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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00475228 |
This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation
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.
Condition | Intervention | Phase |
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Contraception |
Drug: Levonorgestrel IUD |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Immediate Versus Delayed Insertion of the Levonorgestrel-Releasing Intrauterine Device Following Dilation and Evacuation: A Randomized Controlled Trial |
Estimated Enrollment: | 97 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Insertion of IUD immediately after completion of D&E
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Drug: 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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2: Active Comparator
Insertion of IUD at standard time post-procedure (3-6 weeks post D&E procedure)
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Drug: 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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The D&E will be performed by the investigator or a co-investigator in the usual fashion. The uterus will be sounded to the fundus. Once the D&E is complete, the surgeon 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-Abortion 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-Abortion 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.)
United States, Pennsylvania | |
University of Pittsburgh Center for Family Planning Research | |
Pittsburgh, Pennsylvania, United States, 15215 |
Principal Investigator: | Heather Hohmann, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Heather Hohmann, MD ) |
Study ID Numbers: | Pitt IRB PRO06040004 |
Study First Received: | May 16, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00475228 History of Changes |
Health Authority: | United States: Institutional Review Board |
levonorgestrel IUD IUD dilation and evacuation second trimester contraception |
Dilatation, Pathologic Contraceptive Agents Levonorgestrel Contraceptives, Oral Contraceptive Agents, Female |
Contraceptive Agents Therapeutic Uses Levonorgestrel Contraceptives, Oral Physiological Effects of Drugs |
Contraceptive Agents, Female Contraceptives, Oral, Synthetic Reproductive Control Agents Pharmacologic Actions |