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

Contraception Clinical Trial

— PPR  

Official title:

A Randomized Controlled Trial: Contraceptive Counseling After an Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199952
• Other study ID #: RCT 10-01978
• Status: Completed
• Phase: N/A
• Start date: March 21, 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks after abortion procedure
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	6 weeks after abortion procedure