Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
NCT Number: NCT06867133
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.
Trial opening soon.
Get Notified18 year–40 year
Female
Interventional
Not applicable
Beijing, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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:
Time frame: On the 21st to 23rd day after abortion.
On the 21st to 23rd day after abortion, vaginal ultrasound was used to measure endometrial thickness.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Peking Union Medical College Hospital
Other
Acronym: rehabilitation
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