N/A
Completed N=50
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
Abortion, Induced
Source: ClinicalTrials.gov NCT01615731 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Procedure Time — 10.9; 11.8 minutes
Summary
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Time |
10.9; 11.8 | — |
| PRIMARY Total Procedure Time |
165; 86 | — |
| SECONDARY Maximum Cervical Dilation |
2; 3; 9; 14; 8; 5 | — |
| SECONDARY Adverse Events (EBL) |
57; 63 | — |
| SECONDARY Ease of Procedure by Blinded Surgeon |
29; 30 | — |
| SECONDARY Pain Perceived by Patient |
13; 63; 3; 16 | — |
| SECONDARY Overall Patient Experience |
72; 79 | — |
| SECONDARY Adverse Events |
2; 1; 0; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Exclusion Criteria
- Allergy to misoprostol or mifepristone
Data sourced from ClinicalTrials.gov (NCT01615731). 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. Informational only — not medical advice.