N/A
N=50
Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks
Abortion
Bottom Line
View on ClinicalTrials.gov: NCT00986921 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Time for Completion of Procedure — 8.0; 9.87 Minutes — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mifepristone 200 mg (Drug); osmotic dilator insertion (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston University
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time for Completion of Procedure |
8.0; 9.87 | 0.05 |
| SECONDARY Assessment of Ease of Procedure by Operator |
46; 36 | 0.49 |
| SECONDARY Moderate or Severe Pain Overnight |
52; 8 | 0.001 sig |
Summary
Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.
Eligibility Criteria
Inclusion Criteria
- women aged 18-45 having pregnancy termination at 14-16 weeks
Exclusion Criteria
- multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
Data sourced from ClinicalTrials.gov (NCT00986921). 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.