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

NCT01199952 | Completed Results

• 1 other identifier: RCT 10-01978
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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

Keywords

contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reasons for Discontinuation of Contraception

  6 weeks after abortion procedure

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Interventions

Treatment group: receives counseling phone call intervention 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.

Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who do not speak and read English or Spanish

Sponsors & Collaborators

• University of California, San Francisco: lead
• Society of Family Planning: collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Results Point of Contact

• Title: Director for Research Operations
• Organization: University of California, San Francisco

abby.sokoloff@ucsf.edu

415-206-2476

Study Officials

• Jody Steinauer, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: March 21, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 19, 2019
• Results First Posted: September 19, 2019

Record last verified: 2019-08

Locations

US (1)