ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube

Early Pregnancy Clinical Trial

Official title:

ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02847910
• Other study ID #: 2014KTCC 03-05
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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．

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The First Affliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (3)

Albers CE, Steppacher SD, Ganz R, Siebenrock KA, Tannast M. Joint-preserving surgery improves pain, range of motion, and abductor strength after Legg-Calvé-Perthes disease. Clin Orthop Relat Res. 2012 Sep;470(9):2450-61. doi: 10.1007/s11999-012-2345-0. — View Citation

Juarez F, Singh S. Incidence of induced abortion by age and state, Mexico, 2009: new estimates using a modified methodology. Int Perspect Sex Reprod Health. 2012 Jun;38(2):58-67. doi: 10.1363/3805812. Erratum in: Int Perspect Sex Reprod Health. 2013 Mar;39(1):46. — View Citation

Vilela RC, Benchimol M. Trichomonas vaginalis and Tritrichomonas foetus: interaction with fibroblasts and muscle cells - new insights into parasite-mediated host cell cytotoxicity. Mem Inst Oswaldo Cruz. 2012 Sep;107(6):720-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	rate of leaving bed in 5 min by patient self (%)		5 min after the surgery
Secondary	operation time (minutes)	measure the operation time	up to 5-10 minutes until the operation finished
Secondary	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