The Effect of Cervical Dilatation on Primary Dysmenorrhea

Dysmenorrhea Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04682262
• Other study ID #: CDPD
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: May 21, 2021

Study information

• Verified date: March 2021
• Source: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: Ilkhan Keskin, MD
• Phone: +905344669085
• Email: mdilkhankeskin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 21, 2021
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Dysmenorrhea
• Dysmenorrhea Primary

Intervention

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

Locations

Country	Name	City	State
Turkey	Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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