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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-21

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Miscarriage in First Trimester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Patients, operators and statistical analysis were performed blindly.

Study Groups

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Misoprostol 400 µg

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.

Group Type ACTIVE_COMPARATOR

Misoprostol 400mcg Tab

Intervention Type DRUG

400µg of misoprostol (2 tablets)

Misoprostol 200 µg

Participants received misoprostol 200 µg: 1 tablet of misoprostol introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure.

Group Type EXPERIMENTAL

Misoprostol 200mcg Tab

Intervention Type DRUG

200µg of misoprostol (1 tablet)

Interventions

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Misoprostol 400mcg Tab

400µg of misoprostol (2 tablets)

Intervention Type DRUG

Misoprostol 200mcg Tab

200µg of misoprostol (1 tablet)

Intervention Type DRUG

Other Intervention Names

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Misoprostol control Misoprostol comparator

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No