ContraceptionPhase 4NCT02469454
Effect of t of the Etonogestrel Releasing Implant on Infant Growth and Development
A Phase 4 study testing early insertion and conventional insertion in people with Contraception and Newborn, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to assess whether there is change in the growth and development of newborns whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48 hours of delivery compared with those with standard implant insertion (6 week postpartum). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Newborn, Child Development
- What is being tested?
- early insertion and conventional insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who desire to use the ENG implant as a contraceptive method and desire to breastfeed her newborn for ate least 3 months;
- With no contraindication to breastfeeding, whose newborn is healthy, without malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for gestational age and with normal sucking ability
Who cannot join
- Tobacco smokers, drug addicts or alcoholics;
- Women with educational levels lower than 5 years;
- Women with clinical conditions considered category 3 and 4 for implant use by the WHO;
- Women with histories of psychiatric illness;
- Women using medications that could alter the concentration of ENG,
- Women with known allergies to the local anesthetic lidocaine (used to place the implant);
- Women who wanted to keep their cyclic menstrual bleeding
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Sao Paulo University
Ribeirão Preto, São Paulo, 14048900
About this study
Official title: Effect of the Immediately Postpartum Insertion of the Etonogestrel Releasing Implant on Infant Growth and Development
This study aims to assess whether there is change in the growth and development of newborns whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48 hours of delivery compared with those with standard implant insertion (6 week postpartum).
- Conditions
- Contraception, Newborn, Child Development, Growth
- Being tested
- early insertion, conventional insertion
- Keywords
- etonogestrel-implant, newborn, growth, Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early insertionDrug
Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum.
conventional insertionDrug
Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 6 week of delivery.
| Study group | Role | What they receive |
|---|---|---|
| early insertion | Experimental | Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions. Receives: Drug: early insertion |
| conventional insertion | Active comparator | Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted after 6 week of the delivery. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions. Receives: Drug: conventional insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal growth
Measured: 12 months
Secondary outcomes (1)
child development
Child development will be evaluated by Bayley III Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Sales Vieira, University of Sao Paulo
- Investigators
- Carolina S Vieira, MD, PhD, Principal investigator, Sao Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469454
- Sponsor's protocol ID
- ENG-implant-02
- Status last verified
- Nov 2016
- First submitted
- 9 Jun 2015
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Nadai MN, Martins Linhares MB, de Lima Rodrigues Sisdeli JC, de Melo Pereira do Carmo LS, Braga GC, Ferreira LS, Quintana SM, Vieira CS. Effects of the immediate postpartum insertion of the etonogestrel implant on the development of breastfed infants: Results from a randomized controlled trial. Int J Gynaecol Obstet. 2025 Dec;171(3):1223-1230. doi: 10.1002/ijgo.70291. Epub 2025 Jun 9.
PubMed 40488538Vieira CS, de Nadai MN, de Melo Pereira do Carmo LS, Braga GC, Infante BF, Stifani BM, Ferriani RA, Quintana SM. Timing of postpartum etonogestrel-releasing implant insertion and bleeding patterns, weight change, 12-month continuation and satisfaction rates: a randomized controlled trial. Contraception. 2019 Oct;100(4):258-263. doi: 10.1016/j.contraception.2019.05.007. Epub 2019 May 27.
PubMed 31145885Carmo LSMP, Braga GC, Ferriani RA, Quintana SM, Vieira CS. Timing of Etonogestrel-Releasing Implants and Growth of Breastfed Infants: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):100-107. doi: 10.1097/AOG.0000000000002092.
PubMed 28594758
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Immediately Postpartum Insertion of the Etonogestrel Releasing Implant on Infant Growth and Development
- ClinicalTrials.gov ID
- NCT02469454
- Acronym / sponsor ID
- ENG-implant-02
- Conditions
- Contraception, Newborn, Child Development, Growth
- Keywords
- etonogestrel-implant, newborn, growth, Child Development
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess whether there is change in the growth and development of newborns whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48 hours of delivery compared with those with standard implant insertion (6 week postpartum).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early insertion | Experimental | Drug: early insertionPostpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions. |
| conventional insertion | Active comparator | Drug: conventional insertionPostpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted after 6 week of the delivery. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who desire to use the ENG implant as a contraceptive method and desire to breastfeed her newborn for ate least 3 months;
- With no contraindication to breastfeeding, whose newborn is healthy, without malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for gestational age and with normal sucking ability
Key exclusion criteria (7 listed)
- Tobacco smokers, drug addicts or alcoholics;
- Women with educational levels lower than 5 years;
- Women with clinical conditions considered category 3 and 4 for implant use by the WHO;
- Women with histories of psychiatric illness;
- Women using medications that could alter the concentration of ENG,
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 |
|---|---|---|
| early insertionPostpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum. | Drug | early insertion |
| conventional insertionPostpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 6 week of delivery. | Drug | conventional insertion |
Primary outcome
neonatal growth
Time frame: 12 months
1 secondary outcome
child development
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Derived from this study: PubMed 40488538de Nadai MN, Martins Linhares MB, de Lima Rodrigues Sisdeli JC, de Melo Pereira do Carmo LS, Braga GC, Ferreira LS, Quintana SM, Vieira CS. Effects of the immediate postpartum insertion of the etonogestrel implant on the development of breastfed infants: Results from a randomized controlled trial. Int J Gynaecol Obstet. 2025 Dec;171(3):1223-1230. doi: 10.1002/ijgo.70291. Epub 2025 Jun 9.
- Derived from this study: PubMed 31145885Vieira CS, de Nadai MN, de Melo Pereira do Carmo LS, Braga GC, Infante BF, Stifani BM, Ferriani RA, Quintana SM. Timing of postpartum etonogestrel-releasing implant insertion and bleeding patterns, weight change, 12-month continuation and satisfaction rates: a randomized controlled trial. Contraception. 2019 Oct;100(4):258-263. doi: 10.1016/j.contraception.2019.05.007. Epub 2019 May 27.
- Derived from this study: PubMed 28594758Carmo LSMP, Braga GC, Ferriani RA, Quintana SM, Vieira CS. Timing of Etonogestrel-Releasing Implants and Growth of Breastfed Infants: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):100-107. doi: 10.1097/AOG.0000000000002092.
- Individual participant dataSharing planned: No
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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.
Carolina S Vieira, MD, PhD principal investigator
Sao Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing early insertion and conventional insertion in people with Contraception and Newborn, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 7 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 3 Nov 2016. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
neonatal growth (time frame: 12 months). 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 NCT02469454, which also lists 3 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 3 Nov 2016.