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Cervical Preparation in Hysteroscopy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03675802
Enrollment
100
Registered
2018-09-18
Start date
2018-09-23
Completion date
2019-03-15
Last updated
2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GYN Disorders

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.

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.

Interventions

DRUGmisoprostol

giving misoprostol to this group

DRUGdinoprostone

giving dinoprostine

Sponsors

Cairo University
CollaboratorOTHER
Aljazeera Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frame
The number of women who will require cervical dilatationwithin an hour

Countries

Egypt

Contacts

Primary ContactMahmoud Alalfy
mahmoudalalfy@ymail.com01002611058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026