Family Planning, Postpartum Contraception
Conditions
Keywords
contraceptive implant, postpartum contraception, breastfeeding and contraception
Brief summary
A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82 consenting women will be randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room or insertion of the implant following delivery in postpartum room and prior to medical discharge (24-48 hours following delivery). Participants complete a questionnaire that asks questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire also includes questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.
Interventions
DRUGEtonogestrel-Immediate
The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
DRUGEtonogestrel-Delayed
The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women who are patients of the Stanford University Obstetrics service * Pregnant women who delivery a healthy infant, regardless of gestational age. * Intend to breastfeed * Desire the contraceptive implant as their method of contraception * Agree to be randomized to delivery room vs. postpartum ward insertion
Exclusion criteria
* Not English or Spanish speaking * Allergy or Contraindication to contraceptive implant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Lactogenesis Stage II [Questionnaire] | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of of Participants Actively Breastfeeding | 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery | Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula. |
| Number of Participants Still With the Contraceptive Implant at Month 12. | month 12 | — |
| Number of Participants Satisfied or Very Satisfied With Implant Contraceptive | month 12 | Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied. |
| Number of Participants Reporting a Pregnancy Within 12 Months | 12 months | — |
| Number of Participants Attending a Postpartum Care Visit by Month 3 | month 3 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 35 |
| 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. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Delivery Room Insertion | Postpartum Insertion | Total |
|---|---|---|---|
| Age, Continuous | 24.7 years STANDARD_DEVIATION 5.3 | 26.8 years STANDARD_DEVIATION 5.3 | 25.6 years STANDARD_DEVIATION 5.3 |
| Gestational age at delivery (weeks), median (range) | 39.4 weeks | 39.1 weeks | 39.3 weeks |
| Race/Ethnicity, Customized Race Asia | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African America | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Declined to state | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Native American, Hawaiian or Alaskan | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 29 Participants | 27 Participants | 56 Participants |
| Region of Enrollment United States | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 47 |
| other Total, other adverse events | 0 / 48 | 0 / 47 |
| serious Total, serious adverse events | 0 / 48 | 0 / 47 |
Outcome results
Primary
Time to Lactogenesis Stage II [Questionnaire]
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delivery Room Insertion | Time to Lactogenesis Stage II [Questionnaire] | 65 hours | Standard Deviation 25.1 |
| Postpartum Insertion | Time to Lactogenesis Stage II [Questionnaire] | 67.5 hours | Standard Deviation 35.8 |
Secondary
Number of of Participants Actively Breastfeeding
Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula.
Time frame: 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery
Population: Participants with available data for the respective time points are included in the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Exclusive - week 4 | 10 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Any - week 4 | 17 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Exclusive - month 6 | 7 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Any - month 3 | 18 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Exclusive - month 3 | 9 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Any - month 6 | 13 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Any - week 2 | 25 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Any - month 12 | 5 Participants |
| Delivery Room Insertion | Number of of Participants Actively Breastfeeding | Exclusive - week 2 | 13 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Any - month 12 | 7 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Exclusive - week 2 | 16 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Exclusive - week 4 | 8 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Exclusive - month 3 | 6 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Exclusive - month 6 | 3 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Any - week 2 | 27 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Any - week 4 | 22 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Any - month 3 | 20 Participants |
| Postpartum Insertion | Number of of Participants Actively Breastfeeding | Any - month 6 | 13 Participants |
Secondary
Number of Participants Attending a Postpartum Care Visit by Month 3
Time frame: month 3
Population: Participants with available data are included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delivery Room Insertion | Number of Participants Attending a Postpartum Care Visit by Month 3 | 17 Participants |
| Postpartum Insertion | Number of Participants Attending a Postpartum Care Visit by Month 3 | 24 Participants |
Secondary
Number of Participants Reporting a Pregnancy Within 12 Months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delivery Room Insertion | Number of Participants Reporting a Pregnancy Within 12 Months | 1 Participants |
| Postpartum Insertion | Number of Participants Reporting a Pregnancy Within 12 Months | 1 Participants |
Secondary
Number of Participants Satisfied or Very Satisfied With Implant Contraceptive
Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied.
Time frame: month 12
Population: Participants with available data are included in the analyses
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delivery Room Insertion | Number of Participants Satisfied or Very Satisfied With Implant Contraceptive | 16 Participants |
| Postpartum Insertion | Number of Participants Satisfied or Very Satisfied With Implant Contraceptive | 10 Participants |
Secondary
Number of Participants Still With the Contraceptive Implant at Month 12.
Time frame: month 12
Population: Participants with available data are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delivery Room Insertion | Number of Participants Still With the Contraceptive Implant at Month 12. | 14 Participants |
| Postpartum Insertion | Number of Participants Still With the Contraceptive Implant at Month 12. | 12 Participants |