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The Effect of Cervical Dilatation on Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT04682262
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Murat Yassa, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study Description
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Brief Summary:
Primary dysmenorrhea (PD) is defined as recurrent, crampy pain occurring with menses in the absence of identifiable pelvic pathology. Standard initial management of PD includes NSAIDs as a first-line treatment and oral contraceptives for the relief of pain and improved daily activity. In patients who have persistent dysmenorrhea despite medical therapy of NSAIDs and/or oral contraceptives, further investigation including pelvic ultrasound, hysteroscopy or laparoscopy may be needed to rule out other underlying pathologies. Historically, It is an old clinical observation that primary dysmenorrhea is often completely or partially relieved by childbearing. Similarly, the investigators have observed that the diagnostic/operative hysteroscopy led to relive of pain in most of the cases in our practice. Therefore, the investigators hypothesized that the process of cervical dilatation can have a role in reducing pain of patients with dysmenorrhea. In this randomized, controlled study, it was aimed to assess the effect of operational cervical dilatation on the pain in patients with primary dysmenorrhea.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Primary Procedure: Cervical dilatation Not Applicable

Detailed Description:
Patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation) will be assessed for the presence of primary dysmenorrhea by history taking and anamnesis. Patients will be randomized to have cervical dilatation and hysteroscopy or no intervention until the follow-up duration.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator diagnosed primary dysmenorrhea with clinical history and anamnesis. Investigator refers the patient to the surgical nurse and nurse performs the randomization process and prepare the patient (control group) for the cervical dilatation and hysteroscopy and schedule the control group for follow-up (expectant). The outcomes assessor is also blind to the assigned group.
Primary Purpose: Treatment
Official Title: The Effect of Cervical Dilatation on Pain in Nulliparous Women With Primary Dysmenorrhea.
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : April 14, 2021
Estimated Study Completion Date : May 21, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cervical dilatation
Patients receive cervical dilatation up to 10 millimeter Hegar dilator under general anaesthesia. Patient undergo standard hysteroscopy operation.
 Procedure: Cervical dilatation
Patients undergo to cervical dilatation prior to the hysteroscopy under general anaesthesia with using Hegar dilator (no.10)
No Intervention: Expectant
Patients are scheduled for follow-up.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Score [ Time Frame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month ]
    Patients are asked to mark their pain on a 10 point visual scale which variate between 0 (no pain) to 10 (unbearable pain).

  2. Verbal multidimensional scoring system for assessment of dysmenorrhea severity [ Time Frame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month ]
    This scale assess the dysmenorrhea by grading the severity. The assessment includes working ability, systemic symptoms and the use of analgesics. The grades vary between grade 0, grade 1 (mild), grade 2 (moderate) and grade 3 (severe).

  3. EQ-5D [ Time Frame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month ]
    The EuroQol-5D (EQ-5D) is an instrument for measuring quality of life and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).


Other Outcome Measures:
  1. dyspareunia [ Time Frame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month ]
    Dyspareunia is assessed by a non-validated question if she feels disturbing pain during the sexual coitus or not (present / absent).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation)
  • Patients whose history and anamnesis indicate primary dysmenorrhea.
  • Aged over 18 years old
  • Nulliparous women

Exclusion Criteria:

  • History of uterine surgery/operation
  • History and clinical examinations which are indicative of secondary dysmenorrhea (Endometriosis, Adenomyosis, Uterine myomas, Endometrial polyps, Cervical stenosis, etc.)
  • Positive pregnancy test
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682262


Contacts
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Contact: Ilkhan Keskin, MD +905344669085 mdilkhankeskin@gmail.com

Locations
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Turkey
Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Ilkhan Keskin, MD    +905344669085    mdilkhankeskin@gmail.com   
Sub-Investigator: Ilkhan Keskin, MD         
Principal Investigator: Niyazi Tug, MD PROF         
Sponsors and Collaborators
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Investigators
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Study Director: Niyazi Tug, MD, Prof Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
More Information
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Publications:

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Responsible Party: Murat Yassa, Principal Investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04682262    
Other Study ID Numbers: CDPD
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murat Yassa, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital:
cervical dilatation
dysmenorrhea
Additional relevant MeSH terms:
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Aneurysm
Dysmenorrhea
Dilatation, Pathologic
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
 Pain
Neurologic Manifestations
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical