Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

• Sponsor: Rajavithi Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03638856
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Abnormal Uterine Bleeding; Chronic Pelvic Pain; Infertility, Female	Drug: Misoprostol 200Mcg Tab	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial
• Actual Study Start Date: Sep 30, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Misoprostal group Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy	Drug: Misoprostol 200Mcg Tab; patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy
No Intervention: Placebo group Patients were take placebo 2 tab per oral 3 hour before hysteroscopy

Outcome Measures

Primary Outcome Measures

1. initial cervical diameter [1 year]

   The initial hedgar dilator number which can easily insert through cervix

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

1. 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

1. Patients who have contraindication for Hysteroscopoy as following

• Pregnant women

• Pelvic inflammatory disease

• Infection at cervix and vagina

• Cervical cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rajavithi Hospital	Bangkok		Thailand	10400

Sponsors and Collaborators

• Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rajavithi Hospital
• ClinicalTrials.gov Identifier: NCT03638856
• Other Study ID Numbers: Rjcyto2531
• First Posted: Aug 20, 2018
• Last Update Posted: Oct 22, 2020
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Rajavithi Hospital: Cervical priming; Diagnosis hysteroscopy; Oral Misoprostal; Premenopause
• Additional relevant MeSH terms: Infertility; Infertility, Female; Uterine Hemorrhage; Pelvic Pain; Misoprostol

Study Results

No Results Posted as of Oct 22, 2020