Induced Abortion
Conditions
Keywords
induced abortion, termination of pregnancy, manual vacuum aspiration, electric vacuum aspiration
Brief summary
With sensitive urine pregnancy tests, women are now able to confirm very early pregnancies. However, approximately one third of abortion facilities do not offer abortions at less than six weeks of pregnancy. Providers may be concerned that they will be unable to identify products of conception (POCs) in uterine aspirates after early abortion and about the time, cost and risk associated with following serum hCG levels when completed abortion cannot be confirmed by gross inspection. Many providers believe that manual vacuum aspiration (MVA) causes less destruction of pregnancy tissue and therefore may increase the likelihood of identifying POCs on gross inspection. No published reports specifically compare MVA to electric vacuum aspiration (EVA) for the detection of complete products of conception and none compare MVA and EVA at less than 6 weeks of pregnancy. We, the investigators, propose to conduct a randomized controlled trial comparing the sensitivity of MVA to EVA for the detection of completed abortion in 500 women with pregnancies of less than 6 weeks gestation at a large inner city family planning center. We will measure positive identification of POCs on gross inspection in patients subsequently shown to have completed abortions. We hypothesize that the rate of true positive detection of POCs will be higher in dilation and curettage (D&C) using MVA than EVA.
Interventions
PROCEDURED & C abortion
Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
Sponsors
Society of Family Planning
Planned Parenthood of Greater New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* gestational sac size \<12 mm or no visible sac (with positive pregnancy test) day of surgical abortion * no medical contraindications to outpatient abortion at study site
Exclusion criteria
* not able to consent * suspected ectopic pregnancy (pelvic mass, unilateral pain, or detection on ultrasound), suspected molar pregnancy, or no sac and vaginal bleeding suspicious for completed spontaneous abortion * failed medication abortion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accurate Confirmation of Completed Abortion | 2 weeks - 6 months | Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses |
Countries
United States
Participant flow
Recruitment details
We enrolled a total of 500 women from April 22, 2010 to October 14, 2011; 252 women were randomized to MVA and 248 to EVA.
Participants by arm
| Arm | Count |
|---|---|
| Manual Vacuum Aspiration D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. | 252 |
| Electric Vacuum Aspiration D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration. | 248 |
| Total | 500 |
Baseline characteristics
| Characteristic | Manual Vacuum Aspiration | Electric Vacuum Aspiration | Total |
|---|---|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 5 | 25.4 years STANDARD_DEVIATION 5 | 25.4 years STANDARD_DEVIATION 5 |
| Gender Female | 252 Participants | 248 Participants | 500 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Mean sac diameter | 8.0 mm STANDARD_DEVIATION 2.4 | 7.8 mm STANDARD_DEVIATION 2.3 | 7.9 mm STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 252 | 0 / 248 |
| serious Total, serious adverse events | 0 / 252 | 0 / 248 |
Outcome results
Primary
Accurate Confirmation of Completed Abortion
Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses
Time frame: 2 weeks - 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Vacuum Aspiration | Accurate Confirmation of Completed Abortion | 182 participants |
| Electric Vacuum Aspiration | Accurate Confirmation of Completed Abortion | 164 participants |
p-value: 0.13Chi-squared