To Study the Safety and Efficacy of Disposable Cyclone Ring in Artificial Abortion

March 19, 2025 updated by: Peking Union Medical College Hospital
The purpose of this study is to compare the two surgical methods of surgical rotation abortion and surgical negative pressure uterine aspiration with the termination of pregnancy. which one can better protect female fertility; To understand the impact of both surgical approaches on the long-term prognosis of patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: xinyan Liu Liuxinyan
  • Phone Number: +86 186 0000 8013
  • Email: liuxymeng@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking Union Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) Age: 20-40 years old, planning to terminate pregnancy; 2) Menopause time≤ 56 days (8 weeks); 3) Ultrasound examination showed early pregnancy in utero, and the average diameter of the fetal sac was 1-3cm; 4) According to the requirements of clinical operation standards, the preoperative examination, laboratory results and surgical indicators are normal 5) The subject was conscious, had good compliance, agreed to participate in the trial, and voluntarily signed the informed consent form

Exclusion Criteria:

  • 1) According to the requirements of clinical practice, there are contraindications to induced abortion; 2) The number of previous induced abortions ≥2 times; 3) Diseases affecting uterine cavity morphology such as uterine malformations and uterine fibroids; 4) History of uterine surgery: such as submucosal myomectomy history, mediastinal resection history, uterine adhesion-separation history; 5) Unable to sign the informed consent; 6) Other conditions that the investigator considers inappropriate to participate in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotary induced abortion
Procedure: Rotary induced abortion
Rotary induced abortion under ultrasonic monitoring was performed with intravenous anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cervical dilation rate (e.g. %)
Time Frame: 30
30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

March 19, 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 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ChiCTR2400089857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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