Cervical Preparation in Hysteroscopy

Sponsor

Aljazeera Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03675802

Collaborator

Cairo University (Other)

100

Enrollment

Location

Arms

5.7

Anticipated Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GYN Disorders	Drug: misoprostol Drug: dinoprostone	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 23, 2018

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Mar 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm number one ,misoprostol	Drug: misoprostol giving misoprostol to this group
Active Comparator: Arm number 2 dinoprostone	Drug: dinoprostone giving dinoprostine

Arm

Intervention/Treatment

Active Comparator: Arm number one ,misoprostol

Drug: misoprostol

giving misoprostol to this group

Active Comparator: Arm number 2 dinoprostone

Drug: dinoprostone

giving dinoprostine

Outcome Measures

Primary Outcome Measures

The number of women who will require cervical dilatation [within an hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Algazeerah	Giza		Egypt

Sponsors and Collaborators

Aljazeera Hospital
Cairo University

Investigators

Study Chair: mahmoud Alalfy, PhD, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aljazeera Hospital

ClinicalTrials.gov Identifier:

NCT03675802

Other Study ID Numbers:

Hysteroscopy

First Posted:

Sep 18, 2018

Last Update Posted:

Jan 9, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Misoprostol

Dinoprostone

Study Results

No Results Posted as of Jan 9, 2019