EUCTR2017-004833-10-ES进行中（未招募）1 期
Clinical trial ramdomized for treatment of perineal pain and dyspareunia portpartum through local anesthetic infiltrations vs anesthetic and corticoids
Fundación para la Investigación Biomédica0 个研究点目标入组 248 人开始时间: 2017年12月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 248
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- 18 years-old or older. -Puerperas after instrumental delivery with episiotomy - Puerperas with prolonged expulsion> 3 hours with episiotomy - Puerperas with newborn> 4000 gr with episiotomy In addition, the patient must present perineal pain, at two months of delivery, with an intensity of at least 4 in the EVA scale.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 248
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Births <37 weeks. - Patients with allergies or contraindications to study drugs - Active vaginal infection - Neoplastic malignant processes. - Coagulation disorders due to bleeding risk after puncture. - Allergy to metals - Belonephobia (extreme fear, uncontrollable and irrational towards the needles) - Caesarean section - Knowledge of the Spanish language or inability to grant informed consent - Established pudendal neuropathy.
- •- Type 1 Diabetes Mellitus
研究者
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