A Phase 4 interventional study of CuT380A in Contraception, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-19.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
After medication abortion, women may quickly become pregnant again and therefore need an effective birth control method right away. Intrauterine devices (IUDs) are very effective for preventing pregnancy. IUDs are usually placed more than a month after abortion. This study will randomly assign women having a medication abortion to two groups, either having the IUD inserted one week after medication abortion or having the IUD inserted more than four weeks later. Women will be followed for six months to compare how many return for IUD placement in the two groups, how many are using the IUD after six months, experience with pain, bleeding, and cramping, how easy or difficult it is to insert the IUD, how many IUDs are expelled or removed, and how many women are using any birth control six months after the abortion.
Women presenting for medication abortion are highly motivated to initiate contraception and are also at high risk for repeat pregnancy. Intrauterine devices (IUDs) are among the most effective reversible methods. IUD insertion is routinely planned for at least four weeks after medication abortion. This leaves women vulnerable to pregnancy while waiting for IUD placement, and many will not return for this visit. While immediate IUD insertion after surgical abortion is known to be safe and effective, it has not been studied after medication abortion.
This study will recruit women undergoing medication abortion at Special Gynecology Services who desire an IUD for contraception. Women will be randomized to two groups: immediate insertion of the copper IUD at the routine one week follow up visit, or delayed insertion of the copper IUD at least four weeks after the medication abortion.
The primary objective of this study is to compare six month IUD prevalence between the immediate and delayed IUD insertion groups. Secondary outcomes include comparison of IUD insertion rates, continuation rates, expulsion and removal rates, and use of any contraception at six months. Pain experienced during insertion and provider ease of insertion will be recorded. A diary collected for four weeks following medication abortion will reveal the impact of early IUD placement on bleeding and cramping. Lastly, we will correlate endometrial stripe thickness and IUD position to outcomes of interest: continuation, expulsion, and removal rates.
Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Insertion of CuT380A at the routine medication abortion follow-up visit one week after initiation of a medication abortion
Device: CuT380A
Insertion of CuT380A four to six weeks after initiation of a medication abortion
Device: CuT380A
Comparison of different timing of IUD insertion
Also known as: IUD, Copper T
Use of the IUD for Contraception at Six Months
Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).
Time frame: 6 months
Insertion Rates
Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.
Time frame: By six months after medication abortion
Expulsion and Removal Rates
Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study. Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study.
Time frame: Within six months of medication abortion
Women presenting to Columbia University's Special Gynecology Services for medication abortion will receive comprehensive contraceptive counseling. Those interested in the Intrauterine Device (IUD) for contraception will be offered study participation. Those who accept enrollment in the study and sign consent will be randomized into 1 of 2 groups.
| Milestone | Immediate IUD Insertion | Delayed IUD Insertion |
|---|---|---|
| Started | 71 | 85 |
| Completed | 66 | 76 |
| Not completed | 5 | 9 |
Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.
| participants | Immediate IUD Insertion | Delayed IUD Insertion |
|---|---|---|
| Insertion Rates | 69 | 65 |
Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study. Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study.
| participants | Immediate IUD Insertion | Delayed IUD Insertion |
|---|---|---|
| Expulsions | 8 | 7 |
| Removals | 10 | 5 |
Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).
| participants | Immediate IUD Insertion | Delayed IUD Insertion |
|---|---|---|
| Use of the IUD for Contraception at Six Months | 49 | 51 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate IUD Insertion | — | 0/71 (0%) | 0/71 (0%) |
| Delayed IUD Insertion | — | 0/85 (0%) | 0/85 (0%) |
| Age, Categorical(Participants) | Immediate IUD Insertion | Delayed IUD Insertion | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 71 | 85 | 156 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Immediate IUD Insertion | Delayed IUD Insertion | Total |
|---|---|---|---|
| Female | 71 | 85 | 156 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Immediate IUD Insertion | Delayed IUD Insertion | Total |
|---|---|---|---|
| United States | 71 | 85 | 156 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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