Trial Outcomes & Findings for Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial (NCT NCT02866279)

NCT ID: NCT02866279

Last Updated: 2022-11-01

Results Overview

Exclusive Breastfeeding at 6 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 155 participants
• Primary outcome timeframe: 6 months postpartum
• Results posted on: 2022-11-01

Participant Flow

Participant milestones

Measure	Postplacental contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Immediate Postpartum Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Delayed Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement
Overall Study STARTED	51	52	52
Overall Study COMPLETED	51	52	52
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

Baseline characteristics by cohort

Measure	Postplacental n=51 Participants contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Immediate Postpartum n=52 Participants Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Delayed n=52 Participants Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Total n=155 Participants Total of all reporting groups
Age, Continuous	27 years STANDARD_DEVIATION 4.5 • n=93 Participants	27 years STANDARD_DEVIATION 4.6 • n=4 Participants	27 years STANDARD_DEVIATION 4.8 • n=27 Participants	27 years STANDARD_DEVIATION 4.6 • n=483 Participants
Sex: Female, Male Female	51 Participants n=93 Participants	52 Participants n=4 Participants	52 Participants n=27 Participants	155 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
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=93 Participants	32 Participants n=4 Participants	31 Participants n=27 Participants	95 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants	17 Participants n=4 Participants	18 Participants n=27 Participants	49 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	11 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	25 Participants n=93 Participants	18 Participants n=4 Participants	22 Participants n=27 Participants	65 Participants n=483 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	8 Participants n=4 Participants	6 Participants n=27 Participants	23 Participants n=483 Participants
Race (NIH/OMB) More than one race	17 Participants n=93 Participants	24 Participants n=4 Participants	24 Participants n=27 Participants	65 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants

PRIMARY outcome

Timeframe: 6 months postpartum

Exclusive Breastfeeding at 6 months

Outcome measures

Measure	Postplacental n=51 Participants contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Immediate Postpartum n=52 Participants Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Delayed n=52 Participants Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement
Number of Participants Breastfeeding at 6 Months	6 Participants	4 Participants	6 Participants

PRIMARY outcome

Timeframe: 1-5 days postpartum

Difference in time to Lactogenesis Stage II

Outcome measures

Measure	Postplacental n=51 Participants contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Immediate Postpartum n=52 Participants Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Delayed n=52 Participants Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement
Time to Lactogenesis Stage II	66.9 hours Standard Deviation 27.2	62.1 hours Standard Deviation 29.0	57.3 hours Standard Deviation 21.7

SECONDARY outcome

Timeframe: 0-6 months postpartum

Number of Participants that reported heavy bleeding at 6 months postpartum

Outcome measures

Measure	Postplacental n=51 Participants contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Immediate Postpartum n=52 Participants Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Delayed n=52 Participants Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement
Vaginal Bleeding	7 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: 0-6 months postpartum

Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum

Outcome measures

Measure	Postplacental n=51 Participants contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Immediate Postpartum n=52 Participants Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement	Delayed n=52 Participants Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement
Satisfaction With Contraceptive Implant	8.41 score on a scale Standard Deviation 2.01	8.14 score on a scale Standard Deviation 2.47	8.69 score on a scale Standard Deviation 1.60

Adverse Events

Postplacental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Immediate Postpartum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed

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

Erika Levi

Montefiore Medical Center

Phone: 7184058200

Email: elevi@montefiore.org

Results disclosure agreements

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