Contraceptive Usage
Conditions
Keywords
levonorgestrel IUD, IUD, dilation and evacuation, contraception
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.
Interventions
intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Gestational age from 15 weeks 0 days to 23 weeks 6 days at enrollment (time of D&E), confirmed by ultrasound 2. Has already consented to a D&E 3. Desires to use the LNG-IUD (Mirena) for contraception for 12 months or more 4. Willing and able to sign an informed consent 5. Willing to comply with the study protocol 6. Age greater than or equal to 18 years 7. Primary residency in Allegheny, Beaver, Washington, Westmoreland, Butler, Armstrong, Indiana, Fayette, Greene, or Lawrence counties of Pennsylvania
Exclusion criteria
1. Allergy to either polyethylene or levonorgestrel 2. Urgent need for termination of pregnancy (active bleeding or infection) 3. Exposure to or treatment for gonorrhea or Chlamydia within the past 90 days 4. Diagnosis of pelvic inflammatory disease within the past year 5. Presence of one or more leiomyomata greater than 3 centimeters in diameter 6. Uterine anomaly (other than a repaired septate uterus) 7. Current participation in any other intervention trial Post-Enrollment Pre-Randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Examine the Number of Women Receiving the LNG-IUD in Each Group | 2 Months | 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). |
| To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion | 6 months | Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 44 |
| Arm 2: Delayed LNG-IUD Insertion Group Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice. | 44 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 17 |
Baseline characteristics
| Characteristic | Arm I: Immediate LNG-IUD Insertion Group | Arm 2: Delayed LNG-IUD Insertion Group | Total |
|---|---|---|---|
| Age, Customized at least 18 years of age | 44 participants | 44 participants | 88 participants |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: Immediate LNG-IUD Insertion Group | The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | 85.2 percentage of participants |
| Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | 62.9 percentage of participants |
p-value: 0.05Chi-squared
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
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: Immediate LNG-IUD Insertion Group | To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion | 6.8 percentage of participants |
| Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion | 5.0 percentage of participants |
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: Immediate LNG-IUD Insertion Group | To Examine the Number of Women Receiving the LNG-IUD in Each Group | 20 Completed LNG-IUD Insertions |
| Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | To Examine the Number of Women Receiving the LNG-IUD in Each Group | 44 Completed LNG-IUD Insertions |