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

Not Applicable

Not yet recruiting

• Conditions: Endometrium

• Registration Number: NCT06867133
• Lead Sponsor: Peking Union Medical College Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-03-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transvaginal ultrasound examination is used to measure the thickness of the endometrium.	On the 21st to 23rd day after abortion.	On the 21st to 23rd day after abortion, vaginal ultrasound was used to measure endometrial thickness.

Secondary Outcome Measures

Name	Time	Method
Postoperative uterine contraction pain	One week after surgery	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.
Patient satisfaction	3 months after surgery	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.
Menstrual recurrence time	3 months after surgery	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.
Changes in menstrual flow for two consecutive periods after surgery	3 months 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.
Duration of two consecutive menstrual periods after surgery	3 months 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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China