Clinical trial NCT00475228
Conditions: Contraceptive Usage
Keywords: levonorgestrel IUD IUD dilation and evacuation contraception
Sponsor: University of Pittsburgh
Start date: 2007-03-01; Completion date: 2009-11-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

1. Group 1: IUD will be placed per study protocol. The strings will be trimmed to be flush with the cervix. Using transabdominal sonography, the distance from the serosal surface of the uterine fundus to the distal tip of the IUD will be measured.
2. Group 2: No additional procedures will be performed in the operating room.

Post-Operative Care. The subject will then be taken to the recovery room for routine post-operative care.

1. Group 1: A brief questionnaire will be administered. No additional procedures will be performed in the recovery room.
2. Group 2: A brief questionnaire will be administered. The subject will be asked to start her previously chosen method of contraception.
3. Subjects will be asked to call if any temperature exceeds 38°C (100.4°F). If a subject reports a fever (\>38°C), an interim visit will be scheduled as described below.

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.

Arms: arm 1: Levonorgestrel IUD will be inserted immediately after completion of D\&E arm 2: Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure)
Interventions: intervention 1: Levonorgestrel IUD
Intervention descriptions: intervention 1: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem

Protocol documents: