ContraceptionNCT02866279
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
A study testing Etonogestrel Contraceptive Implant in people with Contraception and Breastfeeding, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 17 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Breastfeeding, Postpartum Contraception
- What is being tested?
- Etonogestrel Contraceptive Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 11Show fewer
- Expected delivery prior to 34 weeks
- Obesity (pre-pregnancy BMI >35)
- Polycystic Ovarian Syndrome
- Diabetes (gestational or pre-gestational)
- Self-reported difficulty with low milk supply in past
Who cannot join
- Not English or Spanish speaking
- Allergy or Contraindication to contraceptive implant
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10034
About this study
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
Read the detailed description
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.
- Conditions
- Contraception, Breastfeeding, Postpartum Contraception
- Being tested
- Etonogestrel Contraceptive Implant
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel Contraceptive ImplantDevice
Also called Nexplanon
Women will be randomized to the TIMING of implant placement
| Study group | Role | What they receive |
|---|---|---|
| Postplacental | Experimental | contraceptive implant placed within 30 minutes of placental delivery Receives: Device: Etonogestrel Contraceptive Implant |
| Immediate Postpartum | Experimental | Contraceptive Implant placed 1-3 days postpartum Receives: Device: Etonogestrel Contraceptive Implant |
| Delayed | Active comparator | Contraceptive Implant placed 6 or more weeks postpartum Receives: Device: Etonogestrel Contraceptive Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Breastfeeding at 6 Months
Exclusive Breastfeeding at 6 months
Measured: 6 months postpartum
Time to Lactogenesis Stage II
Difference in time to Lactogenesis Stage II
Measured: 1-5 days postpartum
Secondary outcomes (2)
Vaginal Bleeding
Number of Participants that reported heavy bleeding at 6 months postpartum
Measured: 0-6 months postpartum
Satisfaction With Contraceptive Implant
Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum
Measured: 0-6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startNov 2016
- Primary completion7 Apr 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Erika Levi, MD, MPH, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866279
- Sponsor's protocol ID
- 2016-6852
- Status last verified
- Oct 2022
- First submitted
- 7 Aug 2016
- Last updated
- 1 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 21508750Sothornwit 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.
PubMed 36302159
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02866279
- Acronym / sponsor ID
- 2016-6852
- Conditions
- Contraception, Breastfeeding, Postpartum Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Nov 2016
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Posted 1 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postplacental | Experimental | Device: Etonogestrel Contraceptive Implantcontraceptive implant placed within 30 minutes of placental delivery |
| Immediate Postpartum | Experimental | Device: Etonogestrel Contraceptive ImplantContraceptive Implant placed 1-3 days postpartum |
| Delayed | Active comparator | Device: Etonogestrel Contraceptive ImplantContraceptive Implant placed 6 or more weeks postpartum |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (2 listed)
- Not English or Spanish speaking
- Allergy or Contraindication to contraceptive implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel Contraceptive ImplantAlso: NexplanonWomen will be randomized to the TIMING of implant placement | Device | Delayed, Immediate Postpartum, Postplacental |
Primary outcome
Number of Participants Breastfeeding at 6 Months
Time frame: 6 months postpartum
Exclusive Breastfeeding at 6 months
Time to Lactogenesis Stage II
Time frame: 1-5 days postpartum
Difference in time to Lactogenesis Stage II
2 secondary outcomes
Vaginal Bleeding
Time frame: 0-6 months postpartum
Satisfaction With Contraceptive Implant
Time frame: 0-6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21508750Gurtcheff 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.
- Derived from this study: PubMed 36302159Sothornwit 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Levi, MD, MPH principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etonogestrel Contraceptive Implant in people with Contraception and Breastfeeding, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Breastfeeding at 6 Months (time frame: 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02866279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.