Trial Outcomes & Findings for Insertion of an Intrauterine Device (IUD) After Medical Abortion (NCT NCT00621543)

NCT ID: NCT00621543

Last Updated: 2011-07-14

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Three months

Results posted on

2011-07-14

Participant Flow

Participant milestones

Participant milestones
Measure
Observation- All Subjects
Women choosing intra-uterine contraception after medical abortion.
Overall Study
STARTED
120
Overall Study
COMPLETED
97
Overall Study
NOT COMPLETED
23

Reasons for withdrawal

Reasons for withdrawal
Measure
Observation- All Subjects
Women choosing intra-uterine contraception after medical abortion.
Overall Study
Lost to Follow-up
23

Baseline Characteristics

Insertion of an Intrauterine Device (IUD) After Medical Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Observation- All Subjects
n=120 Participants
Women choosing intra-uterine contraception after medical abortion.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
120 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age Continuous
28 years
STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male
Female
120 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
120 participants
n=5 Participants

PRIMARY outcome

Timeframe: Three months

Outcome measures

Outcome measures
Measure
Single Arm Study
n=97 Participants
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
4 percentage of participants
Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure
Single Arm Study
n=97 Participants
Percentage of Women Continuing IUD Use at 3 Months
80. percentage of participants
Interval 74.0 to 86.0

Adverse Events

Observation- All Subjects

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

Sarah Betstadt, MD, MPH

University of Rochester

Phone: 585-276-5368

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place