Cervical DilatationEFVDNCT02135224
the Effects of Epidural Fentanyl on Vaginal Delivery
A study testing Fentanyl and Normal saline in people with Cervical Dilatation and Bishop Score, run by University of Athens at 1 site in Greece.
Trial summary
The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cervical Dilatation, Bishop Score, Duration of Delivery
- What is being tested?
- Fentanyl and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2011to Jul 2014
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anaesthesiologists physical status I or II
- nulliparous
- normal singleton uncomplicated pregnancies of more than 38 weeks
- cephalic presentation of the fetus
- anticipated vaginal delivery
- active stage of labour
Show all 9Show fewer
- cervical dilatation between 3-5 cm
- regular uterine contractions
- normal cardiotocographic recordings.
Who cannot join
- medical problems during pregnancy
- BMI≥40 kg m-2
- opioid allergy
- prior administration of opioids or other analgesics
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieio Hospital, University of Athens
Athens, Attica, 11528
Chryssoula Staikou, c_staikou@yahoo.gr
Anteia Paraskeva, PhD
About this study
Official title: The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.
The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.
- Conditions
- Cervical Dilatation, Bishop Score, Duration of Delivery
- Being tested
- Fentanyl, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | 20 microgram per hour Receives: Drug: Fentanyl |
| Normal saline | Placebo comparator | 0.4 ml per hour Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical dilatation
Measured: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm
Secondary outcomes (1)
Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station.
Bishop score is a pre-labor scoring system which reflects the stage of the procedure (mainly the cervix condition) assessing the following: Cervical Position, Effacement, Dilation, Softness and also Fetal Station.
Measured: every 60 min from the time the first epidural dose is administered up to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startDec 2011
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DilatationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staikou Chryssoula, University of Athens
- Investigators
- Chryssoula Staikou, PhD, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135224
- Sponsor's protocol ID
- M79
- Acronym
- EFVD
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.
- ClinicalTrials.gov ID
- NCT02135224
- Acronym / sponsor ID
- EFVD / M79
- Conditions
- Cervical Dilatation, Bishop Score, Duration of Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (estimated)
- First posted
- 9 May 2014 (estimated)
- 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 study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: Fentanyl20 microgram per hour |
| Normal saline | Placebo comparator | Drug: Normal saline0.4 ml per hour |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- American Society of Anaesthesiologists physical status I or II
- nulliparous
- normal singleton uncomplicated pregnancies of more than 38 weeks
- cephalic presentation of the fetus
- anticipated vaginal delivery
Key exclusion criteria (4 listed)
- medical problems during pregnancy
- BMI≥40 kg m-2
- opioid allergy
- prior administration of opioids or other analgesics
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 |
|---|---|---|
| Fentanyl | Drug | Fentanyl |
| Normal saline | Drug | Normal saline |
Primary outcome
cervical dilatation
Time frame: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm
1 secondary outcome
Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station.
Time frame: every 60 min from the time the first epidural dose is administered up to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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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.
Chryssoula Staikou, PhD principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Normal saline in people with Cervical Dilatation and Bishop Score, run by University of Athens at 1 site in Greece.
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 9 inclusion and 4 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 9 May 2014. 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 Greece. 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?
Contact Chryssoula V Staikou, PhD (00302107286000 ext. 195, c_staikou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical dilatation (time frame: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm). 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 9 May 2014.