Epidural Analgesia and Delivery of Second Twin (Epidural)

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Labor Pain; Epidural
• Intervention / Treatment: Drug: Bupivacaine-fentanyl

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 Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women with twins pregnancy planned for trial of vaginal delivery and gave birth

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaginal Delivery; Delivered both twins vaginally	Drug: 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; Other Names: Epidural Catheter insertion
C-Section Delivery; Delivered both twins by Cesarean Section	Drug: 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; Other Names: Epidural Catheter insertion
Vaginal/C-Section Delivery; Delivery first twin vaginally and second twin By C-Section.	Drug: 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; Other Names: Epidural Catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery of First twin	Vaginal or C-Section	24 hours
Delivery of Second twin	C-Section or C-Section	24 hours

Collaborators and Investigators

• Sponsor: Abdelrady S Ibrahim, MD
• Investigators: Principal Investigator: Abdelrady S Ibrahim, M.D., Assiut University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2014
• Primary Completion (Actual): December 24, 2019
• Study Completion (Actual): December 24, 2019

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia; Epidural; Labour
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: IRB0000871247; Ain Shams University (Registry Identifier: passant abdalla); Assiut Universitr (Other Identifier: Faculty of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No