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Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Primary Purpose

Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Misoprostol 200Mcg Tab
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding focused on measuring Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Misoprostal group

Placebo group

Arm Description

Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy

Patients were take placebo 2 tab per oral 3 hour before hysteroscopy

Outcomes

Primary Outcome Measures

initial cervical diameter
The initial hedgar dilator number which can easily insert through cervix

Secondary Outcome Measures

Full Information

First Posted
June 1, 2018
Last Updated
October 20, 2020
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03638856
Brief Title
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
Official Title
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female
Keywords
Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostal group
Arm Type
Experimental
Arm Description
Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy
Arm Title
Placebo group
Arm Type
No Intervention
Arm Description
Patients were take placebo 2 tab per oral 3 hour before hysteroscopy
Intervention Type
Drug
Intervention Name(s)
Misoprostol 200Mcg Tab
Intervention Description
patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy
Primary Outcome Measure Information:
Title
initial cervical diameter
Description
The initial hedgar dilator number which can easily insert through cervix
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
need to evaluation of cervical priming
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premenopausal women Patients have following indication for diagnosis hysteroscopy Abnormal uterine bleeding Unexplained infertility Recurrent pregnancy loss Chronic pelvic pain Late postpartum hemorrhage Patients provided written informed consent Exclusion Criteria: Postmenopausal women Patients who have contraindication for Misoprostal as following Allergic to Misoprostal Medical illnesses such as cardiovascular diseases, Asthma, Renal disease Patients who have contraindication for Hysteroscopoy as following Pregnant women Pelvic inflammatory disease Infection at cervix and vagina Cervical cancer
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

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Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

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