The Effect of Cervical Dilatation on Primary Dysmenorrhea

The Effect of Cervical Dilatation on Pain in Nulliparous Women With Primary Dysmenorrhea.

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.

Study Overview

• Status: Recruiting
• Conditions: Dysmenorrhea Primary
• Intervention / Treatment: Procedure: Cervical dilatation

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilkhan Keskin, MD; Phone Number: +905344669085; Email: mdilkhankeskin@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
    • Contact: Ilkhan Keskin, MD; Phone Number: +905344669085; Email: mdilkhankeskin@gmail.com
    • Sub-Investigator: Ilkhan Keskin, MD
    • Principal Investigator: Niyazi Tug, MD PROF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Score	Patients are asked to mark their pain on a 10 point visual scale which variate between 0 (no pain) to 10 (unbearable pain).	Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
Verbal multidimensional scoring system for assessment of dysmenorrhea severity	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).	Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
EQ-5D	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).	Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Investigators: Study Director: Niyazi Tug, MD, Prof, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Publications and helpful links

General Publications

• Gregersen H, Hee L, Liao D, Uldbjerg N. Distensibility and pain of the uterine cervix evaluated by novel techniques. Acta Obstet Gynecol Scand. 2016 Jul;95(7):717-23. doi: 10.1111/aogs.12891. Epub 2016 Mar 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2020
• Primary Completion (ANTICIPATED): April 14, 2021
• Study Completion (ANTICIPATED): May 21, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (ACTUAL): December 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: dysmenorrhea; cervical dilatation
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Dilatation, Pathologic
• Other Study ID Numbers: CDPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No