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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometrium
• Intervention / Treatment: Device: Electrophysiological rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyan Liu， Ph.D; Phone Number: +86 186 0000 8013; Email: 4826645@qq.com

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Contact: Xinyan Liu， Ph.D; Phone Number: +86 186 0000 8013; Email: 4826645@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrophysiological Rehabilitation Group; 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: Guidance on postoperative physical recovery after abortion: provide advice on postoperative care, nutrition, activity, and personal hygiene;; Introduction to contraceptive methods: Introduce the advantages and disadvantages of various contraceptive methods, and help patients choose the most suitable contraceptive method for themselves;; Other related health education: including fertility planning and the best time to conceive again.	Device: Electrophysiological rehabilitation; 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: Guidance on postoperative physical recovery after abortion: provide advice on postoperative care, nutrition, activity, and personal hygiene;; Introduction to contraceptive methods: Introduce the advantages and disadvantages of various contraceptive methods, and help patients choose the most suitable contraceptive method for themselves;; Other related health education: including fertility planning and the best time to conceive again.
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative uterine contraction pain	The degree of postoperative pain was evaluated using the Visual Analogue Scale (VAS) scoring method. A horizontal line of 10 cm in length was drawn, with the two ends representing 0 and 10 respectively. 0 indicated no pain, and 10 represented the most unbearable pain that could be imagined. Patients were asked to select the corresponding number based on their postoperative pain sensation to describe the intensity of their subjective pain. The time for postoperative pain assessment was as follows: for the experimental group, the VAS pain score was evaluated before treatment on the second day after surgery and after one session of bioelectrical stimulation treatment; for the control group, the VAS pain score was evaluated only once on the second day after surgery.	One week after surgery
Patient satisfaction	Survey the satisfaction levels of patients in the control group and intervention group, specifically covering sub item satisfaction evaluations of biomimetic electrical stimulation treatment, doctor attitude, abortion process, and extended home rehabilitation services. Each item is divided into five levels: very satisfied, satisfied, average, dissatisfied, and very dissatisfied. In addition, the overall satisfaction of the above four items will be comprehensively evaluated.	3 months after surgery
Menstrual recurrence time	Observe the time of menstrual recurrence in two groups after surgery, that is, the interval between the completion of induced abortion and the recurrence of menstruation in the subjects.	3 months after surgery
Changes in menstrual flow for two consecutive periods after surgery	Understand the postoperative menstrual flow of the research subjects for two consecutive periods. The specific reference criteria are: compared with the preoperative menstrual flow, it is divided into five levels: much more, slightly more, similar, slightly less, and much less.	3 months after surgery
Duration of two consecutive menstrual periods after surgery	By conducting a 3-month online follow-up on the control group and intervention group, we aim to understand the duration of continuous menstruation in the study subjects after surgery.	3 months after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: endometrium
• Other Study ID Numbers: ChiCTR2400091098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No