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N/A N=80 Randomized Quadruple-blind Treatment

Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

Legally Induced Abortion Without Mention of Complication

Enrolled (actual)
80
Serious AEs
4.0%
Results posted
Jun 2017
Primary outcome: Primary: Procedure Time — 13; 12; 18.5 minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Hygroscopic cervical dilators (Other); Misoprostol (Drug); Intra-amniotic digoxin (Drug); Mifepristone (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Stanford University
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Procedure Time
13; 12; 18.5
SECONDARY
Adverse Events
0; 1; 2

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01862991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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