Epidural Analgesia and Delivery of Second Twin

Analgesia Clinical Trial

— Epidural  

Official title:

Epidural Analgesia and Delivery of Second Twin: Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608006
• Other study ID #: IRB0000871247
• Secondary ID: Assiut Universit
• Status: Completed
• Start date: November 3, 2014
• Est. completion date: December 24, 2019

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 24, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Epidural
• Labor Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Abdelrady S Ibrahim, MD

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery of First twin	Vaginal or C-Section	24 hours
Primary	Delivery of Second twin	C-Section or C-Section	24 hours