Abortion
Conditions
Keywords
Length of time for procedure to be completed, Need for additional dilation, Subject satisfaction with procedure
Brief summary
Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.
Interventions
mifepristone would be given the day before the procedure
osmotic dilators (3-6) would be inserted as usual the day before 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 45 Years
Healthy volunteers
No
Inclusion criteria
* women aged 18-45 having pregnancy termination at 14-16 weeks
Exclusion criteria
* multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for Completion of Procedure | Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment. | Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Ease of Procedure by Operator | It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point. | The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult. |
| Moderate or Severe Pain Overnight | Overnight | Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure) |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the abortion clinic, after they had already consented to the abortion procedure, October 2009 to March 2011.
Pre-assignment details
All women enrolled were assigned to groups. Group assignment was done very shortly after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Standard Osmotic Dilators Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique. | 25 |
| Mifepristone Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
Mifepristone 200 mg : mifepristone would be given the day before the procedure
All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Mifepristone | Total | Standard Osmotic Dilators |
|---|---|---|---|
| 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 | 25 Participants | 50 Participants | 25 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 5 | 25 years STANDARD_DEVIATION 4 | 25 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 25 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 | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Time for Completion of Procedure
Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)
Time frame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.
Population: Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Osmotic Dilators | Time for Completion of Procedure | 8.0 Minutes |
| Mifepristone | Time for Completion of Procedure | 9.87 Minutes |
p-value: 0.0595% CI: [0, 3]t-test, 1 sided
Secondary
Assessment of Ease of Procedure by Operator
The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult.
Time frame: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.
Population: All participants with a completed abortion procedure were rated by the operator as to ease of completing the procedure. The number of women in each group having an abortion procedure rated easy or very easy is tabulated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Osmotic Dilators | Assessment of Ease of Procedure by Operator | 46 percentage of participants |
| Mifepristone | Assessment of Ease of Procedure by Operator | 36 percentage of participants |
Comparison: The null hypothesis was that the groups would vary, with a p values of less than 0.05.p-value: 0.49Chi-squared
Secondary
Moderate or Severe Pain Overnight
Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)
Time frame: Overnight
Population: All participants are included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Osmotic Dilators | Moderate or Severe Pain Overnight | 52 percentage of participants |
| Mifepristone | Moderate or Severe Pain Overnight | 8 percentage of participants |
p-value: 0.001Chi-squared