Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks (SAMi)

Boston University

Status: Completed

Conditions: Abortion

Treatments: Device: osmotic dilator insertion; Drug: mifepristone 200 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00986921

SAMi

Details and patient eligibility

About

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion criteria

• multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

mifepristone

Experimental group

Description:

women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed.

Treatment:

Drug: mifepristone 200 mg

Osmotic dilator insertion

Active Comparator group

Description:

Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure

Treatment:

Device: osmotic dilator insertion