NCT02142686

Brief Summary

The aim of this study is to compare different filling pressures

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

May 16, 2014

Last Update Submit

January 26, 2016

Conditions

Hysteroscopy

Keywords

HysteroscopyFilling pressures

Outcome Measures

Primary Outcomes (1)

  • adequate visualization of the uterine cavity

    10 minutes after starting the procedure, the operator will document if adequate visualization was achieved using the allocated pressure. If visualization was not adequate, he will document that adequate visualization was not achieved using the allocated pressure and will ask for the pressure to be adjusted.

    10 minutes after starting the procedure.

Secondary Outcomes (2)

  • Pain perceived by the patient

    10 minutes after starting the procedure

  • Pain perceived by the patient 30 minutes after starting the procedure.

    30 minutes after starting the procedure.

Study Arms (3)

Filling pressure 80

ACTIVE COMPARATOR

After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm.

Device: Filling pressure 80

Filling pressure 50.

ACTIVE COMPARATOR

After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg in this group

Device: Filling pressure 50

illing pressure 30

ACTIVE COMPARATOR

After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm Hg.

Device: Filling pressure 30

Interventions

Filling pressure 80DEVICE

After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.

Filling pressure 80
Filling pressure 50DEVICE

After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.

Filling pressure 50.
Filling pressure 30DEVICE

After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm

illing pressure 30

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years
  • Has a clear Indication to have an outpatient hysteroscopy
  • Consent to participate in the study

You may not qualify if:

  • Premenstrual and midmenstrual patients.
  • Patients with missed periods.
  • Patients with known cardiac disease.
  • Patients who need operative hysteroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (4)

  • Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52.

    PMID: 19602758BACKGROUND

  • van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.

    PMID: 17516956BACKGROUND

  • O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015.

    PMID: 20926175BACKGROUND

  • Shahid A, Pathak M, Gulumser C, Parker S, Palmer E, Saridogan E. Optimum uterine filling pressure for outpatient diagnostic hysteroscopy: a double-blind, randomized controlled trial. Reprod Biomed Online. 2014 Jan;28(1):86-91. doi: 10.1016/j.rbmo.2013.07.018. Epub 2013 Sep 14.

    PMID: 24262433BACKGROUND

Study Officials

  • AbdelGany M A Hassan, MRCOG, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 20, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

EG(1)