Trial Outcomes & Findings for Labor and Delivery Implant Insertion: A Randomized Controlled Trial (NCT NCT02866643)
NCT ID: NCT02866643
Last Updated: 2022-07-25
Results Overview
Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception. To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
95 participants
Primary outcome timeframe
Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.
Results posted on
2022-07-25
Participant Flow
Participant milestones
| Measure |
Delivery Room Insertion
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
38
|
39
|
|
Overall Study
Per Protocol Population
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Delivery Room Insertion
n=35 Participants
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
n=35 Participants
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.7 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
26.8 years
STANDARD_DEVIATION 5.3 • n=107 Participants
|
25.6 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
29 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African America
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asia
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native American, Hawaiian or Alaskan
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Declined to state
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Gestational age at delivery (weeks), median (range)
|
39.4 weeks
n=99 Participants
|
39.1 weeks
n=107 Participants
|
39.3 weeks
n=206 Participants
|
PRIMARY outcome
Timeframe: Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.Population: Per Protocol Population (received implant at protocol-specified time point)
Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception. To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery.
Outcome measures
| Measure |
Delivery Room Insertion
n=35 Participants
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
n=35 Participants
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
|---|---|---|
|
Time to Lactogenesis Stage II [Questionnaire]
|
65 hours
Standard Deviation 25.1
|
67.5 hours
Standard Deviation 35.8
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after deliveryPopulation: Participants with available data for the respective time points are included in the analysis
Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula.
Outcome measures
| Measure |
Delivery Room Insertion
n=26 Participants
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
n=28 Participants
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
|---|---|---|
|
Number of of Participants Actively Breastfeeding
Exclusive - week 2
|
13 Participants
|
16 Participants
|
|
Number of of Participants Actively Breastfeeding
Exclusive - week 4
|
10 Participants
|
8 Participants
|
|
Number of of Participants Actively Breastfeeding
Exclusive - month 3
|
9 Participants
|
6 Participants
|
|
Number of of Participants Actively Breastfeeding
Exclusive - month 6
|
7 Participants
|
3 Participants
|
|
Number of of Participants Actively Breastfeeding
Any - week 2
|
25 Participants
|
27 Participants
|
|
Number of of Participants Actively Breastfeeding
Any - week 4
|
17 Participants
|
22 Participants
|
|
Number of of Participants Actively Breastfeeding
Any - month 3
|
18 Participants
|
20 Participants
|
|
Number of of Participants Actively Breastfeeding
Any - month 6
|
13 Participants
|
13 Participants
|
|
Number of of Participants Actively Breastfeeding
Any - month 12
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: month 12Population: Participants with available data are included in the analysis.
Outcome measures
| Measure |
Delivery Room Insertion
n=15 Participants
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
n=14 Participants
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
|---|---|---|
|
Number of Participants Still With the Contraceptive Implant at Month 12.
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: month 12Population: Participants with available data are included in the analyses
Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied.
Outcome measures
| Measure |
Delivery Room Insertion
n=18 Participants
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
n=16 Participants
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
|---|---|---|
|
Number of Participants Satisfied or Very Satisfied With Implant Contraceptive
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Delivery Room Insertion
n=35 Participants
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
n=35 Participants
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
|---|---|---|
|
Number of Participants Reporting a Pregnancy Within 12 Months
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: month 3Population: Participants with available data are included in the analysis
Outcome measures
| Measure |
Delivery Room Insertion
n=31 Participants
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
|
Postpartum Insertion
n=29 Participants
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
|
|---|---|---|
|
Number of Participants Attending a Postpartum Care Visit by Month 3
|
17 Participants
|
24 Participants
|
Adverse Events
Delivery Room Insertion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Postpartum Insertion
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place