Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Infertility, Female Clinical Trial

Official title:

Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638856
• Other study ID #: Rjcyto2531
• Status: Completed
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: June 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo

Description:

Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Premenopausal women

2. Patients have following indication for diagnosis hysteroscopy

• Abnormal uterine bleeding

• Unexplained infertility

• Recurrent pregnancy loss

• Chronic pelvic pain

• Late postpartum hemorrhage

3. Patients provided written informed consent

Exclusion Criteria:

1. Postmenopausal women

2. Patients who have contraindication for Misoprostal as following

• Allergic to Misoprostal

• Medical illnesses such as cardiovascular diseases, Asthma, Renal disease

3. Patients who have contraindication for Hysteroscopoy as following

• Pregnant women

• Pelvic inflammatory disease

• Infection at cervix and vagina

• Cervical cancer

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Chronic Pelvic Pain
• Infertility
• Infertility, Female
• Pelvic Pain
• Uterine Hemorrhage

Intervention

Drug:
• Misoprostol 200Mcg Tab
patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	initial cervical diameter	The initial hedgar dilator number which can easily insert through cervix	1 year