Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

Legally Induced Abortion Without Mention of Complication Clinical Trial

— POEM  

Official title:

Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862991
• Other study ID #: SU-05132013-108659
• Secondary ID: PF-108666
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• Viable, Singleton pregnancy

• Voluntarily seeking abortion between 19 and 24 wks gestation

• Able to give informed consent and comply with study protocol

• Fluent in English or Spanish

Exclusion Criteria:

• Allergy to misoprostol or mifepristone

Related Conditions & MeSH terms

• Legally Induced Abortion Without Mention of Complication

Intervention

Other:
• Hygroscopic cervical dilators
Dilapan-S osmotic cervical dilators inserted through the internal os.

Drug:
• Misoprostol
400 mcg buccal misoprostol 90 pre-op
• Intra-amniotic digoxin
1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
• Mifepristone
200 mcg Mifepristone orally

Locations

Country	Name	City	State
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Santa Clara Valley Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Time	Measured as time from speculum insertion to removal	Intraoperative Time, Collected immediately within procedure
Secondary	Adverse Events	Uterine perforation	Intraoperatively and 2 weeks post operatively