Trial Outcomes & Findings for Initiating Contraception After Emergency Contraception From Pharmacy (NCT NCT01738971)

Results Overview

Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

6-8 weeks after EC

Results posted on

2014-08-18

Participant Flow

Recruitment from end April 2012 - end December 2012 (8 month period). Recruitment of participants by community pharmacists within 11 community pharmacies in Edinburgh. All participating pharmacists trained by the research team prior to commencing recruitment of participants.

Participant milestones

Participant milestones
Measure	Control (Standard Care) standard verbal and written advice on contraception from pharmacy	Rapid Access rapid access to family planning service rapid access to contraceptive service	Progestogen Only Pill one month progestogen only pill one month progestogen only pill
Overall Study STARTED	54	58	56
Overall Study COMPLETED	35	28	39
Overall Study NOT COMPLETED	19	30	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Control (Standard Care) standard verbal and written advice on contraception from pharmacy	Rapid Access rapid access to family planning service rapid access to contraceptive service	Progestogen Only Pill one month progestogen only pill one month progestogen only pill
Overall Study Lost to Follow-up	19	30	17

Baseline Characteristics

Initiating Contraception After Emergency Contraception From Pharmacy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control (Standard Care) n=35 Participants standard verbal and written advice on contraception from pharmacy	Rapid Access n=28 Participants rapid access to family planning service rapid access to contraceptive service	Progestogen Only Pill n=39 Participants one month progestogen only pill one month progestogen only pill	Total n=102 Participants Total of all reporting groups
Age, Continuous	23 years STANDARD_DEVIATION 4.5 • n=93 Participants	25 years STANDARD_DEVIATION 5.6 • n=4 Participants	22 years STANDARD_DEVIATION 5.2 • n=27 Participants	23 years STANDARD_DEVIATION 5.2 • n=483 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	28 Participants n=4 Participants	39 Participants n=27 Participants	102 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United Kingdom	35 participants n=93 Participants	28 participants n=4 Participants	39 participants n=27 Participants	102 participants n=483 Participants
Contraception use at time of enrollment None	12 participants n=93 Participants	8 participants n=4 Participants	13 participants n=27 Participants	33 participants n=483 Participants
Contraception use at time of enrollment Condoms	19 participants n=93 Participants	17 participants n=4 Participants	26 participants n=27 Participants	62 participants n=483 Participants
Contraception use at time of enrollment Other method	4 participants n=93 Participants	3 participants n=4 Participants	0 participants n=27 Participants	7 participants n=483 Participants

PRIMARY outcome

Timeframe: 6-8 weeks after EC

Population: A small number of participants were identified who had been recruited to the study although were already using an effective method of contraception (i.e. using a contraceptive pill but had forgot to take), and continued to use the same method at follow-up. These participants were excluded from analysis.

Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.

Outcome measures

Outcome measures
Measure	Control (Standard Care) n=31 Participants standard verbal and written advice on contraception from pharmacy	Rapid Access n=25 Participants rapid access to family planning service rapid access to contraceptive service	Progestogen Only Pill n=39 Participants one month progestogen only pill one month progestogen only pill
Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) Effective contraception	5 participants	13 participants	22 participants
Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) Long acting contraception	0 participants	5 participants	3 participants
Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) No contraception / barrier method	26 participants	12 participants	17 participants

SECONDARY outcome

Timeframe: 8 months

Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group.

Outcome measures

Outcome measures
Measure	Control (Standard Care) n=60 Participants standard verbal and written advice on contraception from pharmacy	Rapid Access n=60 Participants rapid access to family planning service rapid access to contraceptive service	Progestogen Only Pill n=60 Participants one month progestogen only pill one month progestogen only pill
Pharmacy Recruitment Rates Recruited	54 participants	58 participants	56 participants
Pharmacy Recruitment Rates Not recruited from target figure	6 participants	2 participants	4 participants

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Control (Standard Care) n=54 Participants standard verbal and written advice on contraception from pharmacy	Rapid Access n=58 Participants rapid access to family planning service rapid access to contraceptive service	Progestogen Only Pill n=56 Participants one month progestogen only pill one month progestogen only pill
Proportion of Women Who Agree to Participate Who Can be Successfully Contacted Women successfully contacted for follow-up	35 participants	28 participants	39 participants
Proportion of Women Who Agree to Participate Who Can be Successfully Contacted Not contacted / lost to follow-up	19 participants	30 participants	17 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

Adverse Events

Control (Standard Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapid Access

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Progestogen Only Pill

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

Dr Lucy Michie

University of Edinburgh

Phone: 0131 5361542

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place