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Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage (MISO200)

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ClinicalTrials.gov Identifier: NCT02957305
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo Francalacci Savaris, Hospital de Clinicas de Porto Alegre

Brief Summary:
Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg). If cervical ripening is similar between these two regimens, costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

Condition or disease Intervention/treatment Phase
Miscarriage, Incomplete Drug: Misoprostol 400 µg Drug: Misoprostol 200 µg Phase 4

Detailed Description:

Miscarriage is defined by the World Health Organization as the interruption of the pregnancy up to 20-23 weeks, or the products of pregnancy weighting less than 500 grams (1). Nearly 15% of known pregnancies end in miscarriage, especially in the first 12 weeks. Estimates indicate that 68000 women die worldwide each year, as a result of unsafe abortions. Abortions are the major cause of maternal death, particularly in Latin America and the Caribbean. In cases of retained and incomplete abortions, uterine emptying is recommended. In the first trimester of pregnancy, either pharmacological or surgical procedure is accepted according to international guidelines.

Pharmacological treatment for uterine evacuation includes the administration of mifepristone and misoprostol or misoprostol alone. Nevertheless, surgical methods has been shown a greater acceptability and patient satisfaction due to a reduced incidence of adverse effects. Currently, Manual Intrauterine Aspiration (MIUA) is the technique recommended by the Brazilian Ministry of Health, and the Brazilian Federation of Gynecology and Obstetrics.

MIUA should be performed after cervical ripening. This pre-surgical procedure makes the procedure safer and more effective. In Brazil, misoprostol is the most suitable drug to be used in these cases because of its efficacy, easy of use, low cost, stability at room temperature and availability. Misoprostol is a synthetic prostaglandin E1 analogue and can be administered by oral, sublingual, buccal, rectal and vaginal routes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between 400 µg or 200 µg of Misoprostol for Cervical Dilatation in 1st Trimester Miscarriage - A Clinical Trial
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : December 21, 2020
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
Drug Information available for: Misoprostol

Arm Intervention/treatment
Active Comparator: Treatment A
Misoprostol 400 µg 3 hours before intrauterine suction
Drug: Misoprostol 400 µg
Evaluate the required cervix dilation in the moment of the intrauterne suction
Other Name: Misoprostol

Experimental: Treatment B
Misoprostol 200 µg 3 hours before intrauterine suction
Drug: Misoprostol 200 µg
Evaluate the required cervix dilation in the moment of the intrauterne suction
Other Name: Misoprostol




Primary Outcome Measures :
  1. Required cervix dilatation to appropriate intrauterine suction [ Time Frame: 1 year ]
    Cervical permeability (>= 8mm of dilation).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted at the Gynecological emergency Unit at Hospital de Clínicas de Porto Alegre scheduled for uterine evacuation with <12 weeks of gestation.

Exclusion Criteria:

  • patients who do not wish to participate in the project;
  • patients with ectopic pregnancy;
  • patients with comorbidities (heart failure congestive, chronic obstructive pulmonary disease);
  • patients with hypovolemic shock;
  • patients with cervical incompetence;
  • patients with infected miscarriage/abortion (presence of fever, pus from the cervix, leukocytosis [> 14000]);
  • patients with twin pregnancy;
  • patients with Marfan syndrome;
  • patients allergic to misoprostol;
  • patients with coagulopathy;
  • patients with opening of cervical internal os (4 mm of dilatation at the time of consultation);
  • patients with previous surgery of the cervix (conization);
  • patients with concomitant use of IUDs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957305


Contacts
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Contact: Ricardo F Ricardo, MD, PhD rsavaris@hcpa.edu.br

Locations
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Brazil
HCPA Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: RICARDO SAVARIS, PHD       rsavaris@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ricardo F Ricardo, MD, PhD HCPA

Publications of Results:

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Responsible Party: Ricardo Francalacci Savaris, Head of the Gynecologic Emergency Unit, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02957305     History of Changes
Other Study ID Numbers: 160309
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ricardo Francalacci Savaris, Hospital de Clinicas de Porto Alegre:
misoprostol
miscarriage
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics