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

NCT06867133 | Not Yet Recruiting

• 1 other identifier: ChiCTR2400091098
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrium

Keywords

endometrium

Outcome Measures

Primary Outcomes (1)

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

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

  On the 21st to 23rd day after abortion.

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

Device: Electrophysiological rehabilitation

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.

Interventions

Electrophysiological rehabilitation DEVICE

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.

Electrophysiological Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Central Study Contacts

Xinyan Liu， Ph.D

CONTACT

+86 186 0000 8013; 4826645@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 10, 2025
• Study Start: March 31, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)