NCT02847910

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．

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

June 5, 2016

Last Update Submit

August 19, 2021

Conditions

Early Pregnancy

Keywords

tissue suction tubedisposable instrumentinduced abortion

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • evaluate pain grade (0, I, II, III) by questionnaire

    up to 5-10 minutes

  • 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

  • the success rate of induced abortion (%)

    up to 15 days after the surgery

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

EXPERIMENTAL

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

Interventions

the disposable tissue suction setPROCEDURE

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 group
traditional metal instruments of abortionPROCEDURE

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.

control group

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (3)

  • 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.

    PMID: 22832146BACKGROUND

  • 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. doi: 10.1590/s0074-02762012000600003.

    PMID: 22990959BACKGROUND

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

    PMID: 22528379BACKGROUND

Study Officials

  • Qiling Li, MD, PHD

    The First Affliated Hospital of Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)