Trial · NCT00475228
'Levonorgestrel IUD Insertion After D&E Procedure
NCT00475228, Phase 4, Completed, University of Pittsburgh; results first posted 2017-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 'Levonorgestrel IUD Insertion After D&E Procedure. Trials, record NCT00475228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00475228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 'Levonorgestrel IUD Insertion After D&E Procedure
- NCT number
- NCT00475228
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 93 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Contraceptive Usage
- Interventions
- Levonorgestrel IUD
- First posted
- 2007-05-21
- Last updated
- 2017-05-09
- Results first posted
- 2017-05-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | 6 months | 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). | percentage of participants | NUMBER |
| SECONDARY | To Examine the Number of Women Receiving the LNG-IUD in Each Group | 2 Months | 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. | Completed LNG-IUD Insertions | NUMBER |
| SECONDARY | To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion | 6 months | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | Arm I: Immediate LNG-IUD Insertion Group | 85.2 | 95% Confidence Interval 66.3 to 95.8 | percentage of participants | |
| The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment. | Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | 62.9 | 95% Confidence Interval 42.4 to 80.6 | percentage of participants | |
| To Examine the Number of Women Receiving the LNG-IUD in Each Group | Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | 20 | Completed LNG-IUD Insertions | ||
| To Examine the Number of Women Receiving the LNG-IUD in Each Group | Arm I: Immediate LNG-IUD Insertion Group | 44 | Completed LNG-IUD Insertions | ||
| To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion | Arm I: Immediate LNG-IUD Insertion Group | 6.8 | percentage of participants | ||
| To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion | Arm 2: Delayed LNG-IUD Insertion Group | 5.0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Immediate LNG-IUD Insertion Group | 44 | |
| Overall Study | STARTED | Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | 44 | |
| Overall Study | COMPLETED | Arm I: Immediate LNG-IUD Insertion Group | 27 | |
| Overall Study | COMPLETED | Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | 27 | |
| Overall Study | NOT COMPLETED | Arm I: Immediate LNG-IUD Insertion Group | 17 | |
| Overall Study | NOT COMPLETED | Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group | 17 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, all-cause mortality | Arm 2 | ||
| Total, other adverse events | Arm I | 0 | 44 |
| Total, other adverse events | Arm 2 | 0 | 44 |
| Total, serious adverse events | Arm I | 0 | 44 |
| Total, serious adverse events | Arm 2 | 0 | 44 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I vs Arm 2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00475228
GET https://conductscience.org/api/trials/v1/NCT00475228/registered