ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube

August 19, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University
The purpose of this study is to explore the clinical effect of disposable tissue suction tube set for induced abortion and make comparison with traditional metal instruments．

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affliated Hospital of Xi'an Jiaotong University

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

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • premedical abortion diagnosed by ultrasound diagnosed
  • pregnancy for the first time
  • 7-9 weeks of pregnancy
  • voluntary termination of pregnancy
  • without surgical contraindication

Exclusion Criteria:

  • refuse this clinical trial
  • with systemic disease such as hypertensive disease, heart disease, diabetes
  • refuse to terminate the pregnancy

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: experimental group
device： High-tech disposable tissue suction set for uterine cavity tissue is produced by Xi'an Mejiajia Medical Equipment Company ; The participants will be use the disposable tissue suction set during the induced abortion procedure.
Procedure: the disposable tissue suction set
Induced abortion is a main backstop for terminating unwanted pregnancies, however, traditional hard metal instruments has lots of insufficiencies such as easily tissue damage, and repeatedly sterilization increases the incidence of cross infection in the hospital what leads to more complications of pelvic inflammation, infertility and so on. Therefore disposable non-metallic instruments are desperately needed as a way to decrease the complications and provide better medical services to patients. So, the investigators want to explore the clinical effect of disposable tissue suction tube set and make comparison with traditional metal instruments.
Experimental: control group
device： Traditional metal instruments for induced abortion procedure; The participants will be use traditional metal instruments during induced abortion procedure.
Procedure: traditional metal instruments of abortion
Induced abortion is a main backstop for terminating unwanted pregnancies. In Chinese hospital, traditional metal instruments are always used during the surgery. So the investigators want to explore the clinical effect of disposable tissue suction tube set and make comparison with traditional metal instruments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss (ml)
Time Frame: up to 5-10 minutes
It always takes 5-10 minutes to finish the induced abortion in the outpatient, so the investigators will measure the blood loss during the operation time.
up to 5-10 minutes
the rate of induced abortion syndrome (%);
Time Frame: up to 5-10 minutes
It always takes 5-10 minutes to finish the induced abortion in the outpatient, so the investigators will observe whether induced abortion syndrome happens to our patients during the operation time.
up to 5-10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate pain grade (0, I, II, III) by questionnaire
Time Frame: up to 5-10 minutes
The participants will be asked some questions on questionnaire about feeling to evaluate their pain grade.
up to 5-10 minutes
rate of leaving bed in 5 min by patient self (%)
Time Frame: 5 min after the surgery
5 min after the surgery
operation time (minutes)
Time Frame: up to 5-10 minutes until the operation finished
measure the operation time
up to 5-10 minutes until the operation finished
the success rate of induced abortion (%)
Time Frame: up to 15 days after the surgery
Ultrasound and gynecological examinations will be used to calculate the success rate of induced abortion.
up to 15 days after the surgery

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Qiling Li, MD, PHD, The First Affliated Hospital of Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 5, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014KTCC 03-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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