A Phase 3 interventional study of Etonogestrel-Immediate and Etonogestrel-Delayed in Postpartum Contraception and Family Planning, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Stanford University · Phase 3, Interventional, and Prevention
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.
289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.
This study's enrollment of 95 is close to the median of 97 across 228 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
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Exclusion Criteria:
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Drug: Etonogestrel-Immediate
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Drug: Etonogestrel-Delayed
The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
Also known as: Nexplanon, Contraceptive Implant
The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
Also known as: Nexplanon, Contraceptive Implant
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.
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
Number of Participants Still With the Contraceptive Implant at Month 12.
Time frame: month 12
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
Number of Participants Reporting a Pregnancy Within 12 Months
Time frame: 12 months
Number of Participants Attending a Postpartum Care Visit by Month 3
Time frame: month 3
| Milestone | Delivery Room Insertion | Postpartum Insertion |
|---|---|---|
| Started | 48 | 47 |
| Intent-to-treat (itt) population | 38 | 39 |
| Per protocol population | 35 | 35 |
| Completed | 35 | 35 |
| Not completed | 13 | 12 |
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.
| hours | Delivery Room Insertion | Postpartum Insertion |
|---|---|---|
| Time to Lactogenesis Stage II [Questionnaire] | 65 ± 25.1 | 67.5 ± 35.8 |
Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula.
| Participants | Delivery Room Insertion | Postpartum Insertion |
|---|---|---|
| Exclusive - week 2 | 13 | 16 |
| Exclusive - week 4 | 10 | 8 |
| Exclusive - month 3 | 9 | 6 |
| Exclusive - month 6 | 7 | 3 |
| Any - week 2 | 25 | 27 |
| Any - week 4 | 17 | 22 |
| Any - month 3 | 18 | 20 |
| Any - month 6 | 13 | 13 |
| Any - month 12 | 5 | 7 |
| Participants | Delivery Room Insertion | Postpartum Insertion |
|---|---|---|
| Number of Participants Still With the Contraceptive Implant at Month 12. | 14 | 12 |
Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied.
| Participants | Delivery Room Insertion | Postpartum Insertion |
|---|---|---|
| Number of Participants Satisfied or Very Satisfied With Implant Contraceptive | 16 | 10 |
| Participants | Delivery Room Insertion | Postpartum Insertion |
|---|---|---|
| Number of Participants Reporting a Pregnancy Within 12 Months | 1 | 1 |
| Participants | Delivery Room Insertion | Postpartum Insertion |
|---|---|---|
| Number of Participants Attending a Postpartum Care Visit by Month 3 | 17 | 24 |
Collected over Time of enrollment through the discharge from the hospital (up to 10 days post-delivery).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Delivery Room Insertion | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Postpartum Insertion | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
Per Protocol Population (received implant at protocol-specified time point)
| Age, Continuous(years) | Delivery Room Insertion | Postpartum Insertion | Total |
|---|---|---|---|
| Mean | 24.7 ± 5.3 | 26.8 ± 5.3 | 25.6 ± 5.3 |
| Sex: Female, Male(Participants) | Delivery Room Insertion | Postpartum Insertion | Total |
|---|---|---|---|
| Female | 35 | 35 | 70 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Delivery Room Insertion | Postpartum Insertion | Total |
|---|---|---|---|
| Race — White | 29 | 27 | 56 |
| Race — Black or African America | 2 | 2 | 4 |
| Race — Asia | 0 | 2 | 2 |
| Race — Native American, Hawaiian or Alaskan | 1 | 2 | 3 |
| Race — Declined to state | 3 | 2 | 5 |
| Region of Enrollment(Participants) | Delivery Room Insertion | Postpartum Insertion | Total |
|---|---|---|---|
| United States | 35 | 35 | 70 |
| Gestational age at delivery (weeks), median (range)(weeks) | Delivery Room Insertion | Postpartum Insertion | Total |
|---|---|---|---|
| Median | 39.4 (37 to 41) | 39.1 (33 to 41) | 39.3 (35 to 41) |
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Etonogestrel