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CompletedNCT03978598LACTO-RodUpdated Nov 28, 2025Results posted

Breastfeeding Etonogestrel Implant Study

A Phase 4 interventional study of Etonogestrel and Nexplanon in Contraception, sponsored by University of New Mexico. Completed at 2 sites in United States. Open to female participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by University of New Mexico · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
13 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Contraception
03

In context

Lead sponsor

University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Immediate insertion group

    Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.

    Drug: Etonogestrel · Device: Nexplanon

  • Active comparator
    Standard Postpartum Insertion Group

    Insertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.

    Drug: Etonogestrel · Device: Nexplanon

Interventions

  • DrugEtonogestrel

    Immediate v. Standard insertion.

  • DeviceNexplanon

    Implant.

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: Up to 24 weeks postpartum

07

Results

Posted Sep 8, 2025

Participant flow

Participant flow — Overall Study
MilestoneImmediate Insertion GroupStandard Postpartum Insertion Group
Started7872
Modified intention to treat6957
Completed6253
Not completed1619

Outcome measures

PrimaryNumber 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.

Time frame:
For the primary outcome will be the first eight weeks after delivery.
Reported as:
Count of participants · Participants
Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum
ParticipantsImmediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treatStandard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treatImmediate: Implant Placed Within 24 Hours Postpartum -- Per ProtocolStandard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol
Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum54454843
Statistical analysis
  • Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol vs Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol · Risk difference (rd): 3.7
SecondaryExclusive 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

Time frame:
Up to 24 weeks postpartum.
Reported as:
Count of participants · Participants
Exclusive Breastfeeding
ParticipantsImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
Exclusive Breastfeeding139
SecondaryFactors 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

Time frame:
Up to 24 weeks postpartum.
Reported as:
Median · score on a Likert scale
Factors Associated With Breastfeeding Discontinuation.
score on a Likert scaleImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
Baby had trouble sucking or latching0.5 (0 to 2.75)3 (0 to 3)
Baby got sick0 (0 to 0)0 (0 to 0.25)
I was sick0 (0 to 0)0 (0 to 2)
Provider said baby was underweight0 (0 to 0)0 (0 to 1.25)
Insufficient milk2 (0 to 3)2 (0 to 3)
I had trouble; breast issues0 (0 to 0)1.5 (0 to 3)
I quit breastfeeding; life issues2 (0 to 2)0 (0 to 2)
Statistical analysis
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.221
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.786
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.064
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.044
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.666
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.006
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.476
SecondarySatisfaction 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

Time frame:
At enrollment.
Reported as:
Median · score on a scale
Satisfaction With Postpartum Contraception Counseling
score on a scaleImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
Respecting me as a person5 (5 to 5)5 (5 to 5)
Letting me say what mattered to me about my birth control method5 (4 to 5)5 (4 to 5)
Taking my preferences about my birth control seriously5 (4 to 5)5 (5 to 5)
Giving me enough information to make the best decision about my birth control method5 (5 to 5)5 (4 to 5)
Statistical analysis
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.717
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.808
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.967
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.826
SecondaryPostpartum 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.

Time frame:
At 2, 4, and 8 weeks postpartum.
Reported as:
Median · EPDS Score
Postpartum Mood
EPDS ScoreImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
2 weeks postpartum2 (1 to 5)1 (1 to 8)
4 weeks postpartum2 (1 to 6)4 (1 to 7)
8 weeks postpartum3 (1 to 6)4 (1 to 7)
Statistical analysis
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.264
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.414
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.482
SecondarySexual 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.

Time frame:
At 4, 8, and 12 weeks postpartum
Reported as:
Median · FSFI Score
Sexual Function
FSFI ScoreImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
4 weeks postpartum6 (4.4 to 19.5)6 (3.9 to 7.7)
8 weeks postpartum16 (4.8 to 25.4)18.5 (8 to 29.3)
12 weeks postpartum19.9 (7 to 27.9)21.9 (8.6 to 28.2)
Statistical analysis
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.583
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.062
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.705
SecondaryPostpartum 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.

Time frame:
At 2, 4, and 8 weeks postpartum.
Reported as:
Median · Days with bleeding
Postpartum Bleeding Days
Days with bleedingImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
2 weeks postpartum14 (14 to 14)14 (14 to 14)
4 weeks postpartum14 (14 to 14)12 (7 to 14)
8 weeks postpartum25 (0 to 28)11 (1 to 28)
Statistical analysis
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.60
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.07
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.36
SecondarySatisfaction 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

Time frame:
At 8 weeks postpartum
Reported as:
Median · score on a scale
Satisfaction With the ENG Implant
score on a scaleImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
Satisfaction With the ENG Implant1 (1 to 1)1 (1 to 2)
Statistical analysis
  • Immediate Insertion Group, Per Protocol vs Standard Postpartum Insertion Group, Per Protocol · Wilcoxon (Mann-Whitney) · p = 0.0376
SecondaryTiming 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.

Time frame:
Up to 24 weeks postpartum
Reported as:
Count of participants · Participants
Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups.
ParticipantsImmediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per Protocol
Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups.2424

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Immediate Insertion Group0/78 (0%)0/78 (0%)0/78 (0%)
Standard Postpartum Insertion Group1/72 (1.4%)0/72 (0%)0/72 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Mean28.1 ± 5.527.2 ± 5.327.7 ± 5.4
Sex: Female, Male
Sex: Female, Male(Participants)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Female6253115
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Hispanic or Latina444488
American Indian or Alaska Native4711
Black or African American213
White342660
Other151530
Parity
Parity(Parity)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Mean2 (1 to 3)1 (1 to 2)2 (1 to 3)
Previously used implant
Previously used implant(Participants)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Count of participants261642
Previously breastfed
Previously breastfed(Participants)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Count of participants332356
Planning to breastfeed more than 6 months
Planning to breastfeed more than 6 months(Participants)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Count of participants514798
Delivery mode
Delivery mode(Participants)Immediate Insertion Group, Per ProtocolStandard Postpartum Insertion Group, Per ProtocolTotal
Vaginal513990
Cesarean91322
Operative vaginal213

2 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
09

References and documents

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 ↗
  • Acog.org. (2018). Medicaid Reimbursement for Postpartum LARC by State - ACOG. [online] Available at: https://www.acog.org/About-ACOG/ACOG-Departments/Long-Acting-Reversible-Contraception/Immediate-Postpartum-LARC-Medicaid-Reimbursement?IsMobileSet=false [Accessed 12 Jan. 2019].
  • Ireland LD, Goyal V, Raker CA, Murray A, Allen RH. The effect of immediate postpartum compared to delayed postpartum and interval etonogestrel contraceptive implant insertion on removal rates for bleeding. Contraception. 2014 Sep;90(3):253-8. doi: 10.1016/j.contraception.2014.05.010. Epub 2014 May 24. PubMed 24973904 ↗
  • Phemister DA, Laurent S, Harrison FN Jr. Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. Am J Obstet Gynecol. 1995 Jan;172(1 Pt 1):175-9. doi: 10.1016/0002-9378(95)90109-4. PubMed 7847530 ↗
  • Dobromilsky KC, Allen PL, Raymond SH, Maindiratta B. A prospective cohort study of early postpartum etonogestrel implant (Implanon(R)) use and its effect on duration of lochia. J Fam Plann Reprod Health Care. 2016 Jul;42(3):187-93. doi: 10.1136/jfprhc-2014-101081. Epub 2015 Nov 6. PubMed 26545933 ↗
  • Horibe M, Hane Y, Abe J, Matsui T, Kato Y, Ueda N, Sasaoka S, Motooka Y, Hatahira H, Hasegawa S, Kinosada Y, Hara H, Nakamura M. Contraceptives as possible risk factors for postpartum depression: A retrospective study of the food and drug administration adverse event reporting system, 2004-2015. Nurs Open. 2018 Jan 17;5(2):131-138. doi: 10.1002/nop2.121. eCollection 2018 Apr. PubMed 29599988 ↗
  • Roberts TA, Hansen S. Association of Hormonal Contraception with depression in the postpartum period. Contraception. 2017 Dec;96(6):446-452. doi: 10.1016/j.contraception.2017.08.010. Epub 2017 Sep 1. PubMed 28867443 ↗
  • Flore M, Chen XL, Bonney A, Mullan J, Dijkmans-Hadley B, Hodgkins A, Evans G, Frew H, Lloyd G. Patients' perspectives about why they have their contraceptive Implanon NXT device removed early. Aust Fam Physician. 2016 Oct;45(10):740-744. PubMed 27695725 ↗
  • SAFE-T Pocket Card: Suicide Assessment Five-Step Evaluation and Triage for Clinicians. SAMHSA
  • Higgins JA, Sanders JN, Palta M, Turok DK. Women's Sexual Function, Satisfaction, and Perceptions After Starting Long-Acting Reversible Contraceptives. Obstet Gynecol. 2016 Nov;128(5):1143-1151. doi: 10.1097/AOG.0000000000001655. PubMed 27741195 ↗
  • Meston CM, Derogatis LR. Validated instruments for assessing female sexual function. J Sex Marital Ther. 2002;28 Suppl 1:155-64. doi: 10.1080/00926230252851276. PubMed 11898697 ↗
  • Sanders JN, Higgins JA, Adkins DE, Stoddard GJ, Gawron LM, Turok DK. The Impact of Sexual Satisfaction, Functioning, and Perceived Contraceptive Effects on Sex Life on IUD and Implant Continuation at 1 Year. Womens Health Issues. 2018 Sep-Oct;28(5):401-407. doi: 10.1016/j.whi.2018.06.003. Epub 2018 Aug 18. PubMed 30131221 ↗
  • Li R, Fein SB, Chen J, Grummer-Strawn LM. Why mothers stop breastfeeding: mothers' self-reported reasons for stopping during the first year. Pediatrics. 2008 Oct;122 Suppl 2:S69-76. doi: 10.1542/peds.2008-1315i. PubMed 18829834 ↗
  • Odom EC, Li R, Scanlon KS, Perrine CG, Grummer-Strawn L. Reasons for earlier than desired cessation of breastfeeding. Pediatrics. 2013 Mar;131(3):e726-32. doi: 10.1542/peds.2012-1295. Epub 2013 Feb 18. PubMed 23420922 ↗

Study documents

  • Protocol and statistical analysis plan · May 15, 2024
  • Informed consent form · Jun 1, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03978598
Lead sponsor
University of New Mexico
Collaborators
Society of Family Planning
Responsible party
Sponsor
First posted
Jun 7, 2019
Start date
Jun 3, 2019
Primary completion
Jun 4, 2024
Completion
Sep 19, 2024
Results posted
Sep 8, 2025
Last update
Nov 28, 2025

Study contacts

Jamie Krashin@salud.unm.edu
principal investigator · University of New Mexico

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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