Labor PainNCT05606952
Color Doppler to Confirm Epidural Catheter Positioning in Parturient
An observational study of Labor Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Color Doppler
- Type of treatment
- Medical device
- How many people
- 194 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 10 Nov 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: labouring pregnant women aged 18-45 years with a singleton gestation requesting epidural analgesia.
Who may be able to join
- obstetric patients admitted for epidural analgesia in the labor department suite (LDS)
Who cannot join
- Patients suffering from coagulopathy.
- Patients on recent anticoagulant therapy.
- Patients suffering from sepsis or with local sepsis at the insertion site.
- Patients with platelet count less than 100,000/dl.
- Patient refusal.
- Patient with known allergy to local anesthetic drugs
- Patients delivered by forceps.
- Patients who have undergone a cesarean section delivery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of Colour Flow Doppler for Visualization of Epidural Injectate Flow in Labouring Women: A Prospective Observational Study
The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter
Read the detailed description
patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to receive their epidural analgesia for labor pain.
A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35. All patients will be sitting to receive their epidural analgesia for labor pain.
A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1, L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.
- Conditions
- Labor Pain
- Being tested
- Color Doppler
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color DopplerDevice
Also called Epidural catheter
color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter
| Study group | Role | What they receive |
|---|---|---|
| Group (C) | patients with BMI less than 35 Receives: Device: Color Doppler | |
| Group (O) | patients with BMI more than 35 Receives: Device: Color Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
Number and percentage of patients in both groups where the flow was detected
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Dec 2022
- Primary completion1 May 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606952
- Sponsor's protocol ID
- 10/2022ANET1-2
- Status last verified
- May 2026
- First submitted
- 31 Oct 2022
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Colour Flow Doppler for Visualization of Epidural Injectate Flow in Labouring Women: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05606952
- Acronym / sponsor ID
- 10/2022ANET1-2
- Conditions
- Labor Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 7 Nov 2022 (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 calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter
Detailed description
patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to receive their epidural analgesia for labor pain.
A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35. All patients will be sitting to receive their epidural analgesia for labor pain.
A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1, L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (C) | – | Device: Color Dopplerpatients with BMI less than 35 |
| Group (O) | – | Device: Color Dopplerpatients with BMI more than 35 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- labouring pregnant women aged 18-45 years with a singleton gestation requesting epidural analgesia.
Key inclusion criteria (1 listed)
- obstetric patients admitted for epidural analgesia in the labor department suite (LDS)
Key exclusion criteria (8 listed)
- Patients suffering from coagulopathy.
- Patients on recent anticoagulant therapy.
- Patients suffering from sepsis or with local sepsis at the insertion site.
- Patients with platelet count less than 100,000/dl.
- Patient refusal.
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 |
|---|---|---|
| Color DopplerAlso: Epidural cathetercolor Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter | Device | Group (C), Group (O) |
Primary outcome
sensitivity
Time frame: 30 min
Number and percentage of patients in both groups where the flow was detected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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?
An observational study of Labor Pain, 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 8 May 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sensitivity (time frame: 30 min). 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 8 May 2026.