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The best time and safety evaluation of Shupeng disposable cervical dilatation rod for cervical dilatation before gynecological uterine cavity operation

The best time and safety evaluation of Shupeng disposable cervical dilatation rod for cervical dilatation before gynecological uterine cavity operation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098216
Enrollment
Unknown
Registered
2025-03-04
Start date
2024-08-02
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial polyps,Uterine submucous myoma,Uterine cavity residual pregnancy tissue,Artificial abortion,Intrauterine device removal

Interventions

A Group:The expansion rod was taken out after placing in the cervix for 1 minute.
B Group:The expansion rod was taken out after placing in the cervix for 3 minute.
C Group:The expansion rod was taken out after placing in the cervix for 5 minute.

Sponsors

Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.women aged 18 years or older; 2.Those who voluntarily accepted intrauterine operations such as ring removal, curettage, artificial abortion, hysteroscopy, and signed informed consent in writing; 3.There was no known allergic reaction or sensitivity of normal saline and polyvinyl alcohol formaldehyde polymer materials in the past;

Exclusion criteria

Exclusion criteria: 1.There are known abnormalities in the development of uterine cavity structure or compression of lesions such as uterine fibroids, which lead to uterine cavity deformation. 2.Congenital cervical abnormalities; 3.Previous history of cervical surgery; 4.Postmenopausal cervical extreme atrophy, structure disappeared; 5.The use of drugs that may soften the cervix, such as misoprostol, phloroglucinol injection, etc. and is in the drug effect period; 6.Foly catheter, seaweed rod and other tools for cervical dilatation have been used. 7.Cervical biopsy was performed before uterine cavity operation; 8.Untreated acute cervicitis or pelvic inflammatory disease; 9.Can 't understand how to score pain by visual analogue scale ( VAS ). 10.Not willing to participate in this study;

Design outcomes

Primary

MeasureTime frame
Cervical dilatation before the use of cervical dilatation rod;Cervical dilatation after the use of cervical dilatation rod;

Secondary

MeasureTime frame
Time required for mechanical expansion ( T );pain score;Surgeons evaluated the use of disposable cervical dilatation sticks ( 5-point Likert scale ).;Adverse events, patient satisfaction with pain control, and intraoperative complications occurred.;

Countries

China

Contacts

Public ContactJinyi Tong

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

tongjinyi252@zju.edu.cn+86 571 5600 5077

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026