ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube

Not Applicable

Terminated

• Conditions: Early Pregnancy
• Interventions: Procedure: the disposable tissue suction set; Procedure: traditional metal instruments of abortion

• Registration Number: NCT02847910
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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．

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-05
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	the disposable tissue suction set	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.
control group	traditional metal instruments of abortion	device： Traditional metal instruments for induced abortion procedure; The participants will be use traditional metal instruments during induced abortion procedure.

Primary Outcome Measures

Name	Time	Method
blood loss (ml)	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.
the rate of induced abortion syndrome (%);	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China