The Effect of Cervical Dilatation on Primary Dysmenorrhea

Last updated: March 18, 2021
Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Female Hormonal Deficiencies/abnormalities

Severe Premenstrual Symptom

Treatment

N/A

Clinical Study ID

NCT04682262
CDPD
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 40
Study Start date:
December 14, 2020
Estimated Completion Date:
May 21, 2021

Study 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.

Connect with a study center

  • Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

    Istanbul,
    Turkey

    Active - Recruiting

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