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

Phase 4

Completed

Conditions: Miscarriage in First Trimester

Interventions: Drug: Misoprostol 200mcg Tab
Drug: Misoprostol 400mcg Tab

Registration Number: NCT02957305

Lead Sponsor: 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) 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.

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 weighing 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 have been shown a greater acceptability and patient satisfaction due to a reduced incidence of adverse effects. Currently, Manual Vacuum Aspiration (MVA) is the technique recommended by the Brazilian Ministry of Health and the Brazilian Federation of Gynecology and Obstetrics.

MVA 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, ease of use, low cost, stability at room temperature, and availability. Misoprostol is a synthetic prostaglandin E1 analog and can be administered by oral, sublingual, buccal, rectal, and vaginal routes.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 211

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol 200 µg	Misoprostol 200mcg Tab	Participants received misoprostol 200 µg: 1 tablet of misoprostol introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure.
Misoprostol 400 µg	Misoprostol 400mcg Tab	Participants received misoprostol 400 µg: 2 tablets of misoprostol (200µg each) introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration (MVA) procedure.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration	baseline at initiation of the Manual Vacuum Aspiration	this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation	Baseline before Manual Vacuum Aspiration procedure	This outcome measures how many mm of dilation the cervical canal has before the procedure. Cervical permeability (≥8 mm of dilation, used as a cut-off) was measured using Karman cannulas, from higher to low diameter.