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Postpartum ContraceptionPhase 3LADIINCT02866643

Labor and Delivery Implant Insertion: A Randomized Controlled Trial

A Phase 3 study testing Etonogestrel-Immediate and Etonogestrel-Delayed in people with Postpartum Contraception and Family Planning, run by Stanford University at 1 site 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

A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Contraception, Family Planning
What is being tested?
Etonogestrel-Immediate and Etonogestrel-Delayed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteUnited States
Study dates
28 Oct 2016to 31 Jul 2021
Phase
Phase 3
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant women who are patients of the Stanford University Obstetrics service
  • Pregnant women who delivery a healthy infant, regardless of gestational age.
  • Intend to breastfeed
  • Desire the contraceptive implant as their method of contraception
  • Agree to be randomized to delivery room vs. postpartum ward insertion

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

  • Obstetrics--Lucile Packard Children's Hospital

    Stanford, California, 94305

Other trials in United States

About this study

A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82 consenting women will be randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room or insertion of the implant following delivery in postpartum room and prior to medical discharge (24-48 hours following delivery).

Participants complete a questionnaire that asks questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire also includes questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.

Being tested
Etonogestrel-Immediate, Etonogestrel-Delayed
Keywords
contraceptive implant, postpartum contraception, breastfeeding and contraception
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-ImmediateDrug

    Also called Nexplanon, Contraceptive Implant

    The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).

  • Etonogestrel-DelayedDrug

    Also called Nexplanon, Contraceptive Implant

    The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.

Study groups in NCT02866643
Study groupRoleWhat they receive
Delivery Room InsertionExperimentalParticipants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
Receives: Drug: Etonogestrel-Immediate
Postpartum InsertionActive comparatorParticipants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
Receives: Drug: Etonogestrel-Delayed

What is being measured

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

  1. Time to Lactogenesis Stage II [Questionnaire]

    Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception.

    To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery.

    Measured: Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.

Secondary outcomes (5)

  1. Number of of Participants Actively Breastfeeding

    Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula.

    Measured: 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery

  2. Number of Participants Still With the Contraceptive Implant at Month 12.

    Measured: month 12

  3. Number of Participants Satisfied or Very Satisfied With Implant Contraceptive

    Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied.

    Measured: month 12

  4. Number of Participants Reporting a Pregnancy Within 12 Months

    Measured: 12 months

  5. Number of Participants Attending a Postpartum Care Visit by Month 3

    Measured: month 3

Timeline

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

  1. First posted15 Aug 2016 (estimated)
  2. Study start28 Oct 2016
  3. Primary completion6 Sep 2019
  4. Study completion31 Jul 2021

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866643
Sponsor's protocol ID
IRB-38505
Acronym
LADII
Status last verified
Jun 2022
First submitted
5 Aug 2016
Last updated
25 Jul 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Finer LB, Zolna MR. Declines in Unintended Pregnancy in the United States, 2008-2011. N Engl J Med. 2016 Mar 3;374(9):843-52. doi: 10.1056/NEJMsa1506575.

    PubMed 26962904

  • Zhu BP. Effect of interpregnancy interval on birth outcomes: findings from three recent US studies. Int J Gynaecol Obstet. 2005 Apr;89 Suppl 1:S25-33. doi: 10.1016/j.ijgo.2004.08.002.

    PubMed 15820365

  • Zhu BP, Rolfs RT, Nangle BE, Horan JM. Effect of the interval between pregnancies on perinatal outcomes. N Engl J Med. 1999 Feb 25;340(8):589-94. doi: 10.1056/NEJM199902253400801.

    PubMed 10029642

  • Mayer JP. Unintended childbearing, maternal beliefs, and delay of prenatal care. Birth. 1997 Dec;24(4):247-52. doi: 10.1111/j.1523-536x.1997.tb00598.x.

    PubMed 9460316

  • Heller R, Cameron S, Briggs R, Forson N, Glasier A. Postpartum contraception: a missed opportunity to prevent unintended pregnancy and short inter-pregnancy intervals. J Fam Plann Reprod Health Care. 2016 Apr;42(2):93-8. doi: 10.1136/jfprhc-2014-101165. Epub 2015 Dec 8.

    PubMed 26645197

  • Speroff L, Mishell DR Jr. The postpartum visit: it's time for a change in order to optimally initiate contraception. Contraception. 2008 Aug;78(2):90-8. doi: 10.1016/j.contraception.2008.04.005. Epub 2008 Jun 12. No abstract available.

    PubMed 18672108

  • Centers for Disease Control and Prevention (CDC). Postpartum care visits--11 states and New York City, 2004. MMWR Morb Mortal Wkly Rep. 2007 Dec 21;56(50):1312-6.

    PubMed 18097343

  • Gariepy AM, Duffy JY, Xu X. Cost-Effectiveness of Immediate Compared With Delayed Postpartum Etonogestrel Implant Insertion. Obstet Gynecol. 2015 Jul;126(1):47-55. doi: 10.1097/AOG.0000000000000907.

    PubMed 26241255

  • Centers for Disease Control and Prevention (CDC). Contraceptive use among postpartum women - 12 states and New York City, 2004-2006. MMWR Morb Mortal Wkly Rep. 2009 Aug 7;58(30):821-6.

    PubMed 19661855

  • Centers for Disease Control and Prevention (CDC). Update to CDC's U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: revised recommendations for the use of contraceptive methods during the postpartum period. MMWR Morb Mortal Wkly Rep. 2011 Jul 8;60(26):878-83.

    PubMed 21734635

  • Medical Eligibility Criteria for Contraceptive Use. 5th edition. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321151/

    PubMed 26447268

  • Dunn K, Bayer LL, Mody SK. Postpartum contraception: An exploratory study of lactation consultants' knowledge and practices. Contraception. 2016 Jul;94(1):87-92. doi: 10.1016/j.contraception.2016.03.007. Epub 2016 Mar 17.

    PubMed 26996737

  • Duvan CI, Gozdemir E, Kaygusuz I, Kamalak Z, Turhan NO. Etonogestrel contraceptive implant (Implanon): analysis of patient compliance and adverse effects in the breastfeeding period. J Turk Ger Gynecol Assoc. 2010 Sep 1;11(3):141-4. doi: 10.5152/jtgga.2010.21. eCollection 2010.

    PubMed 24591920

  • 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

  • Taneepanichskul S, Reinprayoon D, Thaithumyanon P, Praisuwanna P, Tosukhowong P, Dieben T. Effects of the etonogestrel-releasing implant Implanon and a nonmedicated intrauterine device on the growth of breast-fed infants. Contraception. 2006 Apr;73(4):368-71. doi: 10.1016/j.contraception.2005.10.010. Epub 2005 Dec 27.

    PubMed 16531169

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etonogestrel-Immediate and Etonogestrel-Delayed in people with Postpartum Contraception and Family Planning, run by Stanford University 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 5 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 25 Jul 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Sep 2020). 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?

Time to Lactogenesis Stage II [Questionnaire] (time frame: Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.). 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 NCT02866643, which also lists 20 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 25 Jul 2022.

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