Contraception
Conditions
Keywords
IUD, Intrauterine device, Intrauterine contraception, Medication abortion, Medical abortion
Brief summary
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.
Detailed description
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.
Interventions
DEVICECuT380A
Comparison of different timing of IUD insertion
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing medication abortion * 18 or older * Desires IUD as birth control method for a minimum of six months * Speaks Spanish or English * Has a working phone number or pager * Is willing to attend visits and will be in the area for next six months * Has signed informed consent
Exclusion criteria
* Chlamydia, gonorrhea, or pelvic inflammatory disease within the past three months * Known bleeding diathesis including anti-coagulation * Uterine abnormality including sub-mucous myomas that significantly distort the uterine cavity * Current cervical, uterine, or ovarian malignancy * high-grade squamous intraepithelial lesion on most recent pap * IUD insertion contraindicated by the World Health Organization's Medical Eligibility Criteria for Contraceptive Use (category 3 or 4)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of the IUD for Contraception at Six Months | 6 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Rates | By six months after medication abortion | 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. |
| Expulsion and Removal Rates | Within six months of medication abortion | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
For both groups, the routine 1 week follow-up visit will confirm a successful medication abortion by passage of gestational sac on sonogram. Endometrial stripe thickness will be also be noted. For both groups a transvaginal sonogram will be performed immediately after IUD insertion to confirm IUD position.
Participants by arm
| Arm | Count |
|---|---|
| Immediate IUD Insertion IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion | 71 |
| Delayed IUD Insertion IUD insertion four to six weeks after initiation of a medication abortion | 85 |
| Total | 156 |
Baseline characteristics
| Characteristic | Immediate IUD Insertion | Delayed IUD Insertion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 85 Participants | 156 Participants |
| Region of Enrollment United States | 71 participants | 85 participants | 156 participants |
| Sex: Female, Male Female | 71 Participants | 85 Participants | 156 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 / 71 | 0 / 85 |
| serious Total, serious adverse events | 0 / 71 | 0 / 85 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate IUD Insertion | Use of the IUD for Contraception at Six Months | 49 participants |
| Delayed IUD Insertion | Use of the IUD for Contraception at Six Months | 51 participants |
p-value: 0.24Chi-squared
Secondary
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
Population: Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate IUD Insertion | Expulsion and Removal Rates | Expulsions | 8 participants |
| Immediate IUD Insertion | Expulsion and Removal Rates | Removals | 10 participants |
| Delayed IUD Insertion | Expulsion and Removal Rates | Expulsions | 7 participants |
| Delayed IUD Insertion | Expulsion and Removal Rates | Removals | 5 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate IUD Insertion | Insertion Rates | 69 participants |
| Delayed IUD Insertion | Insertion Rates | 65 participants |
p-value: <0.01Chi-squared