NCT03638856

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

October 22, 2020

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

June 1, 2018

Last Update Submit

October 20, 2020

Conditions

Abnormal Uterine BleedingChronic Pelvic PainInfertility, Female

Keywords

Cervical primingDiagnosis hysteroscopyOral MisoprostalPremenopause

Outcome Measures

Primary Outcomes (1)

  • initial cervical diameter

    The initial hedgar dilator number which can easily insert through cervix

    1 year

Study Arms (2)

Misoprostal group

EXPERIMENTAL

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

Drug: Misoprostol 200Mcg Tab

Placebo group

NO INTERVENTION

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

Interventions

Misoprostol 200Mcg TabDRUG

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

Misoprostal group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsneed to evaluation of cervical priming
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

MetrorrhagiaInfertility, Female

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInfertility

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

August 20, 2018

Study Start

September 30, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

October 22, 2020

Record last verified: 2018-06

Locations

TH(1)