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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postplacental | Experimental | contraceptive implant placed within 30 minutes of placental delivery |
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| Immediate Postpartum | Experimental | Contraceptive Implant placed 1-3 days postpartum |
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| Delayed | Active Comparator | Contraceptive Implant placed 6 or more weeks postpartum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel Contraceptive Implant | Device | Women will be randomized to the TIMING of implant placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Breastfeeding at 6 Months | Exclusive Breastfeeding at 6 months | 6 months postpartum |
| Time to Lactogenesis Stage II | Difference in time to Lactogenesis Stage II | 1-5 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Bleeding | Number of Participants that reported heavy bleeding at 6 months postpartum | 0-6 months postpartum |
| Satisfaction With Contraceptive Implant | Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum |
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Inclusion Criteria:
Live pregnancy of at least 24 weeks gestation
Intention to use a contraceptive implant postpartum
17 years of age or older
English or Spanish speaking
Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible)
The presence of at least one of the following conditions known to be a risk factor for low milk supply:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika Levi, MD, MPH | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10034 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21508750 | Background | Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial. Obstet Gynecol. 2011 May;117(5):1114-1121. doi: 10.1097/AOG.0b013e3182165ee8. | |
| 36302159 | Derived | Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Postplacental | contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement |
| FG001 | Immediate Postpartum |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2022 |
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| 0-6 months postpartum |
Contraceptive Implant placed 1-3 days postpartum
Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement
| FG002 | Delayed | Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Postplacental | contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement |
| BG001 | Immediate Postpartum | Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement |
| BG002 | Delayed | Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Breastfeeding at 6 Months | Exclusive Breastfeeding at 6 months | Posted | Count of Participants | Participants | 6 months postpartum |
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| Primary | Time to Lactogenesis Stage II | Difference in time to Lactogenesis Stage II | Posted | Mean | Standard Deviation | hours | 1-5 days postpartum |
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| Secondary | Vaginal Bleeding | Number of Participants that reported heavy bleeding at 6 months postpartum | Posted | Count of Participants | Participants | 0-6 months postpartum |
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| Secondary | Satisfaction With Contraceptive Implant | Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum | Posted | Mean | Standard Deviation | score on a scale | 0-6 months postpartum |
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Every 3 months from initiation to 6 months post-partum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Postplacental | contraceptive implant placed within 30 minutes of placental delivery Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement | 0 | 51 | 0 | 51 | 0 | 51 |
| EG001 | Immediate Postpartum | Contraceptive Implant placed 1-3 days postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement | 0 | 52 | 0 | 52 | 0 | 52 |
| EG002 | Delayed | Contraceptive Implant placed 6 or more weeks postpartum Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement | 0 | 52 | 0 | 52 | 0 | 52 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erika Levi | Montefiore Medical Center | 7184058200 | elevi@montefiore.org |
| Sep 12, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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