NCT03276000

Brief Summary

The objective of the present study is to evaluate the appropriate route of administration of misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of office hysteroscopy and reduce patient discomfort to minimum

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

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

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

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

September 6, 2017

Last Update Submit

October 14, 2017

Conditions

Misoprostol Allergy

Keywords

Misoprostol ,office hysteroscopy

Outcome Measures

Primary Outcomes (2)

  • Pain sensation:

    the level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).

    The VAS will be applied immediately after the procedure ended.

  • Patient acceptability

    according to a 10-point VAS

    The VAS will be applied immediately after the procedure ended.

Secondary Outcomes (3)

  • Bleeding

    during the procedure.

  • Procedure time

    it will be reported immediately after the process ended

  • Ease of cervical entry by hysteroscopy

    The VAS will be applied immediately after the procedure ended.

Study Arms (2)

Group A

ACTIVE COMPARATOR

50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy

Procedure: office hysteroscopy

group B

ACTIVE COMPARATOR

50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy moistened with saline solution will be inserted in posterior fornix of vagina.

Procedure: office hysteroscopy

Interventions

office hysteroscopyPROCEDURE

A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.

Group Agroup B

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients indicated for diagnostic hysteroscopy for infertility or AUB.
  • Reproductive age \>19 - 45yrs.
  • Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

You may not qualify if:

  • Contraindicating the use of prostaglandins such as:-
  • Cardiovascular disease
  • Severe bronchial asthma.
  • Hypertension.
  • Renal failure.
  • Known sensitivity to Prostaglandins
  • Contraindication to office hysteroscopy such as:-
  • Pelvic inflammatory disease.
  • Marked cervical stenosis.
  • Known cervical malignancy.
  • pregnancy
  • profuse uterine bleeding
  • Recent uterine perforation.
  • Neurological disorders affecting the evaluation of pain.
  • Previous cervical surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

RECRUITING

Related Publications (3)

  • Sordia-Hernandez LH, Rosales-Tristan E, Vazquez-Mendez J, Merino M, Iglesias JL, Garza-Leal JG, Morales A. Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients. Fertil Steril. 2011 Feb;95(2):759-61. doi: 10.1016/j.fertnstert.2010.07.1066. Epub 2010 Aug 21.

    PMID: 20728083BACKGROUND

  • Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1.

    PMID: 23701149BACKGROUND

  • El-Mazny A, Abou-Salem N. A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. Fertil Steril. 2011 Oct;96(4):962-5. doi: 10.1016/j.fertnstert.2011.04.049. Epub 2011 May 14.

    PMID: 21575939BACKGROUND

Central Study Contacts

Sarah M Hassan, lecturer

CONTACT

01003733671saramohamed7880@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology Cairo university

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 8, 2017

Study Start

October 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 17, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)