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NCT01862991 · ClinicalTrials.gov registry record · NA
Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services
A NA study of Legally Induced Abortion Without Mention of Complication, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT01862991 is a NA study of Legally Induced Abortion Without Mention of Complication that has completed, run by Stanford University. The registered enrollment target is 80 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT01862991, a NA study of Legally Induced Abortion Without Mention of Complication, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Mifepristone
- DRUG Misoprostol
- OTHER Hygroscopic cervical dilators
- DRUG Intra-amniotic digoxin
Study Locations (2)
California
- Santa Clara Valley Medical Center - San Jose
- Stanford University Medical Center - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01862991
The ClinicalTrials.gov registry entry for NCT01862991 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Legally Induced Abortion Without Mention of Complication appearing as the primary indexed condition, and to 4 interventions - of which Mifepristone is the first listed.
NCT01862991 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01862991 about?
NCT01862991 is a clinical study titled "Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services". 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 ...
What is the current status of trial NCT01862991?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2013-07. Estimated completion is 2016-06.
What conditions does trial NCT01862991 study?
This clinical trial studies the following conditions: Legally Induced Abortion Without Mention of Complication.
What interventions are being tested in trial NCT01862991?
The interventions under investigation include: Mifepristone (DRUG), Misoprostol (DRUG), Hygroscopic cervical dilators (OTHER), Intra-amniotic digoxin (DRUG).
Who is sponsoring clinical trial NCT01862991?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01862991 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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