LaborPhase 2NCT02665936
Effect of Epidural Dexamethasone on Labor Analgesia
A Phase 2 study testing Levobupivacaine, Dexamethasone and levobupivacaine and Levobupivacaine and Dexamethasone in people with Labor, run by Kasr El Aini Hospital.
Trial summary
The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor
- What is being tested?
- Levobupivacaine, Dexamethasone and levobupivacaine and Levobupivacaine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Feb 2016
- Phase
- Phase 2
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I, II
- normal vaginal delivery In early active phase of labor
- singleton cephalic presentation at term
Who cannot join
- complicated pregnancies
- morbid obesity
- diagnosed fetal abnormalities
- contra-indications to regional anesthesia
About this study
Official title: Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study
The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.
- Conditions
- Labor
- Being tested
- Levobupivacaine, Dexamethasone and levobupivacaine, Levobupivacaine and Dexamethasone
- Keywords
- epidural analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Levobupivacaine will be given epidurally and the duration of analgesia will be calculated
Dexamethasone and levobupivacaineDrug
dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured
Levobupivacaine and DexamethasoneDrug
dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured
| Study group | Role | What they receive |
|---|---|---|
| group L | Active comparator | Epidural levobupivacaine 0.125% (Chirocaine) in normal saline in a total volume of 10 ml will be administered epidurally in active stage of labor Receives: Drug: Levobupivacaine |
| group LD4 | Active comparator | Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml Receives: Drug: Dexamethasone and levobupivacaine |
| group LD8 | Active comparator | Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml Receives: Drug: Levobupivacaine and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of epidural analgesia
Measured: an average of 5 months
Secondary outcomes (1)
Time of onset of sensory block at level T10
From the onset of active stage till the end of labor
Measured: an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed elsakka, Kasr El Aini Hospital
- Investigators
- ahmed i elsakka, m,d,, Principal investigator, Cairo Universityamira r hassan, m,d., Study chair, Cairo Universitynadia y helmy, m.d., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665936
- Sponsor's protocol ID
- wahdan
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study
- ClinicalTrials.gov ID
- NCT02665936
- Acronym / sponsor ID
- wahdan
- Conditions
- Labor
- Keywords
- epidural analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 28 Jan 2016 (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 purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group L | Active comparator | Drug: LevobupivacaineEpidural levobupivacaine 0.125% (Chirocaine) in normal saline in a total volume of 10 ml will be administered epidurally in active stage of labor |
| group LD4 | Active comparator | Drug: Dexamethasone and levobupivacaineEpidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml |
| group LD8 | Active comparator | Drug: Levobupivacaine and DexamethasoneEpidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I, II
- normal vaginal delivery In early active phase of labor
- singleton cephalic presentation at term
Key exclusion criteria (4 listed)
- complicated pregnancies
- morbid obesity
- diagnosed fetal abnormalities
- contra-indications to regional anesthesia
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 |
|---|---|---|
| LevobupivacaineLevobupivacaine will be given epidurally and the duration of analgesia will be calculated | Drug | group L |
| Dexamethasone and levobupivacainedexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured | Drug | group LD4 |
| Levobupivacaine and Dexamethasonedexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured | Drug | group LD8 |
Primary outcome
Duration of epidural analgesia
Time frame: an average of 5 months
1 secondary outcome
Time of onset of sensory block at level T10
Time frame: an average of 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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.
ahmed i elsakka, m,d, principal investigator
Cairo University
amira r hassan, m,d. study chair
Cairo University
nadia y helmy, m.d. study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levobupivacaine, Dexamethasone and levobupivacaine and Levobupivacaine and Dexamethasone in people with Labor, run by Kasr El Aini Hospital.
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 3 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Duration of epidural analgesia (time frame: an average of 5 months). 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 28 Jan 2016.