KCT0002855已完成未知
Efficacy and Safety of Hyaluronidase for Preventing Perineal Trauma during Vaginal Delivery in Nulliparous Women: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Soon Chun Hyang University Hospital Seoul0 个研究点目标入组 148 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 148
研究概览
简要总结
In this study, we compared the incidence of episiotomy, severe perineal trauma, and improvement of perineal edema between HAase injection and placebo groups. Despite a lower proportion of episiotomy and severe perineal laceration (third- and fourth-degree lacerations) in the HAase injection group compared with the placebo group (52.7% vs 62.0% and 5.1% vs 9.1%, respectively), there was no statistically significant difference. But the women receiving HAase injection had significantly improved perineal edema at 24 hours compared with those receiving placebo (p=0.01). No serious adverse events were noted in both groups.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 40(Year)（—）
- 性别
- Female
入选标准
- •1.Maternal age between 19 and 40 years old
- •2.Gestational age between 37 weeks 0 days and 41 weeks 6 days, nulliparous with no previous record of vaginal birth
- •3.Have never undergone surgery for the indication of cesarean section on the uterus and perineum
- •4.Singleton pregnancy
- •5.Do not have indications for emergency cesarean section during labor
- •6.Never been exposed to hepatitis during pregnancy (German measles, Chickenpox, hepatitis C, Syphilis, HIV)
- •7.Do not have uterine anomalies during antenatal consultation
- •8.Voluntary written consent to participate in the Clinical trial
排除标准
- •1.Multifetal gestations
- •2.Fetal congenital anomaly
- •3.Estimated birth weight over 4000 g
- •4.Diagnosed with gestational diabetes or gestational hypertension (pregnancy addiction) at antenatal consultation
- •5.Pregnant woman with family history of genetic disease
- •6. Alleged maternal underlying disease such as severe diabetes, hypertension, heart disease (congenital heart defects and venous congestion), epilepsy, kidney disease, autoimmune disease, active genital herpes infection, etc.
- •7.Breast cancer, uterine cancer, or genital malignancy, or suspected to have a previous history of malignancy within 5 years.
- •8.A serum protein level of less than 5.5 g / dl
- •9.Abnormal placental implantation
- •10.Hypersensitive conditions to hyaluronidase or bovine protein
- •11.RH (-) blood type pregnancy
- •12.the other tester judges that it is inappropriate for participation in the examination
研究者
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