Induced Abortion
Conditions
Brief summary
A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.
Detailed description
Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.
Interventions
DRUGMifepristone
Progesterone antagonist
DRUGMisoprostol
Prostaglandin E1
DIETARY_SUPPLEMENTPlacebo
Tasteless, odorless, sugar based pill
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy women * eligible for non---urgent D&E * 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram
Exclusion criteria
* emergent need for D&E * fetal demise * intolerance * allergy or contraindication to mifepristone or misoprostol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Cervical Dilation | Assessed 4-6 hour following medications at time of D&E procedure | Initial cervical dilation as measured by Hegar Dilator accepted with least resistance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | intraoperative | 5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mifepristone Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
Mifepristone: Progesterone antagonist
Misoprostol: Prostaglandin E1 | 50 |
| Placebo Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Misoprostol: Prostaglandin E1
Placebo: Tasteless, odorless, sugar based pill | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Expulsion | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Mifepristone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Sex/Gender, Customized Female | 50 Participants | 50 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Initial Cervical Dilation
Initial cervical dilation as measured by Hegar Dilator accepted with least resistance
Time frame: Assessed 4-6 hour following medications at time of D&E procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mifepristone | Initial Cervical Dilation | 11.7 mm |
| Placebo | Initial Cervical Dilation | 10.9 mm |
Secondary
Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)
5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mifepristone | Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | Nausea | 4 units on a scale |
| Mifepristone | Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | Severe Cramps | 4 units on a scale |
| Placebo | Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | Nausea | 4 units on a scale |
| Placebo | Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | Severe Cramps | 4 units on a scale |