Cervical Preparation Prior to Hysteroscopy Clinical Trial
Official title:
Same-day Cervical Preparation With Misoprostol Before Hysteroscopy: a Randomized Trial of Different Routes of Administration
This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | July 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center - Written consent supplied Exclusion Criteria: - Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure) - Prostaglandin allergy - Pregnancy - Genital infection - Space-occupying lesion in the endocervical canal - Prior cervical surgery |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Israel | Edith Wolfson Medical Center | Holon |
| Lead Sponsor | Collaborator |
|---|---|
| Wolfson Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Preoperative cervical width in centimeters | Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width. | intraoperative | No |
| Secondary | Time required to achieve cervical dilatation | The time in minutes required for dilatation up to a number 10 Hegar | intraoperative | No |
| Secondary | Ease of cervical dilatation | The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy) | intraoperative | No |
| Secondary | Patient preference | Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable) | baseline | No |
| Secondary | Adverse effects of medication | Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting) | baseline | No |
| Secondary | Surgical complications | Complications arising during surgery (perforation, cervical laceration, excess bleeding) | intraoperative | No |