Clinical trial NCT04152317: Dose Comparison of Misoprostol for Cervix Ripening Before Operative Hysteroscopy.
Official title: Comparison Between 200 μg and 800 μg of Misoprostol for Cervical Ripening Prior to Operative Hysteroscopy: Randomized and Quadruple Blind Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervix; Open
Keywords: Operative Hysteroscopy
Misoprostol
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Background: Hysteroscopy represents a minimally invasive procedure that has been increasing its adoption in the treatment of many cervical canal and uterine cavity disorders. However, difficulties related to the introduction of the equipment through the cervix are frequent. Although several studies suggest advantages in the cervical preparation with misoprostol, reducing the resistance of the uterine cervix, systematic reviews are unison to indicate the need for clarification on the ideal dose.

Aim: Compare the intra and postoperative results of patients submitted to cervical dilatation for surgical hysteroscopy with previous use of misoprostol at doses of 200mcg or 800mcg for uterine cervix preparation at Recife school hospitals.

Methods: Randomized, quadruple-blind clinical trial with patients who underwent cervical dilatation prior to surgical hysteroscopy at Recife school hospitals, Pernambuco. Patients included will be allocated randomly into two groups. The first group will use misoprostol in the dosage of 200mcg and the second, will use the dosage of 800mcg. Administration, via the vaginal route, will occur 12 hours before performing the operative hysteroscopy. The following variables will be studied: cervical canal width, cervical length, degree of difficulty, duration and failure of cervical dilation, side effects, surgical complications and patient's satisfaction. For statistical analysis, chi-square tests of association, Fisher's exact and Mann-Whitney tests will be used to compare the groups, with an alpha error of less than 5% being considered significant.

Ethical aspects: This study will comply with Resolution 466/12 of the National Health Council and was submitted to and approved by the Professor Fernando Figueira Integral Medicine Institute Research Ethics Committee, beginning only after this approval. All participants will only be included if they voluntarily agree to participate by signing the Free and Informed Consent Form.

There are no conflicts of interest.

Eligibility criteria: Inclusion Criteria:

* Patients with indication for operative hysteroscopic.

Exclusion Criteria:

* Patient with contraindications to the use of prostaglandins such as asthma, glaucoma, renal failure, severe heart disease or drug allergy;
* Situations that impede the vaginal administration of medication such as major genital prolapse and virginity;
* Situations that prevent hysteroscopy as major uterine bleeding, diagnosis or suspected topical pregnancy and genital infection such as vaginosis and cervicitis;
* Situations that may influence cervical canal width such as a history of isthmo-cervical incompetence or major cervical surgery like conization or trachelotomy; presence of any structure like uterine fibroid or endometrial polyp inside the cervical canal or though the cervical os; patients on systemic or vaginal estrogen replacement therapy or who have recently used gonadotropin hormone-releasing hormone analogues.

Primary outcomes:
measure: Cervical canal width.
timeFrame: during the surgery
Secondary outcomes:
measure: Time required to dilate the cervix to 9mm.
timeFrame: during the surgery
measure: Ease of cervical dilation.
timeFrame: during the surgery
measure: Length of the cervix.
timeFrame: during the surgery
measure: Abandonment of the procedure due to cervical dilation failure.
timeFrame: during the surgery
measure: Intraoperative complications.
timeFrame: during the surgery
measure: Side effects due to the use of the misoprostol.
timeFrame: 24 hours
measure: Pain intensity
timeFrame: 24 hours
measure: Patient satisfaction degree.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Maria da Conceição Souto Maior
state: PE
Study officials:
affiliation: Instituto Materno Infantil Prof. Fernando Figueira
name: Aurélio Costa, PhD
role: STUDY_DIRECTOR
References:
citation: 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.