Early PregnancyNCT02847910
ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube
A study testing the disposable tissue suction set and traditional metal instruments of abortion in people with Early Pregnancy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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． Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Early Pregnancy
- What is being tested?
- the disposable tissue suction set and traditional metal instruments of abortion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premedical abortion diagnosed by ultrasound diagnosed
- pregnancy for the first time
- 7-9 weeks of pregnancy
- voluntary termination of pregnancy
- without surgical contraindication
Who cannot join
- refuse this clinical trial
- with systemic disease such as hypertensive disease, heart disease, diabetes
- refuse to terminate the pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
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．
- Conditions
- Early Pregnancy
- Being tested
- the disposable tissue suction set, traditional metal instruments of abortion
- Keywords
- tissue suction tube, disposable instrument, induced abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the disposable tissue suction setProcedure or surgery
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 abortionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: traditional metal instruments of abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 5-10 minutes
Secondary outcomes (4)
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.
Measured: up to 5-10 minutes
rate of leaving bed in 5 min by patient self (%)
Measured: 5 min after the surgery
operation time (minutes)
measure the operation time
Measured: 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.
Measured: up to 15 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early PregnancyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiling Li, MD, PHD, Principal investigator, The First Affliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847910
- Sponsor's protocol ID
- 2014KTCC 03-05
- Status last verified
- Aug 2021
- First submitted
- 5 Jun 2016
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22832146Vilela 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.
PubMed 22990959Albers 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.
PubMed 22528379
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube
- ClinicalTrials.gov ID
- NCT02847910
- Acronym / sponsor ID
- 2014KTCC 03-05
- Conditions
- Early Pregnancy
- Keywords
- tissue suction tube, disposable instrument, induced abortion
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 500 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: the disposable tissue suction setdevice： 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 | Experimental | Procedure: traditional metal instruments of abortiondevice： Traditional metal instruments for induced abortion procedure; The participants will be use traditional metal instruments during induced abortion procedure. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- premedical abortion diagnosed by ultrasound diagnosed
- pregnancy for the first time
- 7-9 weeks of pregnancy
- voluntary termination of pregnancy
- without surgical contraindication
Key exclusion criteria (3 listed)
- refuse this clinical trial
- with systemic disease such as hypertensive disease, heart disease, diabetes
- refuse to terminate the pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the disposable tissue suction setInduced 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. | Procedure or surgery | experimental group |
| traditional metal instruments of abortionInduced 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. | Procedure or surgery | control group |
Primary outcome
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.
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.
4 secondary outcomes
evaluate pain grade (0, I, II, III) by questionnaire
Time frame: up to 5-10 minutes
rate of leaving bed in 5 min by patient self (%)
Time frame: 5 min after the surgery
operation time (minutes)
Time frame: up to 5-10 minutes until the operation finished
the success rate of induced abortion (%)
Time frame: up to 15 days after the surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 22832146Juarez 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.
- Background: PubMed 22990959Vilela 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.
- Background: PubMed 22528379Albers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiling Li, MD, PHD principal investigator
The First Affliated Hospital of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the disposable tissue suction set and traditional metal instruments of abortion in people with Early Pregnancy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (ml) (time frame: up to 5-10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847910, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.