NCT03675802

Brief Summary

The hysteroscopy was performed in the proliferativephase of the menstrual cycle. The patients were given generalintravenous anesthesia (propofol/fentanyl) after the vulvar and the vaginal area had been disinfected with a 7.5% Betadinesolution by the surgical nurse All operations were performed by the same surgeon to avoid possible discrepancies between different surgeons.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 23, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

September 16, 2018

Last Update Submit

January 8, 2019

Conditions

GYN Disorders

Outcome Measures

Primary Outcomes (1)

  • The number of women who will require cervical dilatation

    within an hour

Study Arms (2)

Arm number one ,misoprostol

ACTIVE COMPARATOR
Drug: misoprostol

Arm number 2 dinoprostone

ACTIVE COMPARATOR
Drug: dinoprostone

Interventions

misoprostolDRUG

giving misoprostol to this group

Arm number one ,misoprostol
dinoprostoneDRUG

giving dinoprostine

Arm number 2 dinoprostone

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who needs diagnostic hysteroscopy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients of reproductive age
  • have undergone a cesarean section at least once
  • an indication for diagnostic hysteroscopy for menstrualproblems or suspected intrauterine lesions (suchas uterine polyps and filling defects in the uterine cavity) by abnormal findings from hysterosalpingography,ultrasonography, or saline infusion sonography.

You may not qualify if:

  • Patients who delivered vaginally
  • Had undergone any other transcervical or transabdominal uterine and cervical intervention other than cesareansection, such as loop electrosurgical procedures, cervical cryotherapy, cervical biopsies, and spontaneousabortions, previous dilation, and previous electiveabortions.
  • Patients with cervical pathology,e.g. tears or polyps.
  • The patients with a contraindicationto prostaglandins such as hypersensitivity, bronchial asthma, glaucoma, severeasthma, cardiac, liver or kidney diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

MisoprostolDinoprostone

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • mahmoud Alalfy, PhD

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2018

First Posted

September 18, 2018

Study Start

September 23, 2018

Primary Completion

March 1, 2019

Study Completion

March 15, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)