Trial Outcomes & Findings for 'Levonorgestrel IUD Insertion After D&E Procedure (NCT NCT00475228)

Results Overview

To assess the six-month usage rate of the LNG-IUD when placed immediately after D\&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D\&E. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D\&E procedure than women receiving delayed insertion.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

93 participants

Primary outcome timeframe

6 months

Results posted on

2017-05-09

Participant Flow

Women undergoing D\&E at 15 to 23 weeks of gestation were approached for enrollment. After completion of the D\&E, women who consented were enrolled as long as there no contraindications to immediate IUD insertion. 88 out of the 93 subjects were randomized to either Arm I (immediate) or Arm 2 (delayed, 3 to 6 weeks later LNG-IUD insertion).

Participant milestones

Participant milestones
Measure	Arm I: Immediate LNG-IUD Insertion Group Levonorgestrel IUD will be inserted immediately after completion of D\&E Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem	Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem
Overall Study STARTED	44	44
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	17	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I: Immediate LNG-IUD Insertion Group Levonorgestrel IUD will be inserted immediately after completion of D\&E Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem	Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem
Overall Study Lost to Follow-up	17	17

Baseline Characteristics

'Levonorgestrel IUD Insertion After D&E Procedure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I: Immediate LNG-IUD Insertion Group n=44 Participants Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D\& E	Arm 2: Delayed LNG-IUD Insertion Group n=44 Participants Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.	Total n=88 Participants Total of all reporting groups
Age, Customized at least 18 years of age	44 participants n=5 Participants	44 participants n=7 Participants	88 participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Attempts to contact all participants (Arm 1: 44 women and Arm 2: 44 women) by phone 6 months post D\&E were made. For Arm 1, 27 out of 44 women could be reached. For Arm 2; 27 out of the 44 were reached (19 women who returned and had the LNG-IUD placed 3-6 weeks post D\&E and 8 women who did not return for the LNG-IUD placement 3-6 post D\&E).

To assess the six-month usage rate of the LNG-IUD when placed immediately after D\&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D\&E. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D\&E procedure than women receiving delayed insertion.

Outcome measures

Outcome measures
Measure	Arm I: Immediate LNG-IUD Insertion Group n=27 Participants Levonorgestrel IUD will be inserted immediately after completion of D\&E Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem	Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group n=27 Participants Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem
The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.	85.2 percentage of participants Interval 66.3 to 95.8	62.9 percentage of participants Interval 42.4 to 80.6

SECONDARY outcome

Timeframe: 2 Months

Population: In Arm 1, all 44 participants were inserted with an LNG-IUD immediately post D\& E successfully. In Arm 2; only 20 of the 44 participants returned and had the LNG-IUD inserted successfully 3 to 6 weeks post D\&E.

The difference between the overall number of women who had the LNG-IUD inserted immediately post D\&E successfully (Arm 1) was compared to the overall number of women who had the LNG-IUD inserted 3 -6 weeks post D\&E (standard or routine) (Arm 2).

Outcome measures

Outcome measures
Measure	Arm I: Immediate LNG-IUD Insertion Group n=20 Completed LNG-IUD Insertions Levonorgestrel IUD will be inserted immediately after completion of D\&E Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem	Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group n=44 Completed LNG-IUD Insertions Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem
To Examine the Number of Women Receiving the LNG-IUD in Each Group	20 Completed LNG-IUD Insertions	44 Completed LNG-IUD Insertions

SECONDARY outcome

Timeframe: 6 months

Population: 3 of the 44 participants who had the LNG-IUD placed in Arm 1 underwent an IUD expulsion. 1 of the 20 participants who had the LNG-IUD placed in Arm 2 underwent an IUD expulsion.

Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group

Outcome measures

Outcome measures
Measure	Arm I: Immediate LNG-IUD Insertion Group n=44 Participants Levonorgestrel IUD will be inserted immediately after completion of D\&E Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem	Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group n=20 Participants Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem
To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion	6.8 percentage of participants	5.0 percentage of participants

Adverse Events

Arm I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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

Heather Hohmann, MD

University o Pittsburgh

Phone: 412-641-1441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place