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The Effect of Cervical Dilatation on Primary Dysmenorrhea

S

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

Status

Unknown

Conditions

Dysmenorrhea Primary

Treatments

Procedure: Cervical dilatation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Cervical dilatation
Experimental group
Description:
Patients receive cervical dilatation up to 10 millimeter Hegar dilator under general anaesthesia. Patient undergo standard hysteroscopy operation.
Treatment:
Procedure: Cervical dilatation
Expectant
No Intervention group
Description:
Patients are scheduled for follow-up.

Trial contacts and locations

1

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Central trial contact

Ilkhan Keskin, MD

Data sourced from clinicaltrials.gov

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