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The effectiveness and safety of Carboprost Methylate (methyl carprost suppository) in cervix pretreatment before hysteroscopic diagnosis: A randomized, double-blind, placebo-controlled clinical study.

The effectiveness and safety of Carboprost Methylate (methyl carprost suppository) in cervix pretreatment before hysteroscopic diagnosis: A randomized, double-blind, placebo-controlled clinical study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004590
Enrollment
Unknown
Registered
2014-04-01
Start date
2014-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

uterine disease

Interventions

Methyl carprost suppository group:1 hour pre operatively vaginal vault placed Carprost 0.5mg
Placebo group:1 hour pre operatively vaginal vault placed placebo 0.5mg

Sponsors

Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Premenopausal woman with sexual history; (2) Patients who have informed consent and voluntarily agreed to be enrolled in the study; (3) Patients with indications for diagnostic or therapy hysteroscopy; (4) Patients without cardiovascular, liver, kidney or hematopoietic system and other medical diseases; (5) Patients with no contraindications to use prostaglandins; (6) Patients hadnt use steroids within 3 months.

Exclusion criteria

Exclusion criteria: (1) Pregnancy and lactation; (2) Patients who have the past history of cervical incompetence or diseases that can lead to the dilatation of cervix (such as cervical myoma, cervical polyp prolapsed to internal cervical orifice and type 0 submucous myoma); (3) Patients after CKC surgery; (4) Patients who had uterine perforation or have the history of intrauterine operation for cervical dilatation in recent 3 months; (5) Patients who are forbidden to use prostaglandin, such as asthma, cardiovascular diseases, glaucoma and serious allergy sufferers, or those who have intake prostaglandin inhibitor recently; (6) Body temperature>37.5 degree C; (7) Large amount of prolonged activity uterine bleeding; (8) Reproductive tract infections, genital tuberculosis; (9) Cervical cancer; (10) Patients with cardiovascular or cerebrovascular, liver, kidney or hematopoietic system and other serious diseases or mental illness; (11) Patients who havent signed informed consent; (12) Patients who have poor compliance and who cant go on with examination or treatment.

Design outcomes

Primary

MeasureTime frame
The cervical dilation;Adverse drug reaction;

Secondary

MeasureTime frame
Dilatation time;Pain degree;Surgeon satisfaction;Patient Satisfaction;Operating time;The changes of patient‘s symptoms and signs during;Operative complication;

Countries

China

Contacts

Public ContactDuan Hua

Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University

duanhuasci@163.com+86 13501019066

Outcome results

None listed

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