Determining the Optimal Time Interval Between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized Double-Blind Trial
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Intensity of pain
Overview
Brief Summary
The aim of this study is to determine whether dinoprostone administered 10 hours before office hysteroscopy can relieve pain more effectively compared with dinoprostone administered 3 hours before office hysteroscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Nulliparous patients who have an indication for office hysteroscopy
Exclusion Criteria
- •Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, allergy to dinoprostone
Arms & Interventions
long interval dinoprostone
A small envelope including two labeled plastic bags (A & B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.
Intervention: long interval dinoprostone (Drug)
short interval dinoprostone
A small envelope including two labeled plastic bags (A& B) (each bag containing either 1 dinoprostone tablets(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.
Intervention: short interval dinoprostone (Drug)
Outcomes
Primary Outcomes
Intensity of pain
Time Frame: intraoperative
Intensity of pain by visual analog scale from 0(no pain) to 100 mm(worst pain imaginable)
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Samy aly ashour
assistant professor
Cairo University