Cervical Preparation in Hysteroscopy

NCT ID: NCT03675802

Last Updated: 2019-01-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-23

Study Completion Date

2019-03-15

Brief Summary

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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.

Detailed Description

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Astandard rigid30 hysteroscope (Karl Storz bettocchi hysteroscope) with a 30° viewing angleand an outer sheath diameter 5.5 mm, inner sheath diameter 4.3 mm and scope diameter 2.9 mmwas used in all procedures.

A speculum was introduced into the vagina, and the uterine cervixwas visualized. Initially, the surgeon attempted to passthrough the cervical canal with the tool directly. When thatwas not possible or when the cervical canal was too rigid ortoo tight, the cervix was grasped with a tenaculum.

Conditions

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GYN Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm number one ,misoprostol

Group Type ACTIVE_COMPARATOR

misoprostol

Intervention Type DRUG

giving misoprostol to this group

Arm number 2 dinoprostone

Group Type ACTIVE_COMPARATOR

dinoprostone

Intervention Type DRUG

giving dinoprostine

Interventions

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misoprostol

giving misoprostol to this group

Intervention Type DRUG

dinoprostone

giving dinoprostine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. patients of reproductive age
2. have undergone a cesarean section at least once
3. 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.

Exclusion Criteria

1. Patients who delivered vaginally
2. 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.
3. Patients with cervical pathology,e.g. tears or polyps.
4. The patients with a contraindicationto prostaglandins such as hypersensitivity, bronchial asthma, glaucoma, severeasthma, cardiac, liver or kidney diseases.

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Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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mahmoud Alalfy, PhD

Role: STUDY_CHAIR

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

Locations

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Algazeerah

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Alalfy

Role: CONTACT

01002611058

Facility Contacts

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Mahmoud Alalfy, master

Role: primary

+201002611058

Ahmed Elgazzar, M.D

Role: backup

+201014005959

Other Identifiers

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Hysteroscopy

Identifier Type: -

Identifier Source: org_study_id

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