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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| contraception-Immediate start | Active Comparator | contraception after abortion and before leaving the clinic, observed by clinic staff |
|
| Contraception-Delayed start | Active Comparator | instructed to begin contraception the first Sunday after leaving the clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| timing of initiation of transdermal patch after an abortion | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Use Patch After Abortion, by Study Arm | we will also describe what participants were using two months post-abortion | six months after enrollment/abortion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | six months post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jody E Steinauer, MD, MAS | University of California, San Francisco | Principal Investigator |
| Sarah W Prager, MD | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Options Clinic at San Francisco General Hospital | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24176251 | Derived | Steinauer JE, Sokoloff A, Roberts EM, Drey EA, Dehlendorf CE, Prager SW. Immediate versus delayed initiation of the contraceptive patch after abortion: a randomized trial. Contraception. 2014 Jan;89(1):42-7. doi: 10.1016/j.contraception.2013.03.002. Epub 2013 Mar 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 Month Follow-up Survey |
| |||||||||||||
| 6 Month Follow-up Survey |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Use Patch After Abortion, by Study Arm | we will also describe what participants were using two months post-abortion | randomized subjects who completed the six month survey | Posted | Count of Participants | Participants | six months after enrollment/abortion |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Prager | University of Washington | 415-206-8715 | pragers@uw.edu |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| NOT COMPLETED |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | BMI |
|
| Prior patch use | Count of Participants | Participants |
|
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 |
|
|
| 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 | Posted | Count of Participants | Participants | six months post enrollment |
|
|
|
| 0 |
| 154 |
| 0 |
| 154 |
| EG001 | 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 | 0 | 144 | 0 | 144 |
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