Trial Outcomes & Findings for Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion (NCT NCT00737178)

Results Overview

Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

156 participants

Primary outcome timeframe

6 months

Results posted on

2014-09-19

Participant Flow

Women presenting to Columbia University's Special Gynecology Services for medication abortion will receive comprehensive contraceptive counseling. Those interested in the Intrauterine Device (IUD) for contraception will be offered study participation. Those who accept enrollment in the study and sign consent will be randomized into 1 of 2 groups.

For both groups, the routine 1 week follow-up visit will confirm a successful medication abortion by passage of gestational sac on sonogram. Endometrial stripe thickness will be also be noted. For both groups a transvaginal sonogram will be performed immediately after IUD insertion to confirm IUD position.

Participant milestones

Participant milestones
Measure	Immediate IUD Insertion IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion	Delayed IUD Insertion IUD insertion four to six weeks after initiation of a medication abortion
Overall Study STARTED	71	85
Overall Study COMPLETED	66	76
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate IUD Insertion n=71 Participants IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion	Delayed IUD Insertion n=85 Participants IUD insertion four to six weeks after initiation of a medication abortion	Total n=156 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants	85 Participants n=7 Participants	156 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	85 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants	85 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).

Outcome measures

Outcome measures
Measure	Immediate IUD Insertion n=71 Participants IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion	Delayed IUD Insertion n=85 Participants IUD insertion four to six weeks after initiation of a medication abortion
Use of the IUD for Contraception at Six Months	49 participants	51 participants

SECONDARY outcome

Timeframe: By six months after medication abortion

Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.

Outcome measures

Outcome measures
Measure	Immediate IUD Insertion n=71 Participants IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion	Delayed IUD Insertion n=85 Participants IUD insertion four to six weeks after initiation of a medication abortion
Insertion Rates	69 participants	65 participants

SECONDARY outcome

Timeframe: Within six months of medication abortion

Population: Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion

Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study. Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study.

Outcome measures

Outcome measures
Measure	Immediate IUD Insertion n=69 Participants IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion	Delayed IUD Insertion n=65 Participants IUD insertion four to six weeks after initiation of a medication abortion
Expulsion and Removal Rates Expulsions	8 participants	7 participants
Expulsion and Removal Rates Removals	10 participants	5 participants

Adverse Events

Immediate IUD Insertion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed IUD Insertion

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

Anne Davis, MD

Columbia University

Phone: 2123054951

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place