NCT02318225

Brief Summary

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

December 11, 2014

Last Update Submit

September 19, 2015

Conditions

Pain

Keywords

MisoprostolOffice hysteroscopyPain

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    procedure

Secondary Outcomes (1)

  • Operative time

    procedure

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

Placebo is administered vaginally 12 hours before office hysteroscopy

Drug: Placebo

Interventions

MisoprostolDRUG

Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic. Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).

Misoprostol
PlaceboDRUG

Placebo will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic. Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with at least one vaginal delivery who have an indication for office hysteroscopy.

You may not qualify if:

  • Nulliparous patients, menopausal patients and patients with cervical pathology, and previous history of caesarean section or cervical surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynecology Department,Cairo university

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (1)

  • Cicinelli E, Rossi AC, Marinaccio M, Matteo M, Saliani N, Tinelli R. Predictive factors for pain experienced at office fluid minihysteroscopy. J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):485-8. doi: 10.1016/j.jmig.2007.03.008.

    PMID: 17630168BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Usama M Fouda, M.D,PhD

    Cairo University

    STUDY CHAIR

Central Study Contacts

Usama M Fouda, M.D,PhD

CONTACT

01095401375umfrfouda@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 17, 2014

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

EG(1)