Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Cervical Preparation Clinical Trial

— SaMi2  

Official title:

Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436279
• Other study ID #: H-31032
• Secondary ID: AU 6003109
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2011
• Last updated: March 18, 2014
• Start date: July 2011
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort after mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women 18-50 years of age undergoing surgical termination of pregnancy

• English or Spanish speaking

• Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating

• Eligible for a dilation and evacuation abortion with local anesthesia and sedation

• Ultrasound for dating purposes done within the last two weeks

Exclusion Criteria:

• Intrauterine infection

• Fetal demise

• Ruptured membranes

• Multiple gestation

• Uterine anomaly or significant distortion of the uterus with fibroids

• BMI greater than 45

• Inability to place osmotic dilators

• Active substance abuse or intoxication

• Adrenal failure, chronic corticosteroid use, anticoagulant usage

• Severe cervicitis, until treated and resolved

• Prior Cesarean section

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Preparation

Intervention

Drug:
• Mifepristone
200 mg po 20-24 hours prior to the procedure

Device:
• osmotic dilators
osmotic dilators placed in the cervix 20-24 hours prior to the procedure

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of procedure	Interval from speculum insertion to speculum removal	Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.	No
Secondary	Operative time	Interval from initiation of vacuum aspiration to speculum removal	Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.	No
Secondary	Cervical dilation at the start of the procedure		Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.	No
Secondary	Patient opinions about the process		Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.	No
Secondary	Provider assessment of the procedure		Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.	No
Secondary	Subject discomfort during the abortion		Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.	No
Secondary	Subject discomfort after the abortion		Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.	No
Secondary	Subject discomfort before the abortion		Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.	No