Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

NCT ID: NCT03638856

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Abnormal Uterine Bleeding Chronic Pelvic Pain Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Misoprostal group

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

Group Type EXPERIMENTAL

Misoprostol 200Mcg Tab

Intervention Type DRUG

patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy

Placebo group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Misoprostol 200Mcg Tab

patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Rjcyto2531

Identifier Type: -

Identifier Source: org_study_id

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