Trial Outcomes & Findings for RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion? (NCT NCT01199952)

NCT ID: NCT01199952

Last Updated: 2019-09-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

207 participants

Primary outcome timeframe

6 weeks after abortion procedure

Results posted on

2019-09-19

Participant Flow

subjects were recruited at the county hospital abortion clinic from 3/21/2011 to 5/25/2012. Follow up phone calls were conducted 6 week and 6 months after enrollment, with the final follow-up completed 1/2/2013.

Participant milestones

Participant milestones
Measure	Control The control group will not receive a counseling phone call one month after enrollment.	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.
Overall Study STARTED	103	104
Overall Study COMPLETED	51	59
Overall Study NOT COMPLETED	52	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=103 Participants The control group will not receive a counseling phone call one month after enrollment.	Intervention n=104 Participants 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.	Total n=207 Participants Total of all reporting groups
Age, Continuous	25.1 years STANDARD_DEVIATION 4.9 • n=5 Participants	24.4 years STANDARD_DEVIATION 6.2 • n=7 Participants	24.8 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex/Gender, Customized only female in study	103 Participants n=5 Participants	104 Participants n=7 Participants	207 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Race · African-American	29 Participants n=5 Participants	37 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	36 Participants n=5 Participants	22 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native American/Eskimo	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian/Pacific Islander	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks after abortion procedure

Population: study sample is female only since study is birth control selected following surgical abortion

Outcome measures

Outcome measures
Measure	Control n=103 Participants The control group will not receive a counseling phone call one month after enrollment.	Intervention n=104 Participants 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. 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.
Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion	55 Participants	55 Participants

SECONDARY outcome

Timeframe: 6 weeks after abortion procedure

Population: number who responded to 6 week follow-up contact responses to outcome measures were not mutually exclusive, and therefore will not add up to the total number of participants who responded to the six week survey/contact.

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

Outcome measures

Outcome measures
Measure	Control n=69 Participants The control group will not receive a counseling phone call one month after enrollment.	Intervention n=75 Participants 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. 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.
Reasons for Discontinuation of Contraception No other reason	23 Participants	23 Participants
Reasons for Discontinuation of Contraception Stopped having sex	14 Participants	11 Participants
Reasons for Discontinuation of Contraception worried wouldn't be able to get pregnant	7 Participants	6 Participants
Reasons for Discontinuation of Contraception Couldn't afford it	3 Participants	5 Participants
Reasons for Discontinuation of Contraception Couldn't get more	7 Participants	8 Participants
Reasons for Discontinuation of Contraception My partner wanted me to stop using it	2 Participants	2 Participants
Reasons for Discontinuation of Contraception My doctor told me to stop	1 Participants	1 Participants
Reasons for Discontinuation of Contraception My friends thought that I should stop	2 Participants	1 Participants
Reasons for Discontinuation of Contraception Other reason	18 Participants	15 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director for Research Operations

University of California, San Francisco

Phone: 415-206-2476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place