Hygroscopic cervical dilators
OtherDilapan-S osmotic cervical dilators inserted through the internal os.
Other names: Dilapan-S
NCT Number: NCT01862991
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Santa Clara Valley Medical Center, San Jose, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dilapan-S osmotic cervical dilators inserted through the internal os.
Other names: Dilapan-S
400 mcg buccal misoprostol 90 pre-op
1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
200 mcg Mifepristone orally
Other names: Danco, Mifeprex
Time frame: Intraoperative Time, Collected immediately within procedure
Measured as time from speculum insertion to removal
Time frame: Intraoperatively and 2 weeks post operatively
Uterine perforation
Stanford University
Other
Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services
Acronym: POEM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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