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ContraceptionPhase 4LACTO-RodNCT03978598

Breastfeeding Etonogestrel Implant Study

A Phase 4 study testing Etonogestrel and Nexplanon in people with Contraception, run by University of New Mexico at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get… Read more about this study

Who is it for?
Ages 13 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Etonogestrel and Nexplanon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesUnited States
Study dates
3 Jun 2019to 19 Sep 2024
Phase
Phase 4
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 13 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant women or women who have delivered vaginally and by cesarean section within 22 hours (2-hour window will allow for implant insertion by 24 hours postpartum)
  • Aged 13 and older
  • English or Spanish speakers
  • Deliver an infant at UNM Hospital at > 37 weeks gestational age
  • Intend to breastfeed
  • Desire the implant as a method for contraception
  • Agree to randomization
  • Must have a working phone (study questions to be answered through phone calls or accessed electronically by a link sent through email or text message)

Who cannot join

  • Under age 13
  • History of breast cancer (screen by past medical history)
  • History of undiagnosed vaginal bleeding (screen by past medical history)
  • Head trauma that affected pituitary function (screen by past medical history)
  • Prolactin insufficiency (screen by past medical history)
  • Previous lactation failure (defined as no lactation within 5 days postpartum)
Show all 13Show fewer
  • Any contraindication to lactation/implant use including diseases transmittable by breast milk (screen by past medical history)
  • Liver dysfunction (screen by past medical history)
  • Use of drugs that inhibit lactation (screen by medical history)
  • Sensitivity to the components of the ENG implant (screen by past medical history)
  • Contraindications to use the implant by the (US MEC) (screen by past medical history)
  • Active labor
  • Delivery at < 37 weeks gestational age

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Effect of Immediate Versus Standard Postpartum Insertion of the Contraceptive Implant on Breastfeeding Outcomes

The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.

Read the detailed description

Counseling and provision of postpartum contraception is an integral component of comprehensive reproductive healthcare. A woman's preference for contraception is paramount; early initiation of postpartum contraception may assist in optimal birth spacing promoting the wellbeing of mother and baby. Equally important is the provision of appropriate support for breastfeeding. Exclusive breastfeeding for six months with continuation beyond one year of age is recommended by the American Academy of Pediatrics (AAP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists (ACOG), and the World Health Organization (WHO).

The utilization of Long Acting Reversible Contraception (LARC's) has increased in the last decade. The etonogestrel (ENG) implant is one of the most effective LARC's and has become one of the methods used by many women in the postpartum period to prevent an unplanned pregnancy. The major advantage of immediate ENG implant insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with breastfeeding and the life changes and demands of motherhood.

Our long-term goal is to understand the impact of the ENG implant hormonal contraceptive, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that breastfeeding continuation at eight weeks postpartum is not inferior in women in the immediate insertion group of the ENG implant than in those with standard insertion and that time to lactogenesis stage II is not more than 8 hours difference between the immediate insertion and standard insertion groups.

Primary:

Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups.

Aim #2: To determine the timing of lactogenesis in both groups

Secondary:

Aim #1: To assess breastfeeding continuation and exclusivity between the immediate versus the standard group. Aim #2: To compare postpartum factors associated with discontinuing breastfeeding between the immediate versus the standard group. Aim #3: To compare participant satisfaction with postpartum contraception counseling in women enrolled in the study and in those women who opted not to enroll in the study between the immediate versus the standard group. Aim #4: To compare postpartum mood as measured by EPDS score between the immediate versus the standard group. Aim #5: To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score between the immediate versus the standard group. Aim #6: To compare the total number of days of postpartum bleeding in the immediate versus standard. Aim #7: To compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group

This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate insertion (first 24 hours after delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the ENG implant.

Conditions
Contraception
Being tested
Etonogestrel, Nexplanon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtonogestrelDrug

    Immediate v. Standard insertion.

  • NexplanonDevice

    Implant.

Study groups in NCT03978598
Study groupRoleWhat they receive
Immediate insertion groupExperimentalImmediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
Receives: Drug: Etonogestrel; Device: Nexplanon
Standard Postpartum Insertion GroupActive comparatorInsertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.
Receives: Drug: Etonogestrel; Device: Nexplanon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum

    Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.

    Measured: For the primary outcome will be the first eight weeks after delivery.

Secondary outcomes (8)

  1. Exclusive Breastfeeding

    Using a questionnaire the investigators seek to compare exclusive breastfeeding through 6 months postpartum between the immediate versus the standard group. This will be assessed by answering a trichotomous question with the following statement:

    If you are currently breastfeeding, are you:

    • Exclusively breastfeeding
    • Breastfeeding and supplementing breastfeeding with bottles of breast milk
    • Breastfeeding and supplementing breastfeeding with bottles of formula

    Measured: Up to 24 weeks postpartum.

  2. Factors Associated With Breastfeeding Discontinuation.

    Using a questionnaire the investigators seek to compare factors associated with discontinuing breastfeeding between the immediate versus the standard group.

    Subjects were asked to rate the importance of seven different factors independently, on a 4-item Likert scale from 0 = Not at all important, to 3 = Very important

    Measured: Up to 24 weeks postpartum.

  3. Satisfaction With Postpartum Contraception Counseling

    Person-Centered Contraceptive Counseling Measure (PCCC Measure) pcccmeasure.ucsf.edu

    Scale range:

    1. Poor
    2. Fair
    3. Good
    4. Very Good
    5. Excellent

    Higher values represent higher satisfaction and patient-centeredness

    Measured: At enrollment.

  4. Postpartum Mood

    To compare postpartum mood as measured by Edinburgh Postnatal Depression Scale (EPDS) score at 2, 4, and 8 weeks postpartum. Results reported as a total score ranging from 0-30, no subscale scores. A higher scale represents a worse outcome, ie. is more predictive of a depressive disorder including postpartum depression.

    Measured: At 2, 4, and 8 weeks postpartum.

  5. Sexual Function

    To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score. Minimum score 2, Maximum score 36. Subscales are combined by first totaling the scores for the individual questions in that domain (ex. for Desire, the sum of scores for questions 1 and 2). That total is then multiplied by the factor for that domain, which is listed in the table above. The output is the final score for that domain, and will fall within the minimum and maximum scores listed in the table above.

    For every domain, a lower score indicates either no sexual activity or negative outcomes in that domain, while a higher score indicates positive outcomes in that domain.

    Measured: At 4, 8, and 12 weeks postpartum

  6. Postpartum Bleeding Days

    To compare the total number of days of postpartum bleeding in the immediate versus standard group.

    This is a secondary outcome for which analysis is ongoing.

    Measured: At 2, 4, and 8 weeks postpartum.

  7. Satisfaction With the ENG Implant

    Using a questionnaire the investigators seek to compare participant satisfaction with the ENG implant between the immediate versus the standard group.

    Scale: 0= Unsatisfied, 1=Satisfied, 2=Very satisfied

    Measured: At 8 weeks postpartum

  8. Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups.

    To compare timing of breastfeeding discontinuation through 6 months postpartum between the immediate versus the standard group.

    Measured: Up to 24 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2019
  2. Study start3 Jun 2019
  3. Primary completion4 Jun 2024
  4. Study completion19 Sep 2024

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03978598
Sponsor's protocol ID
19-049
Acronym
LACTO-Rod
Status last verified
Nov 2025
First submitted
24 May 2019
Last updated
28 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • American College of Obstetricians and Gynecologists. ACOG committee opinion 736, Optimizing Postpartum Care. Washington, DC: American College of Obstetricians and Gynecologists. 2018 May; 131(5):140-150.

  • Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.

    PubMed 22371471

  • AAFP Releases Position Paper on Breastfeeding Am Fam Physician. 2015 Jan 1;91(1):56-57.

  • ACOG Committee Opinion No. 756: Optimizing Support for Breastfeeding as Part of Obstetric Practice. Obstet Gynecol. 2018 Oct;132(4):e187-e196. doi: 10.1097/AOG.0000000000002890.

    PubMed 30247365

  • Infant and Young Child Feeding: Model Chapter for Textbooks for Medical Students and Allied Health Professionals. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK148965/

    PubMed 23905206

  • CDC. 2018 Breastfeeding Report Card [Internet]. Centers for Disease Control and Prevention. 2018 [cited 2018 Nov 10]. Available from: https://www.cdc.gov/breastfeeding/data/reportcard.htm

  • Chapman DJ, Perez-Escamilla R. Maternal perception of the onset of lactation is a valid, public health indicator of lactogenesis stage II. J Nutr. 2000 Dec;130(12):2972-80. doi: 10.1093/jn/130.12.2972.

    PubMed 11110856

  • Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016 Jul 29;65(3):1-103. doi: 10.15585/mmwr.rr6503a1.

    PubMed 27467196

  • Cunningham FG, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, et al. Contraception. In: Williams Obstetrics, 25e [Internet]. New York, NY: McGraw-Hill Education; 2018 [cited 2018 Nov 10].

  • Turok DK, Leeman L, Sanders JN, Thaxton L, Eggebroten JL, Yonke N, Bullock H, Singh R, Gawron LM, Espey E. Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial. Am J Obstet Gynecol. 2017 Dec;217(6):665.e1-665.e8. doi: 10.1016/j.ajog.2017.08.003. Epub 2017 Aug 23.

    PubMed 28842126

  • Sothornwit J, Werawatakul Y, Kaewrudee S, Lumbiganon P, Laopaiboon M. Immediate versus delayed postpartum insertion of contraceptive implant for contraception. Cochrane Database Syst Rev. 2017 Apr 22;4(4):CD011913. doi: 10.1002/14651858.CD011913.pub2.

    PubMed 28432791

  • 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 21508750

  • Phillips SJ, Tepper NK, Kapp N, Nanda K, Temmerman M, Curtis KM. Progestogen-only contraceptive use among breastfeeding women: a systematic review. Contraception. 2016 Sep;94(3):226-52. doi: 10.1016/j.contraception.2015.09.010. Epub 2015 Sep 26.

    PubMed 26410174

  • Bryant AG, Bauer AE, Stuart GS, Levi EE, Zerden ML, Danvers A, Garrett JM. Etonogestrel-Releasing Contraceptive Implant for Postpartum Adolescents: A Randomized Controlled Trial. J Pediatr Adolesc Gynecol. 2017 Jun;30(3):389-394. doi: 10.1016/j.jpag.2016.08.003. Epub 2016 Aug 22.

    PubMed 27561981

  • Espey E, Ogburn T, Leeman L, Singh R, Ostrom K, Schrader R. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):5-13. doi: 10.1097/AOG.0b013e31823dc015.

    PubMed 22143258

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Etonogestrel and Nexplanon in people with Contraception, run by University of New Mexico at 2 sites 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 8 inclusion and 13 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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?

Yes. Results are posted in the registry (first posted 8 Sep 2025). 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 With Continuation of Breastfeeding at 8 Weeks Postpartum (time frame: For the primary outcome will be the first eight weeks after delivery.). 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 NCT03978598, which also lists 28 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 28 Nov 2025.

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