Phase 3
Completed N=50
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Cervical Preparation
Source: ClinicalTrials.gov NCT01436279 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Length of Procedure — 14; 13.5 minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Procedure |
14; 13.5 | — |
| SECONDARY Operative Time |
9; 8.5 | — |
| SECONDARY Subject Discomfort Before the Abortion |
18; 7; 7; 6; 5; 3 | — |
| SECONDARY Pain Medication (Fentanyl) During the Abortion |
3.1; 2.9 | — |
| SECONDARY Pain Medication (Midazolam) During the Abortion |
104; 105 | — |
| SECONDARY Cervical Dilation Achieved |
42; 56 | — |
| SECONDARY Acceptability to Patient |
26; 11 | — |
| SECONDARY Difficulty of Procedure |
5; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Women 18-50 years of age undergoing surgical termination of pregnancy
- English or Spanish speaking
- Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
- Eligible for a dilation and evacuation abortion with local anesthesia and sedation
- Ultrasound for dating purposes done within the last two weeks
Exclusion Criteria
- Intrauterine infection
- Fetal demise
- Ruptured membranes
- Multiple gestation
- Uterine anomaly or significant distortion of the uterus with fibroids
- BMI greater than 45
- Inability to place osmotic dilators
- Active substance abuse or intoxication
- Adrenal failure, chronic corticosteroid use, anticoagulant usage
- Severe cervicitis, until treated and resolved
- Prior Cesarean section
Data sourced from ClinicalTrials.gov (NCT01436279). 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.