Morbid ObesityNCT04963452
Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
A study testing Dural puncture epidural in people with Morbid Obesity, run by Ain Shams University at 1 site in Egypt.
Trial summary
Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor analgesia. The DPE technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Dural puncture epidural
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2021to 9 May 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 45 years old,
- Physical status American society of anesthesiology (ASA) II,
- Singleton,
- Vertex fetuses at 37-41 weeks' gestation,
- Nulliparous and multiparous women,
- Immediately before epidural placement, subjects marked a VNRS score during an active contraction and parturients with VNRS ≥ 50 were included
- Cervical dilatation < 5 cm
Who cannot join
- Contraindications to regional anesthesia
- Refuse to participate
- No pain
- Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
- Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery) and vaginal birth after cesarean delivery
Trial locations and contacts
1 site in 1 country.
About this study
Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor analgesia. The DPE technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural technique without the side effects observed with the CSE technique.
Read the detailed description
Investigators designed this prospective interventional study to determine if morbid obesity would influence DPE technique regarding labor analgesia onset and block characteristics.
- Conditions
- Morbid Obesity
- Being tested
- Dural puncture epidural
- Keywords
- Morbid Obesity, Labor Pain
- Medical subject headings
- Obesity, Morbid, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural puncture epiduralOther
Parturients, between 18 and 45 years of age, with cervical dilation less than 5 cm were consented to receive a DPE technique, with a single dural puncture with a 26-gauge spinal needle. After successful placement of the epidural catheter and puncturing the dura; 20 mL of bupivacaine 0.25% was administered through the epidural catheter and a patient-controlled epidural infusion of bupivacaine was initiated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Normal weight BMI 20-24.9 kg/m2 Receives: Other: Dural puncture epidural |
| Group 2 | Active comparator | Morbid Obese BMI : 40-49.9 kg/m2 Receives: Other: Dural puncture epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adequate analgesia
The primary outcome of this study is the incidence of patients having adequate analgesia (VNRS <30) at 5 minutes of epidural activation
Measured: 5 minutes
Secondary outcomes (3)
Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )
Verbal numerical pain score (VNRS) (pain) was recorded before epidural (0 min baseline), at 5 min, 10 min, 15 min and then every 15 min till 1 hour and then every 30 min till delivery.
Measured: 6 hours
Sensory level of DPE by pricking by blunt head of a pin
- Was recorded before epidural (0 min-baseline), at 5 min, 10 min, 15 min and then every 15 min till 1 hour and then every 30 min till delivery.
- Sensory level of DPE was assessed by loss of sensation to prick by blunt head of a pin.
Measured: 6 hours
Motor block Bromage score (1 being complete motor block and 6 being no motor block)
- Motor strength was assessed with a modified Bromage score
- Was recorded before epidural (0 min baseline), at 5 min, 10 min, 15 min and then every 15 min till 1 hour and then every 30 min till delivery.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start29 Aug 2021
- Primary completion15 Apr 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raham Hasan Mostafa, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963452
- Sponsor's protocol ID
- R 149/2021
- Status last verified
- May 2022
- First submitted
- 6 Jul 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
- ClinicalTrials.gov ID
- NCT04963452
- Acronym / sponsor ID
- R 149/2021
- Conditions
- Morbid Obesity
- Keywords
- Morbid Obesity, Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 Aug 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 15 Jul 2021 (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.
Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor analgesia. The DPE technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural technique without the side effects observed with the CSE technique.
Detailed description
Investigators designed this prospective interventional study to determine if morbid obesity would influence DPE technique regarding labor analgesia onset and block characteristics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Other: Dural puncture epiduralNormal weight BMI 20-24.9 kg/m2 |
| Group 2 | Active comparator | Other: Dural puncture epiduralMorbid Obese BMI : 40-49.9 kg/m2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 - 45 years old,
- Physical status American society of anesthesiology (ASA) II,
- Singleton,
- Vertex fetuses at 37-41 weeks' gestation,
- Nulliparous and multiparous women,
Key exclusion criteria (5 listed)
- Contraindications to regional anesthesia
- Refuse to participate
- No pain
- Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
- Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery) and vaginal birth after cesarean delivery
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 |
|---|---|---|
| Dural puncture epiduralParturients, between 18 and 45 years of age, with cervical dilation less than 5 cm were consented to receive a DPE technique, with a single dural puncture with a 26-gauge spinal needle. After successful placement of the epidural catheter and puncturing the dura; 20 mL of bupivacaine 0.25% was administered through the epidural catheter and a patient-controlled epidural infusion of bupivacaine was initiated. | Other | Group 1, Group 2 |
Primary outcome
Incidence of adequate analgesia
Time frame: 5 minutes
The primary outcome of this study is the incidence of patients having adequate analgesia (VNRS <30) at 5 minutes of epidural activation
3 secondary outcomes
Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )
Time frame: 6 hours
Sensory level of DPE by pricking by blunt head of a pin
Time frame: 6 hours
Motor block Bromage score (1 being complete motor block and 6 being no motor block)
Time frame: 6 hours
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 11 May 2022.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Dural puncture epidural in people with Morbid Obesity, run by Ain Shams 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 7 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: finished, as of the sponsor's last update on 11 May 2022. 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.
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?
Incidence of adequate analgesia (time frame: 5 minutes). 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 11 May 2022.