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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

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

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=99 Participants
21 years
STANDARD_DEVIATION 2.35 • n=107 Participants
21 years
STANDARD_DEVIATION 2.4 • n=206 Participants
Sex: Female, Male
Female
48 Participants
n=99 Participants
48 Participants
n=107 Participants
96 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
n=99 Participants
19 Participants
n=107 Participants
38 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants
n=99 Participants
29 Participants
n=107 Participants
58 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
12 Participants
n=99 Participants
14 Participants
n=107 Participants
26 Participants
n=206 Participants
Race (NIH/OMB)
White
34 Participants
n=99 Participants
33 Participants
n=107 Participants
67 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Region of Enrollment
United States
48 participants
n=99 Participants
48 participants
n=107 Participants
96 participants
n=206 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

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

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

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

Results disclosure agreements

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