Cervical Preparation
Conditions
Brief 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.
Interventions
DRUGMifepristone
200 mg po 20-24 hours prior to the procedure
DEVICEosmotic dilators
osmotic dilators placed in the cervix 20-24 hours prior to the procedure
Sponsors
Society of Family Planning
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Procedure | Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days. | Interval from speculum insertion to speculum removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Discomfort Before the Abortion | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe |
| Pain Medication (Fentanyl) During the Abortion | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | Amount of pain medication used during the procedure: reported as micrograms of fentanyl |
| Pain Medication (Midazolam) During the Abortion | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | Amount of pain medication used during the procedure: reported as milligrams of midazolam |
| Operative Time | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | Interval from initiation of vacuum aspiration to speculum removal |
| Acceptability to Patient | After procedure completion | Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was yes is being reported. |
| Difficulty of Procedure | After completion of procedure | Outcome measure is the number and percentage of participants where the provider rated the procedure as difficult or very difficult. Provider assessment of difficulty of procedure categories were: very easy, easy, moderate, difficult, or very difficult. |
| Cervical Dilation Achieved | At time of abortion | Cervical dilation at start of procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mifepristone + Misoprostol Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure | 30 |
| Osmotic Dilators Placed 20-24 hours prior to procedure | 20 |
| Total | 50 |
Baseline characteristics
| Characteristic | Mifepristone + Misoprostol | Osmotic Dilators | 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 | 30 Participants | 20 Participants | 50 Participants |
| Sex: Female, Male Female | 30 Participants | 20 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 20 |
| other Total, other adverse events | 0 / 30 | 0 / 20 |
| serious Total, serious adverse events | 0 / 30 | 0 / 20 |
Outcome results
Primary
Length of Procedure
Interval from speculum insertion to speculum removal
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mifepristone + Misoprostol | Length of Procedure | 14 minutes |
| Osmotic Dilators | Length of Procedure | 13.5 minutes |
Secondary
Acceptability to Patient
Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was yes is being reported.
Time frame: After procedure completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone + Misoprostol | Acceptability to Patient | 26 Participants |
| Osmotic Dilators | Acceptability to Patient | 11 Participants |
Secondary
Cervical Dilation Achieved
Cervical dilation at start of procedure
Time frame: At time of abortion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mifepristone + Misoprostol | Cervical Dilation Achieved | 42 mm | Standard Deviation 11 |
| Osmotic Dilators | Cervical Dilation Achieved | 56 mm | Standard Deviation 5 |
Secondary
Difficulty of Procedure
Outcome measure is the number and percentage of participants where the provider rated the procedure as difficult or very difficult. Provider assessment of difficulty of procedure categories were: very easy, easy, moderate, difficult, or very difficult.
Time frame: After completion of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone + Misoprostol | Difficulty of Procedure | 5 Participants |
| Osmotic Dilators | Difficulty of Procedure | 3 Participants |
Secondary
Operative Time
Interval from initiation of vacuum aspiration to speculum removal
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mifepristone + Misoprostol | Operative Time | 9 minutes |
| Osmotic Dilators | Operative Time | 8.5 minutes |
Secondary
Pain Medication (Fentanyl) During the Abortion
Amount of pain medication used during the procedure: reported as micrograms of fentanyl
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mifepristone + Misoprostol | Pain Medication (Fentanyl) During the Abortion | 3.1 mcg | Standard Deviation 1.34 |
| Osmotic Dilators | Pain Medication (Fentanyl) During the Abortion | 2.9 mcg | Standard Deviation 1 |
Secondary
Pain Medication (Midazolam) During the Abortion
Amount of pain medication used during the procedure: reported as milligrams of midazolam
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mifepristone + Misoprostol | Pain Medication (Midazolam) During the Abortion | 104 mg | Standard Deviation 31 |
| Osmotic Dilators | Pain Medication (Midazolam) During the Abortion | 105 mg | Standard Deviation 26 |
Secondary
Subject Discomfort Before the Abortion
Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mifepristone + Misoprostol | Subject Discomfort Before the Abortion | None | 18 participants |
| Mifepristone + Misoprostol | Subject Discomfort Before the Abortion | Mild | 7 participants |
| Mifepristone + Misoprostol | Subject Discomfort Before the Abortion | Moderate | 5 participants |
| Mifepristone + Misoprostol | Subject Discomfort Before the Abortion | Severe | 0 participants |
| Osmotic Dilators | Subject Discomfort Before the Abortion | Severe | 4 participants |
| Osmotic Dilators | Subject Discomfort Before the Abortion | None | 7 participants |
| Osmotic Dilators | Subject Discomfort Before the Abortion | Moderate | 3 participants |
| Osmotic Dilators | Subject Discomfort Before the Abortion | Mild | 6 participants |