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

A Randomized Controlled Trial: Contraceptive Counseling After an Abortion

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Behavioral: Treatment group: receives counseling phone call intervention

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Jody Steinauer, MD, MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: contraception
• Other Study ID Numbers: RCT 10-01978