NCT02142673

Brief Summary

The study aims to compare different filling pressures in operative outpatient hysteroscopy. Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40mmHg in group 3.

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

Typical duration for not_applicable

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
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

May 16, 2014

Last Update Submit

August 2, 2016

Conditions

Hysteroscopy

Keywords

Operative hysteroscopyFilling pressure

Outcome Measures

Primary Outcomes (1)

  • Completing the procedure with the allocated pressure

    The operator will document if he is able to complete the operative procedure with the allocated pressure. If the operator is not able to operate with the allocation pressure, he will document that the procedure cannot be completed with the current pressure and will ask for the filling pressure to be adjusted

    30 minutes after starting the procedure

Secondary Outcomes (2)

  • Pain perception during the procedure

    10 minutes after starting the procedure

  • Pain perception after the procedure

    30 minutes after completing the procedure

Study Arms (3)

Filling pressure 80

ACTIVE COMPARATOR

The hysteroscope filling pressure will be 80mm Hg

Device: Filling pressure 80

Filling pressure 60

ACTIVE COMPARATOR

The hysteroscope filling pressure will be to 50mm Hg

Device: Filling pressure 60

Filling pressure 40

ACTIVE COMPARATOR

The hysteroscope filling pressure will be to 40mm Hg

Device: Filling pressure 40

Interventions

Filling pressure 80DEVICE

The hysteroscope filling pressure will be 80mm Hg

Filling pressure 80
Filling pressure 60DEVICE

The hysteroscope filling pressure will be reduced to 50mm Hg

Filling pressure 60
Filling pressure 40DEVICE

The hysteroscope filling pressure will be 40mm Hg

Filling pressure 40

Eligibility Criteria

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

You may qualify if:

  • Age 18-60 years
  • Indication to have an operative outpatient hysteroscopy like endometrial polyp, need for endometrial biopsy, intrauterine adhesions, intra uterine device (IUD) retrieval or intrauterine septum resection.
  • Consents to participate in the study

You may not qualify if:

  • Premenstrual and mid-menstrual patients.
  • Patients with missed periods.
  • Patients with known cardiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (5)

  • 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

  • Haggag H, Hassan A, Wahba A, Joukhadar R. A randomized double-blind controlled trial of different filling pressures in operative outpatient hysteroscopy. Int J Gynaecol Obstet. 2017 Oct;139(1):55-60. doi: 10.1002/ijgo.12247. Epub 2017 Jul 25.

    PMID: 28653328DERIVED

Study Officials

  • AbdelGany MA 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

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

EG(1)