Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services
POEM
Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services
2 other identifiers
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 27, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
June 1, 2017
CompletedFebruary 14, 2024
January 1, 2024
2.9 years
May 22, 2013
February 7, 2017
January 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedure Time
Measured as time from speculum insertion to removal
Intraoperative Time, Collected immediately within procedure
Secondary Outcomes (1)
Adverse Events
Intraoperatively and 2 weeks post operatively
Study Arms (3)
Dilapan-Placebo
PLACEBO COMPARATORThe clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Dilapan-Mifepristone
ACTIVE COMPARATORThe clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Mifepristone
EXPERIMENTALThe patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Interventions
Dilapan-S osmotic cervical dilators inserted through the internal os.
1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation
200 mcg Mifepristone orally
Eligibility Criteria
You may qualify if:
- \>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
You may not qualify if:
- Allergy to misoprostol or mifepristone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Santa Clara Valley Medical Centercollaborator
Study Sites (2)
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Stanford University Medical Center
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2013
First Posted
May 27, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
February 14, 2024
Results First Posted
June 1, 2017
Record last verified: 2024-01