Epidural Analgesia and Delivery of Second Twin

Completed

• Conditions: Epidural; Analgesia; Labor Pain
• Interventions: Drug: Bupivacaine-fentanyl

• Registration Number: NCT04608006
• Lead Sponsor: Abdelrady S Ibrahim, MD

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.

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 Timeline

• Study Start: 2014-11-03
• Primary Completion: 2019-12-24
• Study Completion: 2019-12-24
• Status Verified: 2020-10
• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-29
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaginal Delivery	Bupivacaine-fentanyl	Delivered both twins vaginally
C-Section Delivery	Bupivacaine-fentanyl	Delivered both twins by Cesarean Section
Vaginal/C-Section Delivery	Bupivacaine-fentanyl	Delivery first twin vaginally and second twin By C-Section.

Primary Outcome Measures

Name	Time	Method
Delivery of First twin	24 hours	Vaginal or C-Section
Delivery of Second twin	24 hours	C-Section or C-Section

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt