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

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: Female

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) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Misoprostol

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.