Clinical Trial: Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective Randomized Study to Examine the Success Rate of External Cephalic Version for Breech Presentation at Term Presentation: Spinal Analgesia Versus No Analgesia

Brief Summary:

The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus.

Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful.

The main outcome is success of ECV.


Detailed Summary:

The rate of breech presentations in the general population of parturients has remained unchanged at 3%. However, the recent finding that the fetus has an increased morbidity during a vaginal delivery when compared with Cesarean section [1] has driven obstetricians towards the decision that all breech presentations will be delivered surgically. The morbidity of the mother with a breech presentation is not increased with a vaginal delivery; in fact the maternal morbidity associated with surgery is higher than after a vaginal delivery [2,3]. Subsequent pregnancies are automatically deemed high risk due to the presence of a uterine scar [4].

In an attempt to reduce the need for surgery with a breech presentation, the only option available in the current climate, where a vaginal delivery is out of the question, is to attempt to convert the fetal presentation from a breech to a vertex (head) presentation.

This technique may result in the premature onset of labor, which would require emergent surgery, and there is also a risk of placental abruption [5]. Following external cephalic version (ECV), the fetus may spontaneously return to the breech position. The success rates vary from 30% in nulliparous women, to 67% in multiparous women [6].

In an attempt to improve the success rates of ECV, authors have previously utilized regional anesthesia techniques [7-11]. Regional analgesia relaxes the stomach wall, and provides pain relief during the ECV procedure. The use of regional analgesia has claimed to increase the success rate of ECV to up to 80% [7]. However, other studies found no differences in success rates between the group which received regional analgesia and the group that did not [12]. All of these studies looked at women who have reached at least 36 weeks gestation. Despite
Sponsor: Hadassah Medical Organization

Current Primary Outcome: Conversion of a breech to a vertex presentation [ Time Frame: 4-6 years ]

Original Primary Outcome: Conversion of a breech to a vertex presentation

Current Secondary Outcome:

  • Complications associated with ECV: Premature rupture of membranes, Contractions, Placental abruption, Fetal distress, Pain score during procedure (VAS Scale 0 = no pain, 10 = severe pain). [ Time Frame: 4-6 years ]
  • Complications associated with analgesia: Severe maternal hypotension (>20 reduction in systolic BP), Fetal distress (prior to performance of ECV), Post Dural Puncture Headache, Failure of analgesia. [ Time Frame: 4-6 years ]
  • Inability to perform procedure due to maternal distress or discomfort. [ Time Frame: 4-6 years ]
  • Mode of delivery and date from the ECV. [ Time Frame: 4-6 years ]


Original Secondary Outcome:

  • Complications associated with ECV: Premature rupture of membranes, Contractions, Placental abruption, Fetal distress, Pain score during procedure (VAS Scale 0 = no pain, 10 = severe pain).
  • Complications associated with analgesia: Severe maternal hypotension (>20 reduction in systolic BP), Fetal distress (prior to performance of ECV), Post Dural Puncture Headache, Failure of analgesia.
  • Inability to perform procedure due to maternal distress or discomfort.
  • Mode of delivery and date from the ECV.


Information By: Hadassah Medical Organization

Dates:
Date Received: July 3, 2005
Date Started: October 2002
Date Completion:
Last Updated: June 5, 2008
Last Verified: May 2008