Collaris R, Tan P C
Department of Obstetrics and Gynaecology, University of Malaya, Kuala Lumpur, Malaysia.
BJOG. 2009 Jan;116(1):74-80; discussion 80-1. doi: 10.1111/j.1471-0528.2008.01991.x.
To evaluate oral nifedipine versus subcutaneous terbutaline tocolysis for external cephalic version (ECV).
A double-blind randomised trial.
A university hospital in Malaysia.
Non-labouring women with a term singleton fetus in breech presentation or transverse lie suitable for elective ECV.
Participants were randomised to either 10 mg oral nifedipine tablet and subcutaneous saline placebo or oral placebo tablet and 250 microgram bolus terbutaline subcutaneously. Participants and providers were blinded. Ultrasound assessment and cardiotocogram were performed prior to ECV. ECV was commenced 20-30 minutes after treatment. A maximum of two ECV attempts were permitted. Elective caesarean delivery or a repeat ECV attempt at a later date was offered to participants following failed ECV. After successful ECV, management was expectant.
Primary outcomes were successful ECV (cephalic presentation immediately after ECV) and caesarean delivery.
Ninety women were randomised: 44 to nifedipine and 46 to terbutaline. Initial ECV success rate was 15/44 (34.1%) versus 24/46 (52.2%) (relative risk [RR] 0.7, 95% CI 0.4-1.1; P= 0.094), and caesarean delivery rate was 34/44 (77.3%) versus 26/46 (56.5%) (RR 1.4, 95% CI 1.01-1.85; numbers needed to treat to benefit 5, 95% CI 2.5-55; P= 0.046) for nifedipine and terbutaline groups, respectively. Neonatal outcome was not different.
Bolus subcutaneous terbutaline tocolysis for ECV compared with oral nifedipine resulted in less caesarean deliveries. ECV success rate was not significantly higher. Larger studies are indicated.
评估口服硝苯地平与皮下注射特布他林用于外倒转术（ECV）的效果。
双盲随机试验。
马来西亚的一家大学医院。
足月单胎臀位或横位、适合择期外倒转术的未临产妇女。
参与者被随机分为两组，一组口服10毫克硝苯地平片并皮下注射生理盐水安慰剂，另一组口服安慰剂片并皮下注射250微克特布他林推注剂。参与者和医护人员均不知情。在进行外倒转术之前进行超声评估和胎心监护。治疗后20 - 30分钟开始外倒转术。最多允许进行两次外倒转术尝试。外倒转术失败后，为参与者提供择期剖宫产或日后再次进行外倒转术的选择。外倒转术成功后，采取期待治疗。
主要结局为外倒转术成功（外倒转术后即刻为头位）和剖宫产。
90名女性被随机分组：44名接受硝苯地平治疗，46名接受特布他林治疗。初始外倒转术成功率分别为15/44（34.1%）和24/46（52.2%）（相对危险度[RR] 0.7，95%置信区间0.4 - 1.1；P = 0.094），硝苯地平组和特布他林组的剖宫产率分别为34/44（77.3%）和26/46（56.5%）（RR 1.4，95%置信区间1.01 - 1.85；需治疗人数以获益为5，95%置信区间2.5 - 55；P = 0.046）。新生儿结局无差异。
与口服硝苯地平相比，皮下注射特布他林推注剂用于外倒转术可减少剖宫产率。外倒转术成功率无显著提高。需要开展更大规模的研究。
