RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion?

NCT ID: NCT01199952

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-21
• Study Completion Date: 2013-01-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

The control group will not receive a counseling phone call one month after enrollment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Treatment group: receives counseling phone call intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jody Steinauer, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

RCT 10-01978

Identifier Type: -

Identifier Source: org_study_id