The Effect of Cervical Dilatation on Primary Dysmenorrhea

NCT04682262 | Unknown

• 1 other identifier: CDPD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea Primary

Keywords

cervical dilatation; dysmenorrhea

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• dyspareunia

  Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month

Study Arms (2)

Cervical dilatation

EXPERIMENTAL

Patients receive cervical dilatation up to 10 millimeter Hegar dilator under general anaesthesia. Patient undergo standard hysteroscopy operation.

Procedure: Cervical dilatation

Expectant

NO INTERVENTION

Patients are scheduled for follow-up.

Interventions

Cervical dilatation PROCEDURE

Patients undergo to cervical dilatation prior to the hysteroscopy under general anaesthesia with using Hegar dilator (no.10)

Cervical dilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 26946059 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Labor Stage, First

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Labor Onset; Labor, Obstetric; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Niyazi Tug, MD, Prof

  Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Ilkhan Keskin, MD

CONTACT

+905344669085; mdilkhankeskin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 23, 2020
• Study Start: December 14, 2020
• Primary Completion: April 14, 2021
• Study Completion: May 21, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)