RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion? (CAHRP)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01199952
First received: September 9, 2010
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Contraception |
Behavioral: Treatment group: receives counseling phone call intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Trial: Contraceptive Counseling After an Abortion |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- use of an effective contraceptive method 6 weeks after abortion [ Time Frame: 6 weeks after abortion procedure ] [ Designated as safety issue: No ]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 Outcome Measures:
- reasons for discontinuation or continuation of contraception [ Time Frame: 6 weeks after abortion procedure ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 196 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
The control group will not receive a counseling phone call one month after enrollment.
|
|
|
Experimental: 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.
|
Behavioral: 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.
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199952
Locations
| United States, California | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
Sponsors and Collaborators
University of California, San Francisco
Society of Family Planning
Investigators
| Principal Investigator: | Jody Steinauer, MD, MAS | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01199952 History of Changes |
| Other Study ID Numbers: | RCT 10-01978 |
| Study First Received: | September 9, 2010 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
contraception |
ClinicalTrials.gov processed this record on May 23, 2013