Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Not Applicable

Completed

• Conditions: Chronic Pelvic Pain; Abnormal Uterine Bleeding; Infertility, Female
• Interventions: Drug: Misoprostol 200Mcg Tab

• Registration Number: NCT03638856
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Study Start: 2018-09-30
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

1. Premenopausal women

2. Patients have following indication for diagnosis hysteroscopy

   • Abnormal uterine bleeding
   • Unexplained infertility
   • Recurrent pregnancy loss
   • Chronic pelvic pain
   • Late postpartum hemorrhage

3. Patients provided written informed consent

Exclusion Criteria

1. Postmenopausal women

2. Patients who have contraindication for Misoprostal as following

   • Allergic to Misoprostal
   • Medical illnesses such as cardiovascular diseases, Asthma, Renal disease

3. Patients who have contraindication for Hysteroscopoy as following

   • Pregnant women
   • Pelvic inflammatory disease
   • Infection at cervix and vagina
   • Cervical cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostal group	Misoprostol 200Mcg Tab	Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy

Primary Outcome Measures

Name	Time	Method
initial cervical diameter	1 year	The initial hedgar dilator number which can easily insert through cervix

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand