Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03638856

Enrollment

Registered

2018-08-20

Start date

2018-09-30

Completion date

2018-12-30

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female

Keywords

Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause

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.

Interventions

DRUGMisoprostol 200Mcg Tab

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
initial cervical diameter	1 year	The initial hedgar dilator number which can easily insert through cervix

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026