Contraceptive UsagePhase 4ILIADNCT00475228
'Levonorgestrel IUD Insertion After D&E Procedure
A Phase 4 study testing Levonorgestrel IUD in people with Contraceptive Usage, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Levonorgestrel IUD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age from 15 weeks 0 days to 23 weeks 6 days at enrollment (time of D\&E), confirmed by ultrasound
- Has already consented to a D\&E
- Desires to use the LNG-IUD (Mirena) for contraception for 12 months or more
- Willing and able to sign an informed consent
- Willing to comply with the study protocol
- Age greater than or equal to 18 years
- Primary residency in Allegheny, Beaver, Washington, Westmoreland, Butler, Armstrong, Indiana, Fayette, Greene, or Lawrence counties of Pennsylvania
Who cannot join
- Allergy to either polyethylene or levonorgestrel
- Urgent need for termination of pregnancy (active bleeding or infection)
- Exposure to or treatment for gonorrhea or Chlamydia within the past 90 days
- Diagnosis of pelvic inflammatory disease within the past year
- Presence of one or more leiomyomata greater than 3 centimeters in diameter
- Uterine anomaly (other than a repaired septate uterus)
Show all 12Show fewer
- Current participation in any other intervention trial
- 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.)
- Uterine perforation
- Hemorrhage as defined by one of the following: (1) need for transfusion; (2) estimated blood loss greater than 500 cc; (3) intrauterine placement of a Foley catheter; or (4) the use of 3 or more doses of uterotonic medications
- Evidence of infection at the time of the D\&E, including fever (temperature ≥ 38°C) or pus at the cervical os
- Subject no longer desires a LNG-IUD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Center for Family Planning Research
Pittsburgh, Pennsylvania, 15215
About this study
Official title: Immediate Versus Delayed Insertion of the Levonorgestrel-Releasing Intrauterine Device Following Dilation and Evacuation: A Randomized Controlled Trial
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.
Read the 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.
- 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.
- 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.
- Group 1: A brief questionnaire will be administered. No additional procedures will be performed in the recovery room.
- Group 2: A brief questionnaire will be administered. The subject will be asked to start her previously chosen method of contraception.
- 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.
- Conditions
- Contraceptive Usage
- Being tested
- Levonorgestrel IUD
- Keywords
- levonorgestrel IUD, IUD, dilation and evacuation, contraception
- Medical subject headings
- Contraception Behavior, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUDDrug
Also called Mirena
intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Levonorgestrel IUD will be inserted immediately after completion of D\&E Receives: Drug: Levonorgestrel IUD |
| Arm 2 | Active comparator | Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) Receives: Drug: Levonorgestrel IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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).
Measured: 2 Months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Hohmann, University of Pittsburgh
- Investigators
- Heather Hohmann, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475228
- Sponsor's protocol ID
- Pitt IRB PRO06040004
- Acronym
- ILIAD
- Status last verified
- Mar 2017
- First submitted
- 16 May 2007
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Insertion of the Levonorgestrel-Releasing Intrauterine Device Following Dilation and Evacuation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00475228
- Acronym / sponsor ID
- ILIAD / Pitt IRB PRO06040004
- Conditions
- Contraceptive Usage
- Keywords
- levonorgestrel IUD, IUD, dilation and evacuation, contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 9 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- Group 1: A brief questionnaire will be administered. No additional procedures will be performed in the recovery room.
- Group 2: A brief questionnaire will be administered. The subject will be asked to start her previously chosen method of contraception.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Levonorgestrel IUDLevonorgestrel IUD will be inserted immediately after completion of D\&E |
| Arm 2 | Active comparator | Drug: Levonorgestrel IUDLevonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gestational age from 15 weeks 0 days to 23 weeks 6 days at enrollment (time of D\&E), confirmed by ultrasound
- Has already consented to a D\&E
- Desires to use the LNG-IUD (Mirena) for contraception for 12 months or more
- Willing and able to sign an informed consent
- Willing to comply with the study protocol
Key exclusion criteria (12 listed)
- Allergy to either polyethylene or levonorgestrel
- Urgent need for termination of pregnancy (active bleeding or infection)
- Exposure to or treatment for gonorrhea or Chlamydia within the past 90 days
- Diagnosis of pelvic inflammatory disease within the past year
- Presence of one or more leiomyomata greater than 3 centimeters in diameter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel IUDAlso: Mirenaintrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem | Drug | Arm 2, Arm I |
Primary outcome
The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.
Time frame: 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.
2 secondary outcomes
To Examine the Number of Women Receiving the LNG-IUD in Each Group
Time frame: 2 Months
To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Hohmann, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levonorgestrel IUD in people with Contraceptive Usage, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.