An interventional study of Etonogestrel Contraceptive Implant in Contraception, Breastfeeding and Postpartum Contraception, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to female participants aged 17 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Prevention
The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period
Immediate postpartum initiation of the etonogestrel contraceptive implant has been proven to decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy women with term infants initiation of the contraceptive implant 1-3 days postpartum does not appear to have any adverse effects on lactogenesis or breastfeeding continuation. However, no high quality study to date has examined the effects of progestin-only contraception in women known to be at risk for low milk supply, including women with a premature delivery, obesity, polycystic ovarian syndrome, diabetes, or a prior history of low milk supply.
The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration. This will be a three-armed randomized non-inferiority study of women who plan to breastfeed, have known risk factors for low milk supply, and who intend to use the contraceptive implant postpartum. Women will be randomized to one of three groups for the timing of contraceptive implant placement: within 30 minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. Women will be assessed at 6 weeks, 3 months and 6 months postpartum. Outcomes will include time to Lactogenesis Stage II, duration and exclusivity of breastfeeding, continuation of and satisfaction with the contraceptive implant, and side effects, including bleeding patterns, associated with the implant.
Findings from this trial will be used by clinicians, hospital systems, and policy makers working to expand access to immediate postpartum implants while supporting women in meeting their breastfeeding goals.
289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.
This study's enrollment of 155 is above the median of 97 across 228 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.
Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.
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The presence of at least one of the following conditions known to be a risk factor for low milk supply:
Exclusion Criteria:
contraceptive implant placed within 30 minutes of placental delivery
Device: Etonogestrel Contraceptive Implant
Contraceptive Implant placed 1-3 days postpartum
Device: Etonogestrel Contraceptive Implant
Contraceptive Implant placed 6 or more weeks postpartum
Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Also known as: Nexplanon
Number of Participants Breastfeeding at 6 Months
Exclusive Breastfeeding at 6 months
Time frame: 6 months postpartum
Time to Lactogenesis Stage II
Difference in time to Lactogenesis Stage II
Time frame: 1-5 days postpartum
Vaginal Bleeding
Number of Participants that reported heavy bleeding at 6 months postpartum
Time frame: 0-6 months postpartum
Satisfaction With Contraceptive Implant
Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum
Time frame: 0-6 months postpartum
| Milestone | Postplacental | Immediate Postpartum | Delayed |
|---|---|---|---|
| Started | 51 | 52 | 52 |
| Completed | 51 | 52 | 52 |
| Not completed | 0 | 0 | 0 |
Exclusive Breastfeeding at 6 months
| Participants | Postplacental | Immediate Postpartum | Delayed |
|---|---|---|---|
| Number of Participants Breastfeeding at 6 Months | 6 | 4 | 6 |
Difference in time to Lactogenesis Stage II
| hours | Postplacental | Immediate Postpartum | Delayed |
|---|---|---|---|
| Time to Lactogenesis Stage II | 66.9 ± 27.2 | 62.1 ± 29.0 | 57.3 ± 21.7 |
Number of Participants that reported heavy bleeding at 6 months postpartum
| Participants | Postplacental | Immediate Postpartum | Delayed |
|---|---|---|---|
| Vaginal Bleeding | 7 | 6 | 4 |
Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum
| score on a scale | Postplacental | Immediate Postpartum | Delayed |
|---|---|---|---|
| Satisfaction With Contraceptive Implant | 8.41 ± 2.01 | 8.14 ± 2.47 | 8.69 ± 1.60 |
Collected over Every 3 months from initiation to 6 months post-partum. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Postplacental | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Immediate Postpartum | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Delayed | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Postplacental | Immediate Postpartum | Delayed | Total |
|---|---|---|---|---|
| Mean | 27 ± 4.5 | 27 ± 4.6 | 27 ± 4.8 | 27 ± 4.6 |
| Sex: Female, Male(Participants) | Postplacental | Immediate Postpartum | Delayed | Total |
|---|---|---|---|---|
| Female | 51 | 52 | 52 | 155 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Postplacental | Immediate Postpartum | Delayed | Total |
|---|---|---|---|---|
| Hispanic or Latino | 32 | 32 | 31 | 95 |
| Not Hispanic or Latino | 14 | 17 | 18 | 49 |
| Unknown or Not Reported | 5 | 3 | 3 | 11 |
| Race (NIH/OMB)(Participants) | Postplacental | Immediate Postpartum | Delayed | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 25 | 18 | 22 | 65 |
| White | 9 | 8 | 6 | 23 |
| More than one race | 17 | 24 | 24 | 65 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 |
Documents are hosted by the registry — open the source record to download them.
The record gives a start of Nov 2016, a primary completion of Apr 2021 and a completion of Sep 2021. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2022, 1 year 6 months after primary completion.
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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