Cervical Preparation in Hysteroscopy

GYN Disorders Clinical Trial

Official title:

Randomized Comparison of Vaginal Dinoprostone and Misoprostol for Cervical Ripening Before Diagnostic Hysteroscopy in Patients Who Have Undergone Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03675802
• Other study ID #: Hysteroscopy
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: January 2019
• Source: Aljazeera Hospital
• Contact: Mahmoud Alalfy
• Phone: 01002611058
• Email: mahmoudalalfy[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 15, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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 ?lling defects in the uterine cavity) by abnormal ?ndings 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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• GYN Disorders

Intervention

Drug:
• misoprostol
giving misoprostol to this group
• dinoprostone
giving dinoprostine

Locations

Country	Name	City	State
Egypt	Algazeerah	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Aljazeera Hospital	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of women who will require cervical dilatation		within an hour