Comparison Between 200 μg and 800 μg of Misoprostol for Cervical Ripening Prior to Operative Hysteroscopy: Randomized and Quadruple Blind Clinical Trial.
Sponsor study identifier
interventional
80
1 country
1
Study Start
November 7, 2019
Actual (reported)Primary Completion
September 11, 2020
Actual (reported)Study Completion
September 12, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 12, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2019
Actual (reported)November 5, 2019
Actual (reported)November 7, 2019
Actual (reported)September 11, 2020
Actual (reported)September 12, 2020
Actual (reported)Cervical canal width.
Maximum size of dilator that passes through the internal os without resistance.
during the surgery
Time required to dilate the cervix to 9mm.
during the surgery
Ease of cervical dilation.
during the surgery
Length of the cervix.
during the surgery
Abandonment of the procedure due to cervical dilation failure.
during the surgery
Intraoperative complications.
during the surgery
In this group, the participants will receive 200mcg of misoprostol, single dose, via the vaginal route.
In this group, the participants will receive 800mcg of misoprostol, single dose, via the vaginal route.
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.
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.
Maria da Conceição Souto Maior
Recife, Pernambuco, 52.050-020, Brazil
Maior MDCFS, Souza ASR, Souza GFA, da Costa AAR. Comparison between 200 mug and 800 mug of vaginal misoprostol for cervical ripening before operative hysteroscopy: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Jul;158(1):205-212. doi: 10.1002/ijgo.13984. Epub 2021 Nov 3.
Aurélio Costa, PhD
Instituto Materno Infantil Prof. Fernando Figueira
80 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2019
First Posted
November 5, 2019
Study Start
November 7, 2019
Actual (reported)Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
Contact the study team to confirm eligibility.
Primary Completion
September 11, 2020
Actual (reported)Study Completion
September 12, 2020
Actual (reported)Last Updated
October 8, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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