Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Rajavithi Hospital

Status: Completed

Conditions: Chronic Pelvic Pain; Abnormal Uterine Bleeding; Infertility, Female

Treatments: Drug: Misoprostol 200Mcg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT03638856

Rjcyto2531

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Misoprostal group

Experimental group

Description:

Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy

Treatment:

Drug: Misoprostol 200Mcg Tab

Placebo group

No Intervention group

Description:

Patients were take placebo 2 tab per oral 3 hour before hysteroscopy