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Dose Comparison of Misoprostol for Cervix Ripening Before Operative Hysteroscopy.

NCT04152317 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-10-08

No results posted yet for this study

Summary

The medication misoprostol is used to facilitate the entry into the uterus of hysteroscopy surgery equipment and this research aims to compare the results of the use of this drug in two different doses trying to find the optimal one.

To perform this work we will use the misoprostol and will perform a questionnaire that will be asked during hospitalization, before, during and the 12hours after the surgery.

The patients who meet the inclusion criteria after signing the Informed Consent Form will be allocated into two groups getting misoprostol 200mcg or misoprostol 800mcg.

Conditions

  • Cervix; Open

Interventions

DRUG

Misoprostol 200mcg Tab

In the misoprostol 200mcg group there will be one tablet of 200mcg and three identical tablets in shape, size and color without pharmacological properties. These four tablets will be single dose administered via vaginal route for each participant.

DRUG

Misoprostol 800mcg Tab

In the misoprostol 800mcg group there will be four tablets of 200mcg. These four tablets will be single dose administered via vaginal route for each participant.

Sponsors & Collaborators

  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Principal Investigators

  • Aurélio Costa, PhD · Instituto Materno Infantil Prof. Fernando Figueira

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2020-09-11
Completion
2020-09-12

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04152317 on ClinicalTrials.gov