ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube

Study Overview
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Brief Summary
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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．

Official Title
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ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube

Conditions
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Early Pregnancy

Intervention / Treatment
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* Procedure: the disposable tissue suction set
* Procedure: traditional metal instruments of abortion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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<br>* 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.<br>|
| Experimental: control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss (ml) | 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 (%); | 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 | 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 (%) |  | 5 min after the surgery | 
| operation time (minutes) | measure the operation time | up to 5-10 minutes until the operation finished | 
| the success rate of induced abortion (%) | Ultrasound and gynecological examinations will be used to calculate the success rate of induced abortion. | up to 15 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tissue suction tube, disposable instrument, induced abortion