Abortion, Induced
Conditions
Keywords
abortion, induced
Brief summary
The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion. * Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix * Osmotic dilators plus mifepristone, a medicine that is swallowed * Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum Hypotheses: * adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer. * adding oral mifepristone at the time of laminaria placement will confer a similar benefit. * the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents. * significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences. * patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.
Interventions
OTHERMifepristone
oral mifepristone 200 mg on Day 1.
DRUGmisoprostol
buccal misoprostol 400 mcg on Day 2
DEVICEOsmotic dilators
osmotic dilators on Day 1
OTHERplacebo
placebo for mifepristone, on day 1
Sponsors
Society of Family Planning
Planned Parenthood League of Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years and older * Able to give informed consent * Medically eligible for outpatient second trimester pregnancy termination at the clinical site * English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish
Exclusion criteria
* Active bleeding (\>1 pad/hour) or hemodynamically unstable at enrollment * Signs of chorioamnionitis or clinical infection at enrollment * Signs of spontaneous labor or cervical insufficiency at enrollment * Spontaneous intrauterine fetal demise * Patient incarcerated * Allergy to mifepristone or misoprostol * Chronic steroid use or adrenal insufficiency * Porphyria * Inflammatory bowel disease requiring treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | participants were assessed for the duration of the procedure, an average of 6 minutes | The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Complete the D&E on the First Attempt | participants were assessed for the duration of the procedure, an average of 6 minutes | Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day. |
| Need for Mechanical Dilation | participants were assessed for the duration of the procedure, an average of 6 minutes | Assessed on Day of procedure. Assessed immediately after completion of D&E |
| Ease of Mechanical Dilation | participants were assessed for the duration of the procedure, an average of 6 minutes | Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E |
| Initial Cervical Dilation | participants were assessed during cervical dilation process, average time of 1 minute | Measured at the time of procedure (immediately before the start of D&E) |
| Chills (Any) After Day 2 Medication Administration | assessed immediately after administration of day 2 medication | chills (any) after Day 2 medication administration |
| Patient Satisfaction With Cervical Prep | patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days | Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home. |
| Physician Satisfaction With Cervical Preparation | physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes | Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure. |
| Complications From Procedure | assessed immediately after completion of D&E and at 1 week and 1 month post-procedure | Patient having any complication, including hospitalizations transfusions additional unplanned procedures |
Countries
United States
Participant flow
Recruitment details
Recruitment period: February 2013-February 2014 Number of recruitment sites: 7 Types of location: medical clinic (3), hospital-based (4)
Participants by arm
| Arm | Count |
|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1
placebo: placebo for misoprostol, on day 2 | 100 |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol: buccal misoprostol 400 mcg on Day 2
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for mifepristone, on day 1 | 100 |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone: oral mifepristone 200 mg on Day 1.
Osmotic dilators: osmotic dilators on Day 1
placebo: placebo for misoprostol, on day 2 | 100 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Osmotic Dilators + Placebo (Vit c) + Misoprostol | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Total |
|---|---|---|---|---|
| Age, Continuous | 24.6 years STANDARD_DEVIATION 5.7 | 25.9 years STANDARD_DEVIATION 5.9 | 25.3 years STANDARD_DEVIATION 5.8 | 25.25 years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized African American or black | 39 participants | 48 participants | 36 participants | 123 participants |
| Race/Ethnicity, Customized Hispanic or Latina | 19 participants | 18 participants | 22 participants | 59 participants |
| Race/Ethnicity, Customized Other | 11 participants | 12 participants | 13 participants | 36 participants |
| Race/Ethnicity, Customized White or European American | 31 participants | 22 participants | 29 participants | 82 participants |
| Region of Enrollment United States | 100 participants | 100 participants | 100 participants | 300 participants |
| Sex: Female, Male Female | 100 Participants | 100 Participants | 100 Participants | 300 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 | 8 / 99 | 1 / 100 | 1 / 99 |
| serious Total, serious adverse events | 2 / 99 | 1 / 100 | 1 / 99 |
Outcome results
Primary
Operative Time
The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Population: Arm 1 (dilators-alone): 1 subject excluded \[withdrawn/no intervention\]. Arm 2 (dilators + misoprostol): 2 excluded: \[one expelled, no D\&E, one D\&E not completed on first attempt \& data missing\]. Arm 3 (dilators + mifepristone): 2 excluded (1 withdrawn/no intervention, 1 D\&E not completed on first attempt \& data missing\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Operative Time | 6.27 minutes | Standard Deviation 3.5 |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Operative Time | 6.28 minutes | Standard Deviation 4.6 |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Operative Time | 5.53 minutes | Standard Deviation 2.9 |
Secondary
Ability to Complete the D&E on the First Attempt
Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Ability to Complete the D&E on the First Attempt | 98 participants |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Ability to Complete the D&E on the First Attempt | 98 participants |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Ability to Complete the D&E on the First Attempt | 98 participants |
Secondary
Chills (Any) After Day 2 Medication Administration
chills (any) after Day 2 medication administration
Time frame: assessed immediately after administration of day 2 medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Chills (Any) After Day 2 Medication Administration | 12 participants |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Chills (Any) After Day 2 Medication Administration | 39 participants |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Chills (Any) After Day 2 Medication Administration | 18 participants |
Secondary
Complications From Procedure
Patient having any complication, including hospitalizations transfusions additional unplanned procedures
Time frame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Complications From Procedure | 10 participants |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Complications From Procedure | 2 participants |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Complications From Procedure | 2 participants |
Secondary
Ease of Mechanical Dilation
Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Population: Number of participants in each arm who required additional mechanical dilation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Ease of Mechanical Dilation | 6 participants |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Ease of Mechanical Dilation | 4 participants |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Ease of Mechanical Dilation | 1 participants |
Secondary
Initial Cervical Dilation
Measured at the time of procedure (immediately before the start of D&E)
Time frame: participants were assessed during cervical dilation process, average time of 1 minute
Population: Arm 1: 1 subject excluded \[withdrawn/no intervention\]. Arm 2: 2 excluded: \[one expelled, no D\&E, one D\&E not completed on first attempt \& data missing\]. Arm 3: 2 excluded (1 withdrawn/no intervention, 1 D\&E not completed on first attempt \& data missing\]. Additionally missing data for one more subject in Arm 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Initial Cervical Dilation | 2.2 centimeters | Standard Deviation 0.5 |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Initial Cervical Dilation | 2.5 centimeters | Standard Deviation 0.9 |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Initial Cervical Dilation | 2.4 centimeters | Standard Deviation 0.5 |
Secondary
Need for Mechanical Dilation
Assessed on Day of procedure. Assessed immediately after completion of D&E
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Population: Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D\&E. Arm 3: one subject withdrawn/no intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Need for Mechanical Dilation | 26 participants |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Need for Mechanical Dilation | 9 participants |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Need for Mechanical Dilation | 16 participants |
Secondary
Patient Satisfaction With Cervical Prep
Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.
Time frame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Patient Satisfaction With Cervical Prep | 72 participants |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Patient Satisfaction With Cervical Prep | 80 participants |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Patient Satisfaction With Cervical Prep | 80 participants |
Secondary
Physician Satisfaction With Cervical Preparation
Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.
Time frame: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
Population: Data on whether the physician was satisfied with the cervical preparation is available for all participants except:~Arm 1: 1 participant withdrawn with no intervention; Arm 2: 1 participant who didn't have a D\&E (expelled), Arm 3: 1 participant withdrawn with no intervention and one with missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Physician Satisfaction With Cervical Preparation | 71 participants |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol | Physician Satisfaction With Cervical Preparation | 78 participants |
| Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Physician Satisfaction With Cervical Preparation | 85 participants |