NCT01718314

Brief Summary

Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

October 29, 2012

Last Update Submit

October 30, 2012

Conditions

Pain During Hysteroscopy

Keywords

HysteroscopyMisoprostolLidocaineVisual analogue score

Outcome Measures

Primary Outcomes (1)

  • Patient VAS score immediately after the procedure

    Immediately after the procedure

Secondary Outcomes (1)

  • Patient VAS score 10 minutes after the procedure

    10 minutes after the procedure

Other Outcomes (1)

  • Need for cervical dilation

    During the procedure

Study Arms (2)

Sublingual Misoprostol & Lidocaine placebo

EXPERIMENTAL

Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo

Drug: Sublingual MisoprostolDrug: Placebo (for Lidocaine)

Lidocaine Pump Spray & Misoprostol placebo

EXPERIMENTAL

Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo

Drug: Lidocaine pump sprayDrug: Placebo (for Misoprostol)

Interventions

Sublingual MisoprostolDRUG
Also known as: Cytotec
Sublingual Misoprostol & Lidocaine placebo
Lidocaine pump sprayDRUG
Also known as: Xylocaine %10 pump spray
Lidocaine Pump Spray & Misoprostol placebo
Placebo (for Misoprostol)DRUG

Lactose filler, the pharmacy-produced pills identical to original misoprostol pill

Lidocaine Pump Spray & Misoprostol placebo
Placebo (for Lidocaine)DRUG

The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray

Sublingual Misoprostol & Lidocaine placebo

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy

You may not qualify if:

  • vaginal bleeding at the time of the procedure
  • known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins
  • epilepsy
  • significantly impaired respiratory or cardiac conduction functions
  • hypertension
  • glaucoma
  • renal failure
  • acute liver disease
  • uncontrolled diabetes mellitus
  • pregnancy or suspicion of pregnancy
  • pelvic inflammatory disease
  • cervical operation history
  • vaginismus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Sami Ulus Maternity and Children Training and Research Hospital

Ankara, 06090, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 17516956RESULT

  • De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.

    PMID: 10648742RESULT

  • Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24.

    PMID: 19243750RESULT

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tuncay Kucukozkan, Professor

    Sami Ulus Maternity and Childrens Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrician and Gynecologist

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 31, 2012

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

TU(1)