Trial Outcomes & Findings for Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion (NCT NCT01085825)

Results Overview

Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

500 participants

Primary outcome timeframe

2 weeks - 6 months

Results posted on

2017-02-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Manual Vacuum Aspiration D \& C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.	Electric Vacuum Aspiration D \& C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
Overall Study STARTED	252	248
Overall Study COMPLETED	251	247
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Manual Vacuum Aspiration n=252 Participants D \& C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.	Electric Vacuum Aspiration n=248 Participants D \& C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.	Total n=500 Participants Total of all reporting groups
Age, Continuous	25.3 years STANDARD_DEVIATION 5 • n=99 Participants	25.4 years STANDARD_DEVIATION 5 • n=107 Participants	25.4 years STANDARD_DEVIATION 5 • n=206 Participants
Gender Female	252 Participants n=99 Participants	248 Participants n=107 Participants	500 Participants n=206 Participants
Gender Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Mean sac diameter	8.0 mm STANDARD_DEVIATION 2.4 • n=99 Participants	7.8 mm STANDARD_DEVIATION 2.3 • n=107 Participants	7.9 mm STANDARD_DEVIATION 2.3 • n=206 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Manual Vacuum Aspiration n=251 Participants D \& C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.	Electric Vacuum Aspiration n=247 Participants D \& C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
Accurate Confirmation of Completed Abortion	182 participants	164 participants

Adverse Events

Manual Vacuum Aspiration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electric Vacuum Aspiration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Director

Planned Parenthood of NYC

Phone: 212-274-7255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place