Clinical trial NCT04682262: The Effect of Cervical Dilatation on Primary Dysmenorrhea
Official title: The Effect of Cervical Dilatation on Pain in Nulliparous Women With Primary Dysmenorrhea.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea Primary
Keywords: cervical dilatation
dysmenorrhea
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Visual Analogue Score
timeFrame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
measure: Verbal multidimensional scoring system for assessment of dysmenorrhea severity
timeFrame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
measure: EQ-5D
timeFrame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
Secondary outcomes:
Other outcomes:
measure: dyspareunia
timeFrame: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
Locations:
city: Istanbul
country: Turkey
facility: Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
Study officials:
affiliation: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
name: Niyazi Tug, MD, Prof
role: STUDY_DIRECTOR
References:
citation: 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.