Painless Vainal LabourPhase 4NCT05840328
DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY
A Phase 4 study testing Dexmedetomidine Injection [Precedex] and Bupivacaine Injection in people with Painless Vainal Labour, run by Menoufia University at 1 site in Egypt.
Trial summary
compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor Read more about this study
- Who is it for?
- Ages 19 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Painless Vainal Labour
- What is being tested?
- Dexmedetomidine Injection [Precedex] and Bupivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2022to 5 Jul 2023
- 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 19 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full term (≥ 37 weeks) healthy primigravida parturients ASA2
- with single fetus scheduled for vaginal delivery
- with cephalic presentation
- requesting labor analgesia.
Who cannot join
- Allergy to dexmetomidine.(based on previous history)
- Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
- Twins.
- Malpresentation.
- Preeclampsia or gestational hypertension
- Uncontrolled diabetes HBA1c ≥ 6.5%
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- Uncontrolled renal failure
- Uncontrolled liver disease
- Bleeding tendency or coagulopathy.
- Contraindication or patient refusal to epidural block.
- Body mass index ≥ 35.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University Hospitals
Shibīn al Kawm, Menoufia, 32513
Ghada Ali, 01001775783, ghadaali132@yahoo.com
ashraf m eskandr
About this study
Official title: INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY
compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor
- Conditions
- Painless Vainal Labour
- Being tested
- Dexmedetomidine Injection [Precedex], Bupivacaine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
interventional drug will be administred either intravenously or epidurally
Bupivacaine InjectionDrug
intervention drug will be administred epidurally
| Study group | Role | What they receive |
|---|---|---|
| plan group | Placebo comparator | bupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \hr. Receives: Drug: Bupivacaine Injection |
| epidural group | Active comparator | 10 ml of 0.125 % buoivacaine with 0.5 µg\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\hr Receives: Drug: Dexmedetomidine Injection [Precedex]; Drug: Bupivacaine Injection |
| intravenous group | Active comparator | continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine Receives: Drug: Dexmedetomidine Injection [Precedex]; Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
VAS score from 0 to 10 will be assesed
Measured: at 30 min after induction of block
pain relief
VAS score from 0 to 10
Measured: on delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start5 Dec 2022
- Primary completion5 Jun 2023 (estimated)
- Study completion5 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painless Vainal LabourStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
- Investigators
- mostafa M mansour, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840328
- Sponsor's protocol ID
- 11/2022ANET49
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY
- ClinicalTrials.gov ID
- NCT05840328
- Acronym / sponsor ID
- 11/2022ANET49
- Conditions
- Painless Vainal Labour
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 5 Jun 2023 (estimated)
- Study completion
- 5 Jul 2023 (estimated)
- First posted
- 3 May 2023 (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.
compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| plan group | Placebo comparator | Drug: Bupivacaine Injectionbupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \hr. |
| epidural group | Active comparator | Drug: Dexmedetomidine Injection [Precedex], Drug: Bupivacaine Injection10 ml of 0.125 % buoivacaine with 0.5 µg\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\hr |
| intravenous group | Active comparator | Drug: Dexmedetomidine Injection [Precedex], Drug: Bupivacaine Injectioncontinuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Full term (≥ 37 weeks) healthy primigravida parturients ASA2
- with single fetus scheduled for vaginal delivery
- with cephalic presentation
- requesting labor analgesia.
Key exclusion criteria (11 listed)
- Allergy to dexmetomidine.(based on previous history)
- Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
- Twins.
- Malpresentation.
- Preeclampsia or gestational hypertension
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 |
|---|---|---|
| Dexmedetomidine Injection [Precedex]interventional drug will be administred either intravenously or epidurally | Drug | epidural group, intravenous group |
| Bupivacaine Injectionintervention drug will be administred epidurally | Drug | epidural group, intravenous group, plan group |
Primary outcome
pain relief
Time frame: at 30 min after induction of block
VAS score from 0 to 10 will be assesed
pain relief
Time frame: on delivery
VAS score from 0 to 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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.
mostafa M mansour, MD principal investigator
Menoufia University
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 Dexmedetomidine Injection [Precedex] and Bupivacaine Injection in people with Painless Vainal Labour, run by Menoufia University at 1 site in Egypt.
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 4 inclusion and 11 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 3 May 2023. 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 Egypt. 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.
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 mostafa S mansour, MD (01225484055, mostafa.said@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief (time frame: at 30 min after induction of block). The study lists 2 primary outcomes in all. 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 3 May 2023.