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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group.
Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
Secondary Aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will not receive a counseling phone call one month after enrollment. | |
| Intervention | Experimental | Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment group: receives counseling phone call intervention | Behavioral | Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion | To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention. | 6 weeks after abortion procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Discontinuation of Contraception | To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion. To describe the concerns that lead to discontinuation or method change. To assess feasibility of conducting a follow-up telephone call in this population | 6 weeks after abortion procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jody Steinauer, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States |
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subjects were recruited at the county hospital abortion clinic from 3/21/2011 to 5/25/2012.
Follow up phone calls were conducted 6 week and 6 months after enrollment, with the final follow-up completed 1/2/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control group will not receive a counseling phone call one month after enrollment. |
| FG001 | Intervention | Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of baseline participants matches the Participant Flow, n=207
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control group will not receive a counseling phone call one month after enrollment. |
| BG001 | Intervention | Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception. |
| 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 Using an Effective Contraceptive Method 6 Weeks After Abortion | To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention. | study sample is female only since study is birth control selected following surgical abortion | Posted | Count of Participants | Participants | 6 weeks after abortion procedure |
|
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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 | Control | The control group will not receive a counseling phone call one month after enrollment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director for Research Operations | University of California, San Francisco | 415-206-2476 | abby.sokoloff@ucsf.edu |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception.
Treatment group: receives counseling phone call intervention: Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment.
|
|
| Secondary | Reasons for Discontinuation of Contraception | To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion. To describe the concerns that lead to discontinuation or method change. To assess feasibility of conducting a follow-up telephone call in this population | number who responded to 6 week follow-up contact responses to outcome measures were not mutually exclusive, and therefore will not add up to the total number of participants who responded to the six week survey/contact. | Posted | Count of Participants | Participants | No | 6 weeks after abortion procedure |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Intervention | Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception. | 0 | 104 | 0 | 104 | 0 | 104 |
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| Couldn't afford it |
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| Couldn't get more |
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| My partner wanted me to stop using it |
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| My doctor told me to stop |
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| My friends thought that I should stop |
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| Other reason |
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| No other reason |
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