ContraceptionPhase 4NCT02416687
Etonogestrel Implant and Postpartum Insertion
A Phase 4 study testing Implanon® in people with Contraception, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Implanon®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Jan 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postpartum women aged 18 years or older who agreed to use the ENG implant as a contraceptive method,
- Body mass index (BMI) <30 kg/m2,
- Women without contraindication to breastfeeding,
- Women whose newborns were healthy, without malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for gestational age and with normal sucking ability, were included.
- The subjects had to live in Ribeirão Preto and to have breastfed a child from a previous delivery for at least 3 months.
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 (except insertion immediately postpartum) by the WHO (World Health Organization, 2009),
- Women with histories of psychiatric illness,
- Women using medications that could alter the concentration of etonogestrel,
- 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
Hospital das Clinica de Ribeirao Preto
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Immediate Post-partum Initiation of Etonogestrel-releasing Implant: a Randomized Controlled Trial on Breastfeeding Impact
The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. This study is the first assessing the impact of inserting the ENG implant immediately postpartum on the amount of milk using the gold standard method for this purpose.
Read the detailed description
What is known already: The ENG implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. This study is the first assessing the impact of inserting the ENG implant immediately postpartum on the amount of milk using the gold standard method for this purpose.
Study design, size, duration: This randomized, single-blind and controlled clinical trial evaluated 24 postpartum women and their NBs and was conducted at the Women's Health Reference Center of Ribeirão Preto, Brazil. The mother-NB pairs were evaluated for six weeks postpartum.
Participants/materials, setting, methods: Twenty-four mother-NB pairs were randomized into two groups: a) Implant group: ENG-releasing implant inserted within 48 h after delivery and b) Control group: absence of contraceptive method for six weeks after delivery. Anthropometric assessments and breastfeeding questionnaires were conducted at 4-time points of the 6-week monitoring period (at study admission and on the 14th, 29th and 43rd days after randomization). Saliva samples were collected from the mother-NB pairs prior to deuterium (D2O) dose administration. Totals of 5 g and 10 g D2O were orally administered to the postpartum women on the day of randomization (day 0) and the 29th study day, respectively. New saliva samples were collected on days 1, 2, 3, 4, 13 and 14 following intake of each D2O dose. The D2O isotope ratio was assessed in saliva samples using mass spectrometry to estimate the volume of breast milk ingested by the NB (daily average expressed as mL/day).
- Conditions
- Contraception
- Being tested
- Implanon®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implanon®Device
Also called etonogestrel-releasing implant (Implanon)
Postpartum women into whom the etonogestrel-releasing contraceptive implant was inserted in the first 48 h postpartum
| Study group | Role | What they receive |
|---|---|---|
| Implanon® | Active comparator | Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) was inserted in the first 48 h postpartum Receives: Device: Implanon® |
| Control group | No intervention | Postpartum women who used no contraceptive method in the first six weeks after delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast milk intake
The primary outcome was the amount of breast milk intake by the NBs through breastfeeding in the first six weeks after delivery
Measured: Six weeks after delivery
Secondary outcomes (2)
Exclusive breastfeeding
Rate of exclusive breastfeeding
Measured: Six weeks after delivery
Newborn weight
Weight gain by newborns in six weeks after delivery
Measured: Six weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- 24 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, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416687
- Sponsor's protocol ID
- 62798
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Post-partum Initiation of Etonogestrel-releasing Implant: a Randomized Controlled Trial on Breastfeeding Impact
- ClinicalTrials.gov ID
- NCT02416687
- Acronym / sponsor ID
- 62798
- Conditions
- Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Apr 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.
The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. This study is the first assessing the impact of inserting the ENG implant immediately postpartum on the amount of milk using the gold standard method for this purpose.
Detailed description
What is known already: The ENG implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. This study is the first assessing the impact of inserting the ENG implant immediately postpartum on the amount of milk using the gold standard method for this purpose.
Study design, size, duration: This randomized, single-blind and controlled clinical trial evaluated 24 postpartum women and their NBs and was conducted at the Women's Health Reference Center of Ribeirão Preto, Brazil. The mother-NB pairs were evaluated for six weeks postpartum.
Participants/materials, setting, methods: Twenty-four mother-NB pairs were randomized into two groups: a) Implant group: ENG-releasing implant inserted within 48 h after delivery and b) Control group: absence of contraceptive method for six weeks after delivery. Anthropometric assessments and breastfeeding questionnaires were conducted at 4-time points of the 6-week monitoring period (at study admission and on the 14th, 29th and 43rd days after randomization). Saliva samples were collected from the mother-NB pairs prior to deuterium (D2O) dose administration. Totals of 5 g and 10 g D2O were orally administered to the postpartum women on the day of randomization (day 0) and the 29th study day, respectively. New saliva samples were collected on days 1, 2, 3, 4, 13 and 14 following intake of each D2O dose. The D2O isotope ratio was assessed in saliva samples using mass spectrometry to estimate the volume of breast milk ingested by the NB (daily average expressed as mL/day).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implanon® | Active comparator | Device: Implanon®Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) was inserted in the first 48 h postpartum |
| Control group | No intervention | –Postpartum women who used no contraceptive method in the first six weeks after delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postpartum women aged 18 years or older who agreed to use the ENG implant as a contraceptive method,
- Body mass index (BMI) <30 kg/m2,
- Women without contraindication to breastfeeding,
- Women whose newborns were healthy, without malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for gestational age and with normal sucking ability, were included.
- The subjects had to live in Ribeirão Preto and to have breastfed a child from a previous delivery for at least 3 months.
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 (except insertion immediately postpartum) by the WHO (World Health Organization, 2009),
- Women with histories of psychiatric illness,
- Women using medications that could alter the concentration of etonogestrel,
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 |
|---|---|---|
| Implanon®Also: etonogestrel-releasing implant (Implanon)Postpartum women into whom the etonogestrel-releasing contraceptive implant was inserted in the first 48 h postpartum | Device | Implanon® |
Primary outcome
breast milk intake
Time frame: Six weeks after delivery
The primary outcome was the amount of breast milk intake by the NBs through breastfeeding in the first six weeks after delivery
2 secondary outcomes
Exclusive breastfeeding
Time frame: Six weeks after delivery
Newborn weight
Time frame: Six weeks after delivery
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 24 Apr 2015.
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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
University of Sao Paulo
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 Implanon® in people with Contraception, 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 5 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 24 Apr 2015. 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?
breast milk intake (time frame: Six weeks after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2015; AzTrials last refreshed its copy on 26 Oct 2026.