Epidural Analgesia and Delivery of Second Twin

Sponsor

Abdelrady S Ibrahim, MD (Other)

Overall Status

Completed

CT.gov ID

NCT04608006

Collaborator

(none)

124

Enrollment

Location

61.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epidural Analgesia Labor Pain	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

124 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Epidural Analgesia and Delivery of Second Twin: Prospective Observational Study

Actual Study Start Date :

Nov 3, 2014

Actual Primary Completion Date :

Dec 24, 2019

Actual Study Completion Date :

Dec 24, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Delivery of First twin [24 hours]
Vaginal or C-Section
Delivery of Second twin [24 hours]
C-Section or C-Section

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.