Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services
Public ClinicalTrials.gov record NCT01862991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01862991
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 80 participants
Conditions and interventions
Interventions
- Hygroscopic cervical dilators Other
- Misoprostol Drug
- Intra-amniotic digoxin Drug
- Mifepristone Drug
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2013
- Primary completion
- May 31, 2016
- Completion
- May 31, 2016
- Last update posted
- Feb 13, 2024
2013 – 2016
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Santa Clara Valley Medical Center | San Jose | California | 95128 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01862991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 13, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01862991 live on ClinicalTrials.gov.