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'Levonorgestrel IUD Insertion After D&E Procedure (ILIAD)

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ClinicalTrials.gov Identifier: NCT00475228
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Heather Hohmann, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Contraceptive Usage
Intervention Drug: Levonorgestrel IUD
Enrollment 93
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Arm I: Immediate LNG-IUD Insertion Group Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 44 44
Completed 27 27
Not Completed 17 17
Reason Not Completed
Lost to Follow-up             17             17
Arm/Group Title Arm I: Immediate LNG-IUD Insertion Group Arm 2: Delayed LNG-IUD Insertion Group Total
Hide Arm/Group Description Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice. Total of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
After completion of the D&E, 88 of the 93 women who consented were randomized 1:1 to Arm 1 and Arm 2.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
at least 18 years of age Number Analyzed 44 participants 44 participants 88 participants
44 44 88
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
44
 100.0%
44
 100.0%
88
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.
Hide Description

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.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Arm I: Immediate LNG-IUD Insertion Group Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 27 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.2
(66.3 to 95.8)
62.9
(42.4 to 80.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: Immediate LNG-IUD Insertion Group, Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title To Examine the Number of Women Receiving the LNG-IUD in Each Group
Hide Description 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).
Time Frame 2 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group Arm I: Immediate LNG-IUD Insertion Group
Hide Arm/Group Description:

Levonorgestrel IUD was inserted at standard time post-procedure (3-6 weeks post D&E procedure) in 20 participants. The remaining 24 women did not return 3-6 weeks after the D&E.

Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem

Levonorgestrel IUD was inserted immediately after completion of D&E in all 44 participants

Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem

Overall Number of Participants Analyzed 44 44
Overall Number of Units Analyzed
Type of Units Analyzed: Completed LNG-IUD Insertions
20 44
Measure Type: Number
Unit of Measure: Completed LNG-IUD Insertions
20 44
3.Secondary Outcome
Title To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion
Hide Description Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I: Immediate LNG-IUD Insertion Group Arm 2: Delayed LNG-IUD Insertion Group
Hide Arm/Group Description:
Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
Overall Number of Participants Analyzed 44 20
Measure Type: Number
Unit of Measure: percentage of participants
6.8 5.0
Time Frame Adverse data related to expulsion collected from the time of the IUD insertion and up to 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm 2
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/44 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/44 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heather Hohmann, MD
Organization: University o Pittsburgh
Phone: 412-641-1441
EMail: hhohmann@mail.magee.edu
Layout table for additonal information
Responsible Party: Heather Hohmann, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00475228     History of Changes
Other Study ID Numbers: Pitt IRB PRO06040004
First Submitted: May 16, 2007
First Posted: May 21, 2007
Results First Submitted: May 19, 2016
Results First Posted: May 9, 2017
Last Update Posted: May 9, 2017