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This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation & evacuation (D&E) compared to delayed insertion 3-6 weeks post-D&E. Eighty-eight women undergoing D&E between 15 0/7 and 23 6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary outcome is LNG-IUD usage six months following enrollment. 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. Secondary outcomes include the proportion receiving an IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The utility of ultrasonography in predicting expulsion will also be examined. Anticipated problems include poor subject follow-up and coordinating the intra-operative study procedures.
The D&E will be performed in the usual fashion. The uterus will be sounded to the fundus. Once the D&E is complete, the investigator or co-investigator will check the post-enrollment exclusion criteria to ensure that no events during the D&E made the subject ineligible. If the subject remains eligible, the randomization packet will be opened.
Immediately Post-D&E Procedure.
Post-Operative Care. The subject will then be taken to the recovery room for routine post-operative care.
Day 21-42. Post-D&E Visit at 1 month (PAV 1): will be scheduled on a weekday between 8:30 am and 4:30 pm at the time most convenient for the subject. For Group 1, the visit may be on any day from day 21-42. For Group 2, the visit will be scheduled with the goal of inserting the LNG-IUD during the first 7 days of the menstrual cycle.
Subjects will complete a questionnaire about symptoms since the D&E, including pain and bleeding and subjects' history will be collected. Subjects also will complete a set of visual-analog scales about pain, bleeding, and quality of life. All subjects will have a bimanual exam to assess uterine size, cervical motion and adnexal tenderness. Women in Group 1 will have a speculum exam to measure and, if necessary, trim the IUD strings. The length of the segment trimmed will be measured and recorded. If cervicitis or vaginitis is suspected, further evaluation will be performed with diagnosis and treatment by CDC guidelines as indicated. Women in group 2 will have their IUD placed.
Day 56-70: Post-D&E Visit at 2 months (PAV 2): may be scheduled any time within days 56-70 but must be at least 21 days after PAV1. Subjects will complete a questionnaire and visual-analog scales about symptoms since the D&E, including pain, bleeding, and quality of life and subjects' history will be obtained. Bimanual Examination will be performed to assess uterine size, cervical motion and adnexal tenderness. A speculum exam will be done to measure the strings and trim, if necessary. The IUD-Fundal Distance will be assessed by endovaginal sonography.
Day 160-200: Telephone Interview at 6 month (TI 6). A questionnaire will be administered over the phone. Three attempts will be made to contact the subject by telephone. A certified letter with the questionnaire and a postage-paid envelope will be sent if the subject is not contacted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Levonorgestrel IUD will be inserted immediately after completion of D&E |
|
| Arm 2 | Active Comparator | Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUD | Drug | intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Examine the Number of Women Receiving the LNG-IUD in Each Group | 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). | 2 Months |
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Inclusion Criteria:
Exclusion Criteria:
Post-Enrollment Pre-Randomization Exclusion criteria (to be assessed at the completion of the D&E. These criteria will be used to define a group not eligible for immediate insertion. Since these complications contraindicate immediate insertion, the issue of whether immediate and delayed insertion is preferable is no longer in question.)
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| Name | Affiliation | Role |
|---|---|---|
| Heather Hohmann, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Center for Family Planning Research | Pittsburgh | Pennsylvania | 15215 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
After completion of the D&E, 88 of the 93 women who consented were randomized 1:1 to Arm 1 and Arm 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: Immediate LNG-IUD Insertion Group | Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E |
| BG001 | Arm 2: Delayed LNG-IUD Insertion Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
Adverse data related to expulsion collected from the time of the IUD insertion and up to 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Hohmann, MD | University o Pittsburgh | 412-641-1441 | hhohmann@mail.magee.edu |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion |
Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group |
| 6 months |
Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | 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
| OG001 | 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 |
|
|
|
| Secondary | To Examine the Number of Women Receiving the LNG-IUD in Each Group | 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). | 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. | Posted | Number | Completed LNG-IUD Insertions | 2 Months | Completed LNG-IUD Insertions | Completed LNG-IUD Insertions |
|
|
|
| Secondary | To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion | Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group | 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. | Posted | Number | percentage of participants | 6 months |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Arm 2 | 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 | 0 | 44 | 0 | 44 |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |