContractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw
- Responsible party
- Principal investigator, Król Joanna, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403982
- Sponsor's protocol ID
- KB 26/2024
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request
Publications
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.
PubMed 25824008Anim-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.
PubMed 29781504Lurie 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.
PubMed 10405055Abrao 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.
PubMed 19104358
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06403982
- Acronym / sponsor ID
- KB 26/2024
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Medical University of Warsaw
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin Group | Experimental | Other: Continuation of oxytocin after ELAOxytocin 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. |
| Control Group | Placebo comparator | Other: Discontinuation of oxytocin after ELAControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years old
- singleton pregnancy
- labor induced by oxytocin or stimulated with oxytocin
- signed informed consent form
- cervical dilation ≥ 3cm
Key exclusion criteria (9 listed)
- less than 18 years old
- preterm delivery
- multiple pregnancy
- fetal malformations
- less than 3cm cervical dilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuation of oxytocin after ELAThe 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. | Other | Oxytocin Group |
| Discontinuation of oxytocin after ELAThe 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. | Other | Control Group |
Primary outcome
Changes in CTG pattern
Time frame: During the first two hours after the enrollment
E.g. changes in fetal heart rate, presence of cycling, presence of decelerations, STV value in both arms
Maternal-Fetal Doppler
Time frame: From the enrollment to the first day after the delivery
The PI values in uterine arteries, umbilical artery and fetal middle cerebral artery
Labour progression
Time frame: The first two hours after the enrollment
The change in cervical dilation
7 secondary outcomes
Duration of labor
Time frame: From the enrollment to two hours after the delivery
Mode of the delivery
Time frame: At the time of delivery
Umbilical cord blood gasometry
Time frame: At the delivery
Apgar score
Time frame: At the delivery of newborn
Birth weight of the newborn
Time frame: At the delivery
Presence of Neonatal Complications
Time frame: From the delivery to the hospital discharge of the newborn
Presence of labor complications
Time frame: From enrollment up to two hours after the delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 25824008Ye 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.
- Background: PubMed 29781504Anim-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.
- Background: PubMed 10405055Lurie 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.
- Background: PubMed 19104358Abrao 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.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuation of oxytocin after ELA and Discontinuation of oxytocin after ELA in people with Uterine Contraction and Oxytocin, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in CTG pattern (time frame: During the first two hours after the enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403982, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.