Trial Outcomes & Findings for Breastfeeding Etonogestrel Implant Study (NCT NCT03978598)
NCT ID: NCT03978598
Last Updated: 2025-11-28
Results Overview
Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
For the primary outcome will be the first eight weeks after delivery.
Results posted on
2025-11-28
Participant Flow
Participant milestones
| Measure |
Immediate Insertion Group
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
Etonogestrel: Immediate v. Standard insertion.
Nexplanon: Implant.
|
Standard Postpartum Insertion Group
Insertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.
Etonogestrel: Immediate v. Standard insertion.
Nexplanon: Implant.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
72
|
|
Overall Study
Modified Intention to Treat
|
69
|
57
|
|
Overall Study
COMPLETED
|
62
|
53
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breastfeeding Etonogestrel Implant Study
Baseline characteristics by cohort
| Measure |
Immediate Insertion Group, Per Protocol
n=62 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention.
|
Standard Postpartum Insertion Group, Per Protocol
n=53 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 5.5 • n=30 Participants
|
27.2 years
STANDARD_DEVIATION 5.3 • n=30 Participants
|
27.7 years
STANDARD_DEVIATION 5.4 • n=60 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=30 Participants
|
53 Participants
n=30 Participants
|
115 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
44 participants
n=30 Participants
|
44 participants
n=30 Participants
|
88 participants
n=60 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=30 Participants
|
7 participants
n=30 Participants
|
11 participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=30 Participants
|
1 participants
n=30 Participants
|
3 participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
34 participants
n=30 Participants
|
26 participants
n=30 Participants
|
60 participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 participants
n=30 Participants
|
15 participants
n=30 Participants
|
30 participants
n=60 Participants
|
|
Parity
|
2 Parity
n=30 Participants
|
1 Parity
n=30 Participants
|
2 Parity
n=60 Participants
|
|
Previously used implant
|
26 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
42 Participants
n=60 Participants
|
|
Previously breastfed
|
33 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
56 Participants
n=60 Participants
|
|
Planning to breastfeed more than 6 months
|
51 Participants
n=30 Participants
|
47 Participants
n=30 Participants
|
98 Participants
n=60 Participants
|
|
Delivery mode
Vaginal
|
51 Participants
n=30 Participants
|
39 Participants
n=30 Participants
|
90 Participants
n=60 Participants
|
|
Delivery mode
Cesarean
|
9 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
22 Participants
n=60 Participants
|
|
Delivery mode
Operative vaginal
|
2 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Epidural
|
43 Participants
n=30 Participants
|
35 Participants
n=30 Participants
|
78 Participants
n=60 Participants
|
|
Recruitment site
University of New Mexico
|
50 Participants
n=30 Participants
|
45 Participants
n=30 Participants
|
95 Participants
n=60 Participants
|
|
Recruitment site
University of Utah
|
12 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: For the primary outcome will be the first eight weeks after delivery.Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=57 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=69 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
n=62 Participants
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
n=53 Participants
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum
|
45 Participants
|
54 Participants
|
48 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks postpartum.Using a questionnaire the investigators seek to compare exclusive breastfeeding through 6 months postpartum between the immediate versus the standard group. This will be assessed by answering a trichotomous question with the following statement: If you are currently breastfeeding, are you: * Exclusively breastfeeding * Breastfeeding and supplementing breastfeeding with bottles of breast milk * Breastfeeding and supplementing breastfeeding with bottles of formula
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=53 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=56 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Exclusive Breastfeeding
|
9 Participants
|
13 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks postpartum.Population: Some subjects provided partial data or no data at all.
Using a questionnaire the investigators seek to compare factors associated with discontinuing breastfeeding between the immediate versus the standard group. Subjects were asked to rate the importance of seven different factors independently, on a 4-item Likert scale from 0 = Not at all important, to 3 = Very important
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=26 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=28 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Factors Associated With Breastfeeding Discontinuation.
Baby had trouble sucking or latching
|
3 score on a Likert scale
Interval 0.0 to 3.0
|
0.5 score on a Likert scale
Interval 0.0 to 2.75
|
—
|
—
|
|
Factors Associated With Breastfeeding Discontinuation.
Baby got sick
|
0 score on a Likert scale
Interval 0.0 to 0.25
|
0 score on a Likert scale
Interval 0.0 to 0.0
|
—
|
—
|
|
Factors Associated With Breastfeeding Discontinuation.
I was sick
|
0 score on a Likert scale
Interval 0.0 to 2.0
|
0 score on a Likert scale
Interval 0.0 to 0.0
|
—
|
—
|
|
Factors Associated With Breastfeeding Discontinuation.
Provider said baby was underweight
|
0 score on a Likert scale
Interval 0.0 to 1.25
|
0 score on a Likert scale
Interval 0.0 to 0.0
|
—
|
—
|
|
Factors Associated With Breastfeeding Discontinuation.
Insufficient milk
|
2 score on a Likert scale
Interval 0.0 to 3.0
|
2 score on a Likert scale
Interval 0.0 to 3.0
|
—
|
—
|
|
Factors Associated With Breastfeeding Discontinuation.
I had trouble; breast issues
|
1.5 score on a Likert scale
Interval 0.0 to 3.0
|
0 score on a Likert scale
Interval 0.0 to 0.0
|
—
|
—
|
|
Factors Associated With Breastfeeding Discontinuation.
I quit breastfeeding; life issues
|
0 score on a Likert scale
Interval 0.0 to 2.0
|
2 score on a Likert scale
Interval 0.0 to 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At enrollment.Population: Some subjects provided partial data or no data at all.
Person-Centered Contraceptive Counseling Measure (PCCC Measure) pcccmeasure.ucsf.edu Scale range: 1. Poor 2. Fair 3. Good 4. Very Good 5. Excellent Higher values represent higher satisfaction and patient-centeredness
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=53 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=62 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Satisfaction With Postpartum Contraception Counseling
Respecting me as a person
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 5.0 to 5.0
|
—
|
—
|
|
Satisfaction With Postpartum Contraception Counseling
Letting me say what mattered to me about my birth control method
|
5 score on a scale
Interval 4.0 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
—
|
—
|
|
Satisfaction With Postpartum Contraception Counseling
Taking my preferences about my birth control seriously
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
—
|
—
|
|
Satisfaction With Postpartum Contraception Counseling
Giving me enough information to make the best decision about my birth control method
|
5 score on a scale
Interval 4.0 to 5.0
|
5 score on a scale
Interval 5.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At 2, 4, and 8 weeks postpartum.Population: Some subjects provided partial data or no data at all.
To compare postpartum mood as measured by Edinburgh Postnatal Depression Scale (EPDS) score at 2, 4, and 8 weeks postpartum. Results reported as a total score ranging from 0-30, no subscale scores. A higher scale represents a worse outcome, ie. is more predictive of a depressive disorder including postpartum depression.
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=53 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=62 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Postpartum Mood
2 weeks postpartum
|
1 EPDS Score
Interval 1.0 to 8.0
|
2 EPDS Score
Interval 1.0 to 5.0
|
—
|
—
|
|
Postpartum Mood
4 weeks postpartum
|
4 EPDS Score
Interval 1.0 to 7.0
|
2 EPDS Score
Interval 1.0 to 6.0
|
—
|
—
|
|
Postpartum Mood
8 weeks postpartum
|
4 EPDS Score
Interval 1.0 to 7.0
|
3 EPDS Score
Interval 1.0 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At 4, 8, and 12 weeks postpartumPopulation: Some subjects provided partial data or no data at all.
To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score. Minimum score 2, Maximum score 36. Subscales are combined by first totaling the scores for the individual questions in that domain (ex. for Desire, the sum of scores for questions 1 and 2). That total is then multiplied by the factor for that domain, which is listed in the table above. The output is the final score for that domain, and will fall within the minimum and maximum scores listed in the table above. For every domain, a lower score indicates either no sexual activity or negative outcomes in that domain, while a higher score indicates positive outcomes in that domain.
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=53 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=62 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Sexual Function
4 weeks postpartum
|
6 FSFI Score
Interval 3.9 to 7.7
|
6 FSFI Score
Interval 4.4 to 19.5
|
—
|
—
|
|
Sexual Function
8 weeks postpartum
|
18.5 FSFI Score
Interval 8.0 to 29.3
|
16 FSFI Score
Interval 4.8 to 25.4
|
—
|
—
|
|
Sexual Function
12 weeks postpartum
|
21.9 FSFI Score
Interval 8.6 to 28.2
|
19.9 FSFI Score
Interval 7.0 to 27.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At 2, 4, and 8 weeks postpartum.Population: Some subjects provided partial data: i.e. only provided responses for some days or no data at all.
To compare the total number of days of postpartum bleeding in the immediate versus standard group. This is a secondary outcome for which analysis is ongoing.
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=53 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=62 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Postpartum Bleeding Days
2 weeks postpartum
|
14 Days with bleeding
Interval 14.0 to 14.0
|
14 Days with bleeding
Interval 14.0 to 14.0
|
—
|
—
|
|
Postpartum Bleeding Days
4 weeks postpartum
|
12 Days with bleeding
Interval 7.0 to 14.0
|
14 Days with bleeding
Interval 14.0 to 14.0
|
—
|
—
|
|
Postpartum Bleeding Days
8 weeks postpartum
|
11 Days with bleeding
Interval 1.0 to 28.0
|
25 Days with bleeding
Interval 0.0 to 28.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At 8 weeks postpartumPopulation: Some subjects provided partial data or no data at all.
Using a questionnaire the investigators seek to compare participant satisfaction with the ENG implant between the immediate versus the standard group. Scale: 0= Unsatisfied, 1=Satisfied, 2=Very satisfied
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=20 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=36 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Satisfaction With the ENG Implant
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks postpartumTo compare timing of breastfeeding discontinuation through 6 months postpartum between the immediate versus the standard group.
Outcome measures
| Measure |
Standard Postpartum Insertion Group, Per Protocol
n=48 Participants
Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum)
|
Immediate Insertion Group, Per Protocol
n=51 Participants
Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention
|
Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
|
Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Changed from beginning of study from "4-6 weeks weeks postpartum" to at "least 2 weeks postpartum."
This change was decided after completing data collection for the following reasons:
1. to increase sample size in the per-protocol group;
2. to align with biologic plausibility in exposure to exogenous hormones as the "at least 2-week" interval is sufficiently remote from lactogenesis;
3. to be consistent with the American College of Obstetricians and Gynecologists recommendation for earlier intiation of postpartum visits.
|
|---|---|---|---|---|
|
Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups.
|
24 Participants
|
24 Participants
|
—
|
—
|
Adverse Events
Immediate Insertion Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Postpartum Insertion Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Family Planning Research Team
UNM Obstetrics & Gynecology
Phone: 505-205-4118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place