EpiduralEpiduralNCT04608006
Epidural Analgesia and Delivery of Second Twin
An observational study of Epidural and Analgesia, run by Abdelrady S Ibrahim, MD at 1 site in Egypt.
Trial summary
Over an 8-year period, 124 twin pregnancies at gestational age ≥32 weeks with both twins presenting as a vertex and eligible for vaginal delivery were reviewed. Excluded were patients with the following intrapartum factors which may affect mode of delivery of second twin: 1. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural, Analgesia, Labor Pain
- What is being tested?
- Bupivacaine-fentanyl
- Type of treatment
- Injection or infusion
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2014to 24 Dec 2019
- How long will I take part?
- 5 Years
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women with twins pregnancy planned for trial of vaginal delivery and gave birth
Who may be able to join
- .gestational age of 32 weeks, determined by an early ultrasound performed in the second trimester or certain last menstrual period; (2) both twins viable; (3) eligibility for vaginal delivery as defined by twin A being cephalic; and (4) no previous cesarean section.
Who cannot join
- underwent an elective or repeat cesarean section
- presentation of twin B at delivery other than cephalic (breech, oblique or transverse presentation
- induction of labour
- the difference in foetal weight between twin B and twin A at delivery ≥25% .Neonates were excluded if one was stillborn or had major congenital malformations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Analgesia and Delivery of Second Twin: Prospective Observational Study
Over an 8-year period, 124 twin pregnancies at gestational age ≥32 weeks with both twins presenting as a vertex and eligible for vaginal delivery were reviewed. Excluded were patients with the following intrapartum factors which may affect mode of delivery of second twin: 1. Presentation of the 2nd twin: breech or other than vertex; 2. Monochorionic twins; 3. Induction of labour; 4. difference in foetal weight between twin B and twin A ≥25%. The chi-square statistic was used to compare differences in the incidence of retained second twin between the groups.
Read the detailed description
The investigators conducted this prospective study in women with twins pregnancy planned for trial of vaginal delivery and gave birth between January 2014 and December 2019, in the Department of obstetrics and Gynaecology of the Sabah Maternity Hospital, Sabah Specialized Area, Kuwait. The Sabah Maternity Hospital is a tertiary care hospital for the country of Kuwait with approximately 12500 deliveries per year. The study protocol was approved by the Ethics Committee.
- Conditions
- Epidural, Analgesia, Labor Pain
- Being tested
- Bupivacaine-fentanyl
- Keywords
- Epidural, Analgesia, Labour
- Medical subject headings
- Agnosia, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-fentanylDrug
Also called Epidural Catheter insertion
Initial epidural bolus of 10 ml Bupivacaine 0.125% plus 50 mcg Fentanyl, followed by continuous infusion pf Bupivacaine 0.0625%™ plus 1mcg/dl Fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Delivery | Delivered both twins vaginally Receives: Drug: Bupivacaine-fentanyl | |
| C-Section Delivery | Delivered both twins by Cesarean Section Receives: Drug: Bupivacaine-fentanyl | |
| Vaginal/C-Section Delivery | Delivery first twin vaginally and second twin By C-Section. Receives: Drug: Bupivacaine-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of First twin
Vaginal or C-Section
Measured: 24 hours
Delivery of Second twin
C-Section or C-Section
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start3 Nov 2014
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpiduralStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Abdelrady S Ibrahim, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Abdelrady S Ibrahim, M.D., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608006
- Sponsor's protocol ID
- IRB0000871247
- Other IDs
- Assiut Universitr, Ain Shams University
- Acronym
- Epidural
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alexander JM, Sharma SK, McIntire DD, Leveno KJ. Epidural analgesia lengthens the Friedman active phase of labor. Obstet Gynecol. 2002 Jul;100(1):46-50. doi: 10.1016/s0029-7844(02)02009-4.
PubMed 12100802
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Analgesia and Delivery of Second Twin: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04608006
- Acronym / sponsor ID
- Epidural / IRB0000871247
- Conditions
- Epidural, Analgesia, Labor Pain
- Keywords
- Epidural, Analgesia, Labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Abdelrady S Ibrahim, MDUniversity, hospital or other
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 29 Oct 2020 (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.
Over an 8-year period, 124 twin pregnancies at gestational age ≥32 weeks with both twins presenting as a vertex and eligible for vaginal delivery were reviewed. Excluded were patients with the following intrapartum factors which may affect mode of delivery of second twin: 1. Presentation of the 2nd twin: breech or other than vertex; 2. Monochorionic twins; 3. Induction of labour; 4. difference in foetal weight between twin B and twin A ≥25%. The chi-square statistic was used to compare differences in the incidence of retained second twin between the groups.
Detailed description
The investigators conducted this prospective study in women with twins pregnancy planned for trial of vaginal delivery and gave birth between January 2014 and December 2019, in the Department of obstetrics and Gynaecology of the Sabah Maternity Hospital, Sabah Specialized Area, Kuwait. The Sabah Maternity Hospital is a tertiary care hospital for the country of Kuwait with approximately 12500 deliveries per year. The study protocol was approved by the Ethics Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginal Delivery | – | Drug: Bupivacaine-fentanylDelivered both twins vaginally |
| C-Section Delivery | – | Drug: Bupivacaine-fentanylDelivered both twins by Cesarean Section |
| Vaginal/C-Section Delivery | – | Drug: Bupivacaine-fentanylDelivery first twin vaginally and second twin By C-Section. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women with twins pregnancy planned for trial of vaginal delivery and gave birth
Key inclusion criteria (1 listed)
- .gestational age of 32 weeks, determined by an early ultrasound performed in the second trimester or certain last menstrual period; (2) both twins viable; (3) eligibility for vaginal delivery as defined by twin A being cephalic; and (4) no previous cesarean section.
Key exclusion criteria (4 listed)
- underwent an elective or repeat cesarean section
- presentation of twin B at delivery other than cephalic (breech, oblique or transverse presentation
- induction of labour
- the difference in foetal weight between twin B and twin A at delivery ≥25% .Neonates were excluded if one was stillborn or had major congenital malformations.
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 |
|---|---|---|
| Bupivacaine-fentanylAlso: Epidural Catheter insertionInitial epidural bolus of 10 ml Bupivacaine 0.125% plus 50 mcg Fentanyl, followed by continuous infusion pf Bupivacaine 0.0625%™ plus 1mcg/dl Fentanyl | Drug | C-Section Delivery, Vaginal Delivery, Vaginal/C-Section Delivery |
Primary outcome
Delivery of First twin
Time frame: 24 hours
Vaginal or C-Section
Delivery of Second twin
Time frame: 24 hours
C-Section or C-Section
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 30 Oct 2020.
- Background: PubMed 12100802Alexander JM, Sharma SK, McIntire DD, Leveno KJ. Epidural analgesia lengthens the Friedman active phase of labor. Obstet Gynecol. 2002 Jul;100(1):46-50. doi: 10.1016/s0029-7844(02)02009-4.
- Individual participant dataSharing planned: Undecided
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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.
Abdelrady S Ibrahim, M.D. principal investigator
Assiut University
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 Epidural and Analgesia, run by Abdelrady S Ibrahim, MD 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 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: finished, as of the sponsor's last update on 30 Oct 2020. 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?
Delivery of First twin (time frame: 24 hours). 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?
On the ClinicalTrials.gov record for NCT04608006, which also lists 1 linked publication.
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 30 Oct 2020.