Trial Outcomes & Findings for Immediate vs. Delayed Postpartum Etonogestrel Implant (NCT NCT01767285)

Results Overview

To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

1 year

Results posted on

2017-02-28

Participant Flow

60 participants signed consent. 1 participant was a screen failure. 59 participants were randomized.

Participant milestones

Participant milestones
Measure	Immediate Postpartum Etonogestrel Implant Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Overall Study STARTED	29	30
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immediate vs. Delayed Postpartum Etonogestrel Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Postpartum Etonogestrel Implant n=29 Participants Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant n=30 Participants These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Female	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Participants who completed the 1 year phone visit were included in analysis.

To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.

Outcome measures

Outcome measures
Measure	Immediate Postpartum Etonogestrel Implant n=22 Participants Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant n=21 Participants These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Continuation Rate	20 participants	18 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants who completed the 6 week assessment.

To identify differences in the rates of intercourse prior to the 6-week postpartum visit.

Outcome measures

Outcome measures
Measure	Immediate Postpartum Etonogestrel Implant n=26 Participants Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant n=28 Participants These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Rate of Intercourse	8 participants	14 participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants who completed the 6 month assessment.

To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.

Outcome measures

Outcome measures
Measure	Immediate Postpartum Etonogestrel Implant n=27 Participants Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant n=28 Participants These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Continuation Rate	27 participants	21 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Participants who completed the 6 month assessment.

To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.

Outcome measures

Outcome measures
Measure	Immediate Postpartum Etonogestrel Implant n=27 Participants Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant n=28 Participants These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Continuation of Breastfeeding	6 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: all participants who completed the 12 month follow up visit

To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.

Outcome measures

Outcome measures
Measure	Immediate Postpartum Etonogestrel Implant n=22 Participants Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant n=24 Participants These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Pregnancy Rate	0 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Participants who completed the 12 month patient satisfaction assessment.

To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.

Outcome measures

Outcome measures
Measure	Immediate Postpartum Etonogestrel Implant n=22 Participants Etonogestrel implant placed in the hospital after delivery, before discharge home. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.	Delayed Postpartum Etonogestrel Implant n=21 Participants These subjects will have the etonogestrel implant placed at the 6 week postpartum visit. Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Patient Satisfaction	15 participants	13 participants

Adverse Events

Immediate Postpartum Etonogestrel Implant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Postpartum Etonogestrel 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

Dr. Beverly Gray

Duke University

Phone: 919-684-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place