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Cervical Preparation in Hysteroscopy

A

Aljazeera Hospital

Status

Unknown

Conditions

GYN Disorders

Treatments

Drug: misoprostol
Drug: dinoprostone

Study type

Interventional

Funder types

Other

Identifiers

NCT03675802
Hysteroscopy

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 42 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups

Arm number one ,misoprostol
Active Comparator group
Treatment:
Drug: misoprostol
Arm number 2 dinoprostone
Active Comparator group
Treatment:
Drug: dinoprostone

Trial contacts and locations

1

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Central trial contact

Mahmoud Alalfy

Data sourced from clinicaltrials.gov

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