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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Endometrium

Treatments: Device: Electrophysiological rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06867133

ChiCTR2400091098

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Medical abortion patients;
2. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Electrophysiological Rehabilitation Group

Experimental group

Description:

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.

Treatment:

Device: Electrophysiological rehabilitation

control group

No Intervention group

Description:

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.