Clinical trial NCT01862991: Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services
Official title: Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Legally Induced Abortion Without Mention of Complication
Keywords: Induced Abortion
Mifepristone
Dilation and Evacuation
Cervical Preparation
Osmotic Dilators
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Medical Center
First posted: 2013-05-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Procedure Time
timeFrame: Intraoperative Time, Collected immediately within procedure
Secondary outcomes:
measure: Adverse Events
timeFrame: Intraoperatively and 2 weeks post operatively
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References: