Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy

NCT01620814 | Unknown Phase 4

• 1 other identifier: 2012-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL Objective. Comparison with one another and with control group of vaginal dinoprostol and misoprostol with for the purpose of cervical ripening before diagnostic hysteroscopy. Population: It was planned for performing to 95 women who appealed to gynecology polyclinic and will be performed diagnostic hysteroscopy. Methods: Eighty-six women who will be performed diagnostic hysteroscopy assigned as randomize to three groups. It was planned that none procedure will be applied to group 1 for cervical ripening, vaginal misoprostol and vaginal dinoprostone will be practiced to Groups 2 and 3, respectively.

Conditions

Cervical Ripening

Keywords

misoprostol; dinoprostone; cervical ripening; diagnostic hysteroscopy

Outcome Measures

Primary Outcomes (2)

• need for cervical dilatation

  In the all three groups, patients being necessary cervical dilatation will be determined and their rates will be calculated.

  2 Months

• Duration of cervical dilatation

  In the patients being necessary cervical dilatation, elapsed time for dilatation will be calculated.

  2 Months

Secondary Outcomes (3)

• Ease of dilatation

  2 Months

• Dilatation complications

  2 Months

• Adverse effects

  2 Months

Study Arms (3)

Dinoprostone and misoprostol

EXPERIMENTAL

For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie. After drugs administration, cervical canal will be again evaluated with above mentioned way by bougie before hysteroscopy

Drug: Dinoprostone; Drug: misoprostol

Misoprostol and control

EXPERIMENTAL

For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.

Drug: misoprostol; Drug: control

dinoprostone and control

EXPERIMENTAL

For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.

Drug: Dinoprostone; Drug: control

Interventions

Dinoprostone DRUG

Also known as: group 3

Dinoprostone and misoprostol; dinoprostone and control

misoprostol DRUG

Also known as: group 2

Dinoprostone and misoprostol; Misoprostol and control

control DRUG

Also known as: group 1

Misoprostol and control; dinoprostone and control

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• on the HSG,USG or SIS,
• women at the age of primary or secondary infertile reproductive suspected for intrauterine pathology,
• no contraindication for hysteroscopy and reproductive age

You may not qualify if:

• women are with allergy against to prostaglandins,
• with diseases in which prostaglandin usage is contraindicated,
• pregnant,
• don't given approval,
• with cervical surgery history and cervical insufficiency.

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Women Health Education Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Inal HA, Ozturk Inal ZH, Tonguc E, Var T. Comparison of vaginal misoprostol and dinoprostone for cervical ripening before diagnostic hysteroscopy in nulliparous women. Fertil Steril. 2015 May;103(5):1326-31. doi: 10.1016/j.fertnstert.2015.01.037. Epub 2015 Feb 21.

  PMID: 25712577 DERIVED

MeSH Terms

Interventions

Dinoprostone; Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E, Synthetic; Prostaglandins, Synthetic

Central Study Contacts

Esra Tonguc, M.D.

CONTACT

053241414889; esratonguc@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 15, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

TU (1)