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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

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:

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

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

NCT ID

NCT03638856

First Posted

June 1, 2018

Last Updated

October 20, 2020

Sponsor

Rajavithi Hospital

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

Learn more about this trial

Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

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