Anesthesia, EpiduralPhase 4NCT03344042
Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour
A Phase 4 study testing Fentanyl and Sufentanil in people with Anesthesia, Epidural and Opioid, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia, Epidural, Opioid, Labor Pain
- What is being tested?
- Fentanyl and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2017to 20 Dec 2018
- Phase
- Phase 4
- 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
- parturient in labour without cervical dilation and regular uterine contractions
Who cannot join
- no consent
- known allergy to administered opioid
- contraindications to epidural analgesia
- coagulopathies including platelet count of less than 100,000
- spine surgery in past
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM
Warsaw, Masovian Voivodeship, 02-015
Jan Bilawicz, MD, 0048 22 583 03 81, bilawicz@wp.pl
About this study
Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.
- Conditions
- Anesthesia, Epidural, Opioid, Labor Pain
- Being tested
- Fentanyl, Sufentanil
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
100mcg Fentanyl
SufentanilDrug
10mcg sufentanil
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | 100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation Receives: Drug: Fentanyl |
| Sufentanyl | Active comparator | 10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation Receives: Drug: Sufentanil |
| Control | No intervention | No epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity according to Numerical Rating Scale (NRS)
till 4cm cervical dilation in primigravida or 3cm multiparous
Measured: up to 24 hours
Secondary outcomes (3)
Fetal heart rate
till 4cm cervical dilation in primigravida or 3cm multiparous
Measured: up to 24 hours
Blood pressure parturient
till 4cm cervical dilation in primigravida or 3cm multiparous
Measured: up to 24 hours
Heart rate of parturient
till 4cm cervical dilation in primigravida or 3cm multiparous
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2017
- Primary completion20 Dec 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EpiduralStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Biławicz, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344042
- Sponsor's protocol ID
- KB/46/2016
- Status last verified
- Dec 2018
- First submitted
- 16 Aug 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour
- ClinicalTrials.gov ID
- NCT03344042
- Acronym / sponsor ID
- KB/46/2016
- Conditions
- Anesthesia, Epidural, Opioid, Labor Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 20 Dec 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 17 Nov 2017 (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.
Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: Fentanyl100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation |
| Sufentanyl | Active comparator | Drug: Sufentanil10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation |
| Control | No intervention | –No epidural analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- parturient in labour without cervical dilation and regular uterine contractions
Key exclusion criteria (5 listed)
- no consent
- known allergy to administered opioid
- contraindications to epidural analgesia
- coagulopathies including platelet count of less than 100,000
- spine surgery in past
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 |
|---|---|---|
| Fentanyl100mcg Fentanyl | Drug | Fentanyl |
| Sufentanil10mcg sufentanil | Drug | Sufentanyl |
Primary outcome
Pain intensity according to Numerical Rating Scale (NRS)
Time frame: up to 24 hours
till 4cm cervical dilation in primigravida or 3cm multiparous
3 secondary outcomes
Fetal heart rate
Time frame: up to 24 hours
Blood pressure parturient
Time frame: up to 24 hours
Heart rate of parturient
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Sufentanil in people with Anesthesia, Epidural and Opioid, run by Medical University of Warsaw 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 1 inclusion and 5 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 6 Dec 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jan Bilawicz, MD (0048225830381, bilawicz@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity according to Numerical Rating Scale (NRS) (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2018.