Abortion
Conditions
Keywords
abortion, randomized, contraception, pregnancy, compliance, continuation, contraceptive patch, transdermal hormonal contraception
Brief summary
This is a randomized, controlled trial investigating whether immediate versus standard, Sunday Start, initiation of transdermal hormonal contraception (the patch) in post-abortion subjects can improve compliance and the continuation of contraception. Immediate initiation of the patch has been studied in women seeking contraception when they are not immediately post-abortion, and this Quick Start method has been shown to improve the continuation of the patch into a second month. The primary hypothesis of this study is that immediate initiation of the patch in post-abortal women will improve the continuation of contraception over delayed initiation on the first Sunday after an abortion.
Detailed description
The United States has a higher rate of unintended pregnancy than Canada or any other developed nation in Europe. Hormonal contraception is the most common method of contraception used in this country. Perfect use can lead to failure rates as low as 0.1% per year. Actual failure rates are much higher, often due to non-compliance with contraception use. Several recent studies have examined the Quick Start, or initiation of hormonal contraception (OCPs and patch) in front of the provider while still at the clinic, regardless of time in the cycle. These studies have shown that women who placed the first patch in the clinic were more likely to continue the patch into the second month. Women who are seen in clinics for a therapeutic abortion (TAB) are often at extremely high risk for another unintended/unwanted pregnancy. If compliance in patch use could be improved in this group of women, unintended/unwanted pregnancy rates could be reduced. One concern about the Quick Start technique is that women may have already ovulated or conceived when the patch is initiated mid-cycle. In the post-abortal setting, this is not a concern. Applying the Quick Start technique to post-abortion patients and having women place the first patch while still in the clinic after their abortion may improve compliance and continuation of patch use. This is a prospective, randomized, controlled trial in post-abortal women, and will last approximately 24 months. All of the study subjects will receive a month's worth of the patch and a one-year prescription after their TAB. The women in the immediate start arm will then place their first patch in the clinic, observed by clinic staff, before leaving. The controls will be instructed to place the first patch on the first Sunday following their abortion. All subjects will receive the same medication with the only difference being the timing of initiation of the patch. Measurements of continuation will be determined by telephone interviews administered at two and six months after the subjects' abortion.
Interventions
BEHAVIORALtiming of initiation of transdermal patch after an abortion
the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Any woman aged 13-45 who presents to the Women's Options Clinic and desires to use the patch for post-abortion contraception.
Exclusion criteria
* Gestational age above 23 weeks and 1 day. * Any absolute contraindication for patch use (smoking \> 20 cigarettes a day over age 35, history of venous thromboembolic event or pulmonary embolism, history of or current ischemic heart disease, history of stroke, vascular disease, complicated valvular heart disease \[pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis\], severe hypertension with blood pressure \>160/100, migraines with focal neurologic symptoms, current breast cancer, active viral hepatitis, severe cirrhosis, or benign or malignant liver tumors). * Patients who speak languages other than English or Spanish. * Patients who do not have a phone or who have a phone where any contact might compromise the confidentiality of their abortions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Use Patch After Abortion, by Study Arm | six months after enrollment/abortion | we will also describe what participants were using two months post-abortion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment | six months post enrollment | An effective method is defined as a hormonal method or intra-uterine device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contraception-Immediate Start contraception after abortion and before leaving the clinic, observed by clinic staff
timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic | 154 |
| Contraception-Delayed Start instructed to begin contraception the first Sunday after leaving the clinic
timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic | 144 |
| Total | 298 |
Baseline characteristics
| Characteristic | Contraception-Delayed Start | Total | Contraception-Immediate Start |
|---|---|---|---|
| Age, Continuous | 22.5 years STANDARD_DEVIATION 5.2 | 22.2 years STANDARD_DEVIATION 5.3 | 21.9 years STANDARD_DEVIATION 5.3 |
| BMI | 24.9 BMI STANDARD_DEVIATION 4 | 24.9 BMI STANDARD_DEVIATION 4.3 | 25.0 BMI STANDARD_DEVIATION 4.5 |
| Insurance Medi-Cal/Emergency Medi-CAl | 118 Participants | 242 Participants | 124 Participants |
| Insurance Private or HMO | 5 Participants | 16 Participants | 11 Participants |
| Insurance Self-pay | 21 Participants | 40 Participants | 19 Participants |
| Prior patch use | 54 Participants | 107 Participants | 53 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African-American | 45 Participants | 91 Participants | 46 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian/PI | 24 Participants | 48 Participants | 24 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Latina | 47 Participants | 100 Participants | 53 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiracial/Other | 2 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 26 Participants | 51 Participants | 25 Participants |
| Sex: Female, Male Female | 144 Participants | 298 Participants | 154 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 / 154 | 0 / 144 |
| serious Total, serious adverse events | 0 / 154 | 0 / 144 |
Outcome results
Primary
Number of Participants Who Use Patch After Abortion, by Study Arm
we will also describe what participants were using two months post-abortion
Time frame: six months after enrollment/abortion
Population: randomized subjects who completed the six month survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Contraception-Immediate Start | Number of Participants Who Use Patch After Abortion, by Study Arm | 36 Participants |
| Contraception-Delayed Start | Number of Participants Who Use Patch After Abortion, by Study Arm | 42 Participants |
Secondary
Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment
An effective method is defined as a hormonal method or intra-uterine device
Time frame: six months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Contraception-Immediate Start | Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment | 46 Participants |
| Contraception-Delayed Start | Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment | 49 Participants |