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过期妊娠引产与期待治疗的临床试验。美国国立儿童健康与人类发展研究所母胎医学单位网络。

A clinical trial of induction of labor versus expectant management in postterm pregnancy. The National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units.

出版信息

Am J Obstet Gynecol. 1994 Mar;170(3):716-23.

PMID:7710467
Abstract

OBJECTIVE

Management of the uncomplicated pregnancy prolonged beyond the estimated date of confinement is controversial, particularly when the cervix is unfavorable for induction. The benefit of reducing potential fetal risk with induction of labor must be balanced against the morbidity associated with this procedure. The objective of this study was to compare two strategies for managing postterm pregnancy (i.e., immediate induction and expectant management).

STUDY DESIGN

Four hundred forty patients with uncomplicated pregnancies at 41 weeks' gestation were randomized to either immediate induction of labor (n = 265) or expectant management (n = 175). Patients with expectant management underwent nonstress testing and amniotic fluid volume assessment twice per week. Patients in the induction group underwent induction within 24 hours of randomization. To evaluate the efficacy of intracervical prostaglandin E2 gel, patients in the induction group were randomized in a 2:1 scheme to receive either 0.5 mg prostaglandin E2 gel or placebo gel intracervically 12 hours before induction of labor with oxytocin.

RESULTS

The incidence of adverse perinatal outcome (neonatal seizures, intracranial hemorrhage, the need for mechanical ventilation, or nerve injury) was 1.5% in the induction group and 1% in the expectant management group (p > 0.05). There were no fetal deaths in either group. There were no differences in mean birth weight or the frequency of macrosomia (birth weight > or = 4000 gm) between the two groups (p > 0.05). Regardless of parity, prostaglandin E2 intracervical gel was not more effective than placebo in ripening the cervix. The cesarean delivery rate was not significantly different in the expectant (18%), prostaglandin E2 gel (23%), or placebo gel (18%) groups.

CONCLUSIONS

Adverse perinatal outcome in otherwise uncomplicated pregnancies of > or = 41 weeks is very low with either of the management schemes described. Thus from the perspective of perinatal morbidity or mortality either management scheme is acceptable.

摘要

目的

对于超过预产期仍无并发症的妊娠的管理存在争议,尤其是当宫颈条件不利于引产时。引产降低潜在胎儿风险的益处必须与该操作相关的发病率相权衡。本研究的目的是比较两种管理过期妊娠的策略(即立即引产和期待管理)。

研究设计

440例妊娠41周无并发症的患者被随机分为立即引产组(n = 265)或期待管理组(n = 175)。期待管理组的患者每周进行两次无应激试验和羊水容量评估。引产组的患者在随机分组后24小时内进行引产。为了评估宫颈内前列腺素E2凝胶的疗效,引产组的患者按2:1的方案随机分组,在使用缩宫素引产12小时前宫颈内给予0.5 mg前列腺素E2凝胶或安慰剂凝胶。

结果

引产组围产期不良结局(新生儿惊厥、颅内出血、机械通气需求或神经损伤)的发生率为1.5%,期待管理组为1%(p>0.05)。两组均无胎儿死亡。两组之间的平均出生体重或巨大儿(出生体重≥4000 g)的频率无差异(p>0.05)。无论产次如何,宫颈内前列腺素E2凝胶在宫颈成熟方面并不比安慰剂更有效。期待管理组(18%)、前列腺素E2凝胶组(23%)或安慰剂凝胶组(18%)的剖宫产率无显著差异。

结论

对于妊娠≥41周且无其他并发症的情况,上述两种管理方案的围产期不良结局都非常低。因此,从围产期发病率或死亡率的角度来看,两种管理方案都是可以接受的。

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