Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02056717
Other study ID # 4-2013-0863
Secondary ID
Status Completed
Phase N/A
First received February 3, 2014
Last updated April 15, 2015
Start date April 2014
Est. completion date April 2015

Study information

Verified date April 2015
Source Severance Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to investigate the effects of dexamethasone on inflammatory reactions after uterine artery embolization. The secondary purpose of this study it to investigate the effects of dexamethasone on postembolization syndrome (severe pain, nasea and vomiting).


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Uterine artery embolization due to multiple myoma or adenomyosis

Exclusion Criteria:

- Diabetic mellitus

- Steroid administration

- Liver or kidney dysfuntion

- High baseline CRP or leukocytosis (>11,000/µL )

- Drug allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Administration of dexamethasone 10 mg IV 1 h before UAE
Normal saline
Administration of normal saline 2 mL IV 1 h before UAE

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammatory reactions CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h 24 hours Yes
Secondary Pain Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h 24 hours Yes
Secondary Nausea and vomiting Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h 24 hours Yes
Secondary Sucessful rate at 3 month after UAE Utrerine volume and complete necrosis incidence 3 month No
See also
  Status Clinical Trial Phase
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Recruiting NCT04209127 - Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis N/A
Completed NCT05751876 - Dienogest in Perimenopausal Women With Adenomyosis
Recruiting NCT01048931 - Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Phase 3
Active, not recruiting NCT06223464 - Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix
Completed NCT05419414 - The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis N/A
Recruiting NCT05152667 - Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin
Not yet recruiting NCT03654144 - Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Phase 4
Completed NCT02192606 - Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? N/A
Completed NCT01992718 - What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Early Phase 1
Recruiting NCT02495311 - The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
Recruiting NCT03742843 - A Multi-omics Study of Adenomyosis
Recruiting NCT04481321 - Clinical and Molecular Study of Endometriosis and Adenomyosis
Recruiting NCT04894292 - The Effect of Adenomoyosis on Pregnancy Outcomes
Completed NCT03520439 - Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Phase 2/Phase 3
Recruiting NCT05937490 - Adenomyosis and ART Phase 4
Recruiting NCT06373822 - New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
Completed NCT01821001 - Vaginal Bromocriptine for Treatment of Adenomyosis Phase 1
Recruiting NCT04295109 - Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function N/A
Recruiting NCT04356664 - Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Phase 2/Phase 3