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临床试验/NCT06867133
NCT06867133尚未招募不适用

The Evaluation of the Curative Effect of Electrophysiological Rehabilitation Services on Endometrial Repair After Induced Abortion

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
试验地点
1
主要终点
Transvaginal ultrasound examination is used to measure the thickness of the endometrium.

研究概览

简要总结

Exploring the efficacy evaluation of electrophysiological rehabilitation services in endometrial repair after induced abortion, providing scientific basis for medical institutions and government post abortion care decision-making.

This study is a multicenter randomized controlled intervention study. The main endpoint of the study was the measurement of endometrial thickness by transvaginal ultrasound on days 21-23 after abortion.

Secondary study endpoint:

  1. Postoperative uterine contraction pain;
  2. Patient satisfaction;
  3. Menstrual recurrence time;
  4. Changes in menstrual flow for two consecutive periods after surgery;
  5. The duration of two consecutive menstrual periods after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female aged 18-40 years old;
  • •Previous menstrual patterns;
  • •Pregnancy duration 6-10 weeks;
  • •Ultrasound indicates intrauterine pregnancy;
  • •Voluntarily accepting surgical induced abortion with no contraindications for induced abortion;
  • •Voluntarily participate in the trial and sign the informed consent form.
  • •Patients or their families are able to understand the research protocol and are willing to participate in this study, providing written informed consent.

排除标准

  • •Medical abortion patients;
  • •Patients with pelvic and abdominal benign and malignant tumors and other systemic diseases; C) Skin problems such as ulceration, infection, and blisters at the treatment site;
  • •d) Patients with missed miscarriage diagnosed clinically; e) Patients with combined uterine fibroids, adenomyosis, and uterine malformations; f) Those who have inserted intrauterine devices (including copper containing intrauterine devices and levonorgestrel containing intrauterine devices); g) Individuals who have had three or more previous induced abortions; h) Clinical diagnosis of thin endometrium; i) Individuals with a history of cesarean section surgery; j) Individuals with severe mental illnesses; k) Researchers determine other situations that are not suitable for participating in this study; l) Patients or their families are unable to understand the conditions and objectives of this study.

研究组 & 干预措施

Electrophysiological Rehabilitation Group

Experimental

On the basis of treatment in the control group, postoperative electrophysiological rehabilitation services were started for 30 minutes each time, once a day, for 6 consecutive days as one course of treatment, for a total of one course of treatment. The patch is located at the projection site of the lower abdomen uterus as shown in the figure, simulating bioelectric stimulation parameters: biphasic pulse current, frequency 2Hz, pulse width 3ms.

Simultaneously conducting family health education, including but not limited to:

  1. Guidance on postoperative physical recovery after abortion: provide advice on postoperative care, nutrition, activity, and personal hygiene;
  2. Introduction to contraceptive methods: Introduce the advantages and disadvantages of various contraceptive methods, and help patients choose the most suitable contraceptive method for themselves;
  3. Other related health education: including fertility planning and the best time to conceive again.

干预措施: Electrophysiological rehabilitation (Device)

control group

No Intervention

Accept routine health education and follow-up after induced abortion surgery, excluding specialized home health education services and biomimetic electrical stimulation therapy. Pay attention to postoperative recovery, usually through telephone or outpatient follow-up, and receive routine anti infective treatment after surgery.

结局指标

主要结局

Transvaginal ultrasound examination is used to measure the thickness of the endometrium.

时间窗: On the 21st to 23rd day after abortion.

On the 21st to 23rd day after abortion, vaginal ultrasound was used to measure endometrial thickness.

次要结局

  • Postoperative uterine contraction pain(One week after surgery)
  • Patient satisfaction(3 months after surgery)
  • Menstrual recurrence time(3 months after surgery)
  • Changes in menstrual flow for two consecutive periods after surgery(3 months after surgery)
  • Duration of two consecutive menstrual periods after surgery(3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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