Contraception
Conditions
Keywords
contraception
Brief summary
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 * 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 This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.
Interventions
BEHAVIORALTreatment 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.
Sponsors
Society of Family Planning
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women over the age of 15 who choose pill, patch or ring to begin after their abortion * Women able and willing to be contacted by phone for up to 2 months after enrollment
Exclusion criteria
* Women who do not speak and read English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion | 6 weeks after abortion procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Reasons for Discontinuation of Contraception | 6 weeks after abortion procedure | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control The control group will not receive a counseling phone call one month after enrollment. | 103 |
| 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. | 104 |
| Total | 207 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 24.4 years STANDARD_DEVIATION 6.2 | 24.8 years STANDARD_DEVIATION 6.1 | 25.1 years STANDARD_DEVIATION 4.9 |
| Race/Ethnicity, Customized Race African-American | 37 Participants | 66 Participants | 29 Participants |
| Race/Ethnicity, Customized Race Asian | 19 Participants | 30 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Hispanic | 22 Participants | 58 Participants | 36 Participants |
| Race/Ethnicity, Customized Race Native American/Eskimo | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/Pacific Islander | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Unknown | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 18 Participants | 36 Participants | 18 Participants |
| Sex/Gender, Customized only female in study | 104 Participants | 207 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 104 |
| other Total, other adverse events | 0 / 103 | 0 / 104 |
| serious Total, serious adverse events | 0 / 103 | 0 / 104 |
Outcome results
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.
Time frame: 6 weeks after abortion procedure
Population: study sample is female only since study is birth control selected following surgical abortion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion | 55 Participants |
| Intervention | Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion | 55 Participants |
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
Time frame: 6 weeks after abortion procedure
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Reasons for Discontinuation of Contraception | worried wouldn't be able to get pregnant | 7 Participants |
| Control | Reasons for Discontinuation of Contraception | My doctor told me to stop | 1 Participants |
| Control | Reasons for Discontinuation of Contraception | Couldn't get more | 7 Participants |
| Control | Reasons for Discontinuation of Contraception | My friends thought that I should stop | 2 Participants |
| Control | Reasons for Discontinuation of Contraception | Couldn't afford it | 3 Participants |
| Control | Reasons for Discontinuation of Contraception | Other reason | 18 Participants |
| Control | Reasons for Discontinuation of Contraception | My partner wanted me to stop using it | 2 Participants |
| Control | Reasons for Discontinuation of Contraception | No other reason | 23 Participants |
| Control | Reasons for Discontinuation of Contraception | Stopped having sex | 14 Participants |
| Intervention | Reasons for Discontinuation of Contraception | No other reason | 23 Participants |
| Intervention | Reasons for Discontinuation of Contraception | Stopped having sex | 11 Participants |
| Intervention | Reasons for Discontinuation of Contraception | worried wouldn't be able to get pregnant | 6 Participants |
| Intervention | Reasons for Discontinuation of Contraception | Couldn't afford it | 5 Participants |
| Intervention | Reasons for Discontinuation of Contraception | Couldn't get more | 8 Participants |
| Intervention | Reasons for Discontinuation of Contraception | My partner wanted me to stop using it | 2 Participants |
| Intervention | Reasons for Discontinuation of Contraception | My doctor told me to stop | 1 Participants |
| Intervention | Reasons for Discontinuation of Contraception | My friends thought that I should stop | 1 Participants |
| Intervention | Reasons for Discontinuation of Contraception | Other reason | 15 Participants |