An interventional study of Copper T 380A IUD in Contraception Behavior, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-09.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research
The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.
Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
Device: Copper T 380A IUD
The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
Device: Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Use of IUD
Number of participants using Copper T380A IUD 6 months after surgery
Time frame: 6 months
Expulsion
IUD was not removed by provider but fell out on its own.
Time frame: 6 months
| Milestone | A/Immediate | B/Delayed |
|---|---|---|
| Started | 104 | 111 |
| Completed | 71 | 88 |
| Not completed | 33 | 23 |
| Withdrew: Lost to follow-up | 33 | 23 |
Number of participants using Copper T380A IUD 6 months after surgery
| participants | A/Immediate | B/Delayed |
|---|---|---|
| Use of IUD | 58 | 25 |
IUD was not removed by provider but fell out on its own.
| percentage of expulsions | A/Immediate | B/Delayed |
|---|---|---|
| Expulsion | 3.1 | 0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A/Immediate | — | 0/104 (0%) | 2/104 (1.9%) |
| B/Delayed | — | 0/111 (0%) | 0/111 (0%) |
| Event | A/Immediate | B/Delayed |
|---|---|---|
| ExpulsionReproductive system and breast disorders | 2/104 | 0/111 |
215 subjects were enrolled and randomized to the A/Immediate or B/Delayed group.
| Age, Continuous(years) | A/Immediate | B/Delayed | Total |
|---|---|---|---|
| Mean | 24 (16 to 41) | 23.4 (16 to 43) | 23.7 (16 to 43) |
| Sex/Gender, Customized(participants) | A/Immediate | B/Delayed | Total |
|---|---|---|---|
| Female | 104 | 111 | 215 |
| Race/Ethnicity, Customized(participants) | A/Immediate | B/Delayed | Total |
|---|---|---|---|
| Black | 48 | 52 | 100 |
| Hispanic or Latino | 43 | 39 | 82 |
| White | 4 | 6 | 10 |
| Asian or South Asian | 1 | 4 | 5 |
| Mixed | 4 | 5 | 9 |
| Other | 2 | 3 | 5 |
| Missing | 2 | 2 | 4 |
| Gestational age(weeks) | A/Immediate | B/Delayed | Total |
|---|---|---|---|
| Mean | 19.2 (12 to 24) | 18.8 (12 to 24) | 19.0 (12 to 24) |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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