Trial Outcomes & Findings for Postpartum Etonogestrel Implant for Adolescents (NCT NCT01666912)

NCT ID: NCT01666912

Last Updated: 2017-05-01

Results Overview

The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 96 participants
• Primary outcome timeframe: 12-14 months
• Results posted on: 2017-05-01

Participant Flow

Participant milestones

Measure	6 Week Postpartum Contraceptive Implant randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant	Immediate Postpartum Contraceptive Implant randomized to receive contraceptive implant prior to leaving the hospital postpartum Contraceptive implant
Overall Study STARTED	48	48
Overall Study COMPLETED	27	37
Overall Study NOT COMPLETED	21	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postpartum Etonogestrel Implant for Adolescents

Baseline characteristics by cohort

Measure	6 Week Postpartum Contraceptive Implant n=48 Participants randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant	Immediate Postpartum Contraceptive Implant n=48 Participants randomized to receive contraceptive implant prior to leaving the hospital postpartum Contraceptive implant	Total n=96 Participants Total of all reporting groups
Age, Continuous	21 years STANDARD_DEVIATION 2.58 • n=5 Participants	21 years STANDARD_DEVIATION 2.35 • n=7 Participants	21 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	48 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-14 months

The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.

Outcome measures

Measure	6 Week Postpartum Contraceptive Implant n=27 Participants randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant	Immediate Postpartum Contraceptive Implant n=37 Participants randomized to receive contraceptive implant prior to leaving the hospital postpartum Contraceptive implant
Continuation at 1 Year	21 participants	30 participants

SECONDARY outcome

Timeframe: 12 months

To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied."

Outcome measures

Measure	6 Week Postpartum Contraceptive Implant n=27 Participants randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant	Immediate Postpartum Contraceptive Implant n=37 Participants randomized to receive contraceptive implant prior to leaving the hospital postpartum Contraceptive implant
Satisfaction	8.68 units on a scale Standard Deviation 1.36	8.29 units on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: 12 months

To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.

Outcome measures

Measure	6 Week Postpartum Contraceptive Implant n=27 Participants randomized to receive contraceptive implant at normal 6 week postpartum visit Contraceptive implant	Immediate Postpartum Contraceptive Implant n=37 Participants randomized to receive contraceptive implant prior to leaving the hospital postpartum Contraceptive implant
Rapid Repeat Pregnancy	2 participants Interval 1.0 to 5.0	5 participants Interval 4.0 to 6.0

Adverse Events

6 Week Postpartum Contraceptive Implant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Immediate Postpartum Contraceptive Implant

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

Amy G. Bryant, Assistant Professor

UNC_ChapelHill

Phone: 919-843-5633

Email: amy_bryant@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place