Legally Induced Abortion Without Mention of Complication
Conditions
Keywords
Induced Abortion, Mifepristone, Dilation and Evacuation, Cervical Preparation, Osmotic Dilators
Brief 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.
Interventions
Dilapan-S osmotic cervical dilators inserted through the internal os.
DRUGMisoprostol
400 mcg buccal misoprostol 90 pre-op
1mg digoxin administered intra-amniotically \ 24 hours pre-op in patients that are greater than 22 weeks gestation
DRUGMifepristone
200 mcg Mifepristone orally
Sponsors
Santa Clara Valley Medical Center
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | Intraoperative Time, Collected immediately within procedure | Measured as time from speculum insertion to removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Intraoperatively and 2 weeks post operatively | Uterine perforation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dilapan-Placebo The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \
24 hours pre-op in patients that are greater than 22 weeks gestation | 21 |
| Dilapan-Mifepristone The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \
24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally | 27 |
| Mifepristone The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.
Misoprostol: 400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically \
24 hours pre-op in patients that are greater than 22 weeks gestation
Mifepristone: 200 mcg Mifepristone orally | 27 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Dilapan-Placebo | Dilapan-Mifepristone | Mifepristone | Total |
|---|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 7 | 27.5 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 6 | 28 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment United States | 21 participants | 27 participants | 27 participants | 75 participants |
| Sex: Female, Male Female | 21 Participants | 27 Participants | 27 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 21 | 0 / 27 | 5 / 27 |
| serious Total, serious adverse events | 0 / 21 | 1 / 27 | 2 / 27 |
Outcome results
Primary
Procedure Time
Measured as time from speculum insertion to removal
Time frame: Intraoperative Time, Collected immediately within procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dilapan-Placebo | Procedure Time | 13 minutes |
| Dilapan-Mifepristone | Procedure Time | 12 minutes |
| Mifepristone | Procedure Time | 18.5 minutes |
Secondary
Adverse Events
Uterine perforation
Time frame: Intraoperatively and 2 weeks post operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dilapan-Placebo | Adverse Events | 0 Participants |
| Dilapan-Mifepristone | Adverse Events | 1 Participants |
| Mifepristone | Adverse Events | 2 Participants |