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Epidural Analgesia and Delivery of Second Twin

NCT ID: NCT04608006

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-03

Study Completion Date

2019-12-24

Brief Summary

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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

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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

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Epidural Analgesia Labor Pain

Keywords

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Epidural Analgesia Labour

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaginal Delivery

Delivered both twins vaginally

Bupivacaine-fentanyl

Intervention Type DRUG

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

C-Section Delivery

Delivered both twins by Cesarean Section

Bupivacaine-fentanyl

Intervention Type DRUG

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

Vaginal/C-Section Delivery

Delivery first twin vaginally and second twin By C-Section.

Bupivacaine-fentanyl

Intervention Type DRUG

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

Interventions

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Bupivacaine-fentanyl

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

Intervention Type DRUG

Other Intervention Names

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Epidural Catheter insertion

Eligibility Criteria

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Inclusion Criteria

.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.

Exclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abdelrady S Ibrahim, MD

OTHER

Sponsor Role lead

Responsible Party

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Abdelrady S Ibrahim, MD

Assiut University Faculty of Medicine Anesthesia Dept

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abdelrady S Ibrahim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut university faculty of medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 12100802 (View on PubMed)

Other Identifiers

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Assiut Universitr

Identifier Type: OTHER

Identifier Source: secondary_id

Ain Shams University

Identifier Type: OTHER

Identifier Source: secondary_id

IRB0000871247

Identifier Type: -

Identifier Source: org_study_id