Epidural Analgesia and Delivery of Second Twin

NCT04608006 | Completed DMC FDA Drug

• 3 other identifiers: IRB0000871247Assiut UniversitrAin Shams University
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Epidural; Analgesia; Labor Pain

Keywords

Epidural; Analgesia; Labour

Outcome Measures

Primary Outcomes (2)

• Delivery of First twin

  Vaginal or C-Section

  24 hours

• Delivery of Second twin

  C-Section or C-Section

  24 hours

Study Arms (3)

Vaginal Delivery

Delivered both twins vaginally

Drug: Bupivacaine-fentanyl

C-Section Delivery

Delivered both twins by Cesarean Section

Drug: Bupivacaine-fentanyl

Vaginal/C-Section Delivery

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

Drug: Bupivacaine-fentanyl

Interventions

Bupivacaine-fentanyl 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

Also known as: Epidural Catheter insertion

C-Section Delivery; Vaginal Delivery; Vaginal/C-Section Delivery

Eligibility Criteria

• Age: 16 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abdelrady S Ibrahim, MD: lead

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related Publications (1)

• 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.

  PMID: 12100802 BACKGROUND

MeSH Terms

Conditions

Agnosia; Labor Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Abdelrady S Ibrahim, M.D.

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assiut University Faculty of Medicine Anesthesia Dept

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: November 3, 2014
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

EG (1)