A Prospective Randomized Study to Examine the Success Rate of External Cephalic Version for Breech Presentation at Term Presentation: Spinal Analgesia Versus No Analgesia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Conversion of a breech to a vertex presentation
研究概览
简要总结
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.
详细描述
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 the well-recognized differences in success rates between nulliparous and multiparous women, none of the studies that have examined regional analgesia with ECV have controlled for this factor in their studies. Thus the success rates, and any increase in success rates that is seen, may purely be a function of the number of multiparous women enrolled in the study.
This study will compare ECV separately in both a nulliparous and multiparous population, at term, and compare the success rates when spinal anesthesia is employed, versus no anesthesia. Success is defined as the conversion of a breech to vertex presentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •37 + weeks gestation
- •No previous attempt at ECV in this pregnancy
- •No fetal abnormality
排除标准
- •No previous uterine surgery
- •Any contraindication for vaginal delivery
- •Contra-indications to regional analgesia: uncorrected hypovolemia, coagulopathy (including anti-coagulants but not low-dose [100mg] aspirin), infection or inflammation of the skin overlying the lumbar area, raised intra-cranial pressure, hypersensitivity to amide local anesthetic agents.
- •Patient refusal for regional analgesia
- •Previous history of meningitis, neuropathy, or severe back pain with neurological radiation
- •Poor communication (no Hebrew or English spoken, deafness, blindness, serious intellectual impairment or psychiatric disorder)
- •Morbid obesity
研究组 & 干预措施
External cephalic version with spinal anesthesia
External cephalic version with spinal anesthesia
干预措施: External cephalic version (Procedure)
External cephalic version with spinal anesthesia
External cephalic version with spinal anesthesia
干预措施: spinal anesthesia (Drug)
External cephalic version without spinal anesthesia
External cephalic version without spinal anesthesia
干预措施: External cephalic version (Procedure)
结局指标
主要结局
Conversion of a breech to a vertex presentation
时间窗: 4-6 years
次要结局
- Mode of delivery and date from the ECV.(4-6 years)
- Inability to perform procedure due to maternal distress or discomfort.(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.(4-6 years)
- 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).(4-6 years)
