Dose Comparison of Misoprostol for Cervix Ripening Before Operative Hysteroscopy.

NCT04152317 | Completed Phase 3

• 1 other identifier: MISO.
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix; Open

Keywords

Operative Hysteroscopy; Misoprostol

Outcome Measures

Primary Outcomes (1)

• Cervical canal width.

  Maximum size of dilator that passes through the internal os without resistance.

  during the surgery

Secondary Outcomes (8)

• 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

Study Arms (2)

Misoprostol 200mcg

EXPERIMENTAL

In this group, the participants will receive 200mcg of misoprostol, single dose, via the vaginal route.

Drug: Misoprostol 200mcg Tab

Misoprostol 800mcg

ACTIVE COMPARATOR

In this group, the participants will receive 800mcg of misoprostol, single dose, via the vaginal route.

Drug: Misoprostol 800mcg Tab

Interventions

Misoprostol 200mcg Tab DRUG

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.

Also known as: synthetic prostaglandin

Misoprostol 200mcg

Misoprostol 800mcg Tab DRUG

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.

Also known as: synthetic prostaglandin

Misoprostol 800mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indication for operative hysteroscopic.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Study Sites (1)

Maria da Conceição Souto Maior

Recife, Pernambuco, 52.050-020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34695232 DERIVED

MeSH Terms

Conditions

Uterine Cervical Incompetence

Interventions

Misoprostol; Prostaglandins, Synthetic

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Aurélio Costa, PhD

  Instituto Materno Infantil Prof. Fernando Figueira

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Degree

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 5, 2019
• Study Start: November 7, 2019
• Primary Completion: September 11, 2020
• Study Completion: September 12, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)