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Completed

NCT Number: NCT04608006

Epidural Analgesia and Delivery of Second Twin

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.

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Key information

Age range

16 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Epidural Catheter insertion

Primary outcomes

  1. Delivery of First twin

    Time frame: 24 hours

    Vaginal or C-Section

  2. Delivery of Second twin

    Time frame: 24 hours

    C-Section or C-Section

Sponsors and collaborators

Lead sponsor

Abdelrady S Ibrahim, MD

Other

Registry information

Official study title

Epidural Analgesia and Delivery of Second Twin: Prospective Observational Study

Acronym: Epidural

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2020
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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