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NCT Number: NCT03638856

Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo

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Key information

Conditions

Abnormal Uterine Bleeding Chronic Pelvic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Infertility Infertility, Female Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

About this study

Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premenopausal women
  • Patients have following indication for diagnosis hysteroscopy
  • Abnormal uterine bleeding
  • Unexplained infertility
  • Recurrent pregnancy loss
  • Chronic pelvic pain
  • Late postpartum hemorrhage
  • Patients provided written informed consent

Exclusion criteria

  • Postmenopausal women
  • Patients who have contraindication for Misoprostal as following
  • Allergic to Misoprostal
  • Medical illnesses such as cardiovascular diseases, Asthma, Renal disease
  • Patients who have contraindication for Hysteroscopoy as following
  • Pregnant women
  • Pelvic inflammatory disease
  • Infection at cervix and vagina
  • Cervical cancer

Treatment and study plan

Misoprostol 200Mcg Tab

Drug

patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy

Primary outcomes

  1. initial cervical diameter

    Time frame: 1 year

    The initial hedgar dilator number which can easily insert through cervix

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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