Clinical trial NCT06867133: The Evaluation of the Curative Effect of Electrophysiological Rehabilitation Services on Endometrial Repair After Induced Abortion
Official title: The Evaluation of the Curative Effect of Electrophysiological Rehabilitation Services on Endometrial Repair After Induced Abortion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrium
Keywords: endometrium
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Transvaginal ultrasound examination is used to measure the thickness of the endometrium.
timeFrame: On the 21st to 23rd day after abortion.
Secondary outcomes:
measure: Postoperative uterine contraction pain
timeFrame: One week after surgery
measure: Patient satisfaction
timeFrame: 3 months after surgery
measure: Menstrual recurrence time
timeFrame: 3 months after surgery
measure: Changes in menstrual flow for two consecutive periods after surgery
timeFrame: 3 months after surgery
measure: Duration of two consecutive menstrual periods after surgery
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study officials:
References: