Recruitment

Recruitment Status
Completed

Inclusion Criterias

non pregnant patients
considered medically fit without any life threatening conditions
scheduled for operative hysteroscopy, regardless of age or indication of the hysteroscopy
non pregnant patients
considered medically fit without any life threatening conditions
scheduled for operative hysteroscopy, regardless of age or indication of the hysteroscopy

Exclusion Criterias

using other products that could affect the consistency of the cervix such as local estrogen or laminaire
a positive history of vascular or coronary artery disease
using other products that could affect the consistency of the cervix such as local estrogen or laminaire
a positive history of vascular or coronary artery disease

Summary

Conditions
  • Adverse Effects
  • Cervical Laceration
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 125 years
Gender
Only females

Description

All patients admitted for hysteroscopy were offered participation in the study, and those choosing to participate were assessed according to the inclusion and exclusion criteria of the study protocol. The investigators included all non pregnant patients who were considered medically fit and schedule...

All patients admitted for hysteroscopy were offered participation in the study, and those choosing to participate were assessed according to the inclusion and exclusion criteria of the study protocol. The investigators included all non pregnant patients who were considered medically fit and scheduled for operative hysteroscopy, regardless of age or indication of the hysteroscopy. Patients with a positive history of vascular or coronary artery disease and patients using other products that could affect the consistency of the cervix such as local estrogen or laminaire were excluded from the study. To achieve a mean difference of 0.5 in the diffculty of dilation and a mean difference of 0.5 in the First Hegar with a power of 80% at 0.05 statistical significance, a sample of 163 patients in each arm is needed. However, the investigators patients pool did not permit to recruit more than 70 women so the investigators took it as a convenience sample of a total of 70 women that agreed to be recruited for the trial. An informed consent was obtained after explaining to the patients the benefit and the eventual risk or adverse effects associated with the medication. Studied factors were: age, parity, reason for the procedure, history of cervical dilation and history of cervical surgery. Seventy closed and numbered envelopes, containing a capsule with either 200mcg or 400mcg of misoprostol were randomly distributed to these 70 patients. Each envelope was coded randomly and only the pharmaceutical department of the hospital knew the content of these envelopes and kept a list of their codes. The misoprostol was administered by the floor nurse, per-os to the patient one hour before hysteroscopy with a small amount of water. The number on the envelope was noted by the nurse on the document relative to the patient. Hence, the patient, the physician performing the biopsy, the nurse and the research associate did not know the exact dose of misoprostol that was ingested by the patient. Three physicians contributed to the study. Before beginning the procedure, the operator noted by pelvic examination the position of the cervix. He then noted the size/number of the first Hegar dilator used, the maximal dilation reached, the difficulty to dilate during the intervention (measured by a scale from 1 to 10), cervical injuries, bleeding or uterine perforation and the duration of the operation. A rigid hysteroscope (Storz, 27 F) was used for all procedures. Adverse effects that could be related to misoprostol (uterine cramps, nausea, vomiting, diarrhea and fever), were reported before and up to 6 hours after surgery. Statistical analysis was performed using SPSS version 18. Means comparison was done using t-test for continuous variables such as difficulty in dilation or first Hegar (the data was normally distributed). Frequency and percent distribution were compared between the two treatment groups using χ2 test when the expected cell count was 5 or more; in cases where the expected cell count was less than 5, the Fisher exact test was used instead

Inclusion Criterias

non pregnant patients
considered medically fit without any life threatening conditions
scheduled for operative hysteroscopy, regardless of age or indication of the hysteroscopy
non pregnant patients
considered medically fit without any life threatening conditions
scheduled for operative hysteroscopy, regardless of age or indication of the hysteroscopy

Exclusion Criterias

using other products that could affect the consistency of the cervix such as local estrogen or laminaire
a positive history of vascular or coronary artery disease
using other products that could affect the consistency of the cervix such as local estrogen or laminaire
a positive history of vascular or coronary artery disease

Locations

Beirut, 11234
Beirut, 11234

Tracking Information

NCT #
NCT02159911
Collaborators
Not Provided
Investigators
  • Principal Investigator: Assaad K Kesrouani, MD Saint-Joseph University
  • Assaad K Kesrouani, MD Saint-Joseph University