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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delivery Room Insertion | Experimental | Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery). |
|
| Postpartum Insertion | Active Comparator | Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel-Immediate | Drug | The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery |
| Number of Participants Still With the Contraceptive Implant at Month 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate A Shaw, MD, MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics--Lucile Packard Children's Hospital | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26962904 | Background | 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. | |
| 15820365 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Delivery Room Insertion | Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery). Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery). |
| FG001 | Postpartum Insertion | Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery). Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Per Protocol Population (received implant at protocol-specified time point)
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| ID | Title | Description |
|---|---|---|
| BG000 | Delivery Room Insertion | Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery). Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol Population (received implant at protocol-specified time point) | Posted | Mean | Standard Deviation | hours | 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. |
|
Time of enrollment through the discharge from the hospital (up to 10 days post-delivery).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delivery Room Insertion | Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery). Etonogestrel-Immediate: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Stanford University | 6507247826 | gynresearch@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2016 | Sep 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C044815 | etonogestrel |
| D003270 | Contraceptive Agents |
| ID | Term |
|---|---|
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Etonogestrel-Delayed | Drug | The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery. |
|
|
| month 12 |
| Number of Participants Satisfied or Very Satisfied With Implant Contraceptive | Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied. | month 12 |
| Number of Participants Reporting a Pregnancy Within 12 Months | 12 months |
| Number of Participants Attending a Postpartum Care Visit by Month 3 | month 3 |
| 10029642 | Background | 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. |
| 9460316 | Background | 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. |
| 26645197 | Background | 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. |
| 18672108 | Background | 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. |
| 18097343 | Background | 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. |
| 26241255 | Background | 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. |
| 19661855 | Background | 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. |
| 21734635 | Background | 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. |
| 26447268 | Background | Medical Eligibility Criteria for Contraceptive Use. 5th edition. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321151/ |
| 26996737 | Background | 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. |
| 24591920 | Background | 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. |
| 21508750 | Background | 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. |
| 16531169 | Background | 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. |
| 19913145 | Background | Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10. |
| 26209863 | Background | Braga GC, Ferriolli E, Quintana SM, Ferriani RA, Pfrimer K, Vieira CS. Immediate postpartum initiation of etonogestrel-releasing implant: A randomized controlled trial on breastfeeding impact. Contraception. 2015 Dec;92(6):536-42. doi: 10.1016/j.contraception.2015.07.009. Epub 2015 Jul 23. |
| 11110856 | Background | 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. |
| 12743453 | Background | Sievers E, Haase S, Oldigs HD, Schaub J. The impact of peripartum factors on the onset and duration of lactation. Biol Neonate. 2003;83(4):246-52. doi: 10.1159/000069485. |
| 11694638 | Background | Dewey KG. Maternal and fetal stress are associated with impaired lactogenesis in humans. J Nutr. 2001 Nov;131(11):3012S-5S. doi: 10.1093/jn/131.11.3012S. |
| BG001 |
| Postpartum Insertion |
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery). Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Gestational age at delivery (weeks), median (range) | Median | Full Range | weeks |
|
| OG001 | Postpartum Insertion | Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery). Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery. |
|
|
| Secondary | 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. | Participants with available data for the respective time points are included in the analysis | Posted | Count of Participants | Participants | 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery |
|
|
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| Secondary | Number of Participants Still With the Contraceptive Implant at Month 12. | Participants with available data are included in the analysis. | Posted | Count of Participants | Participants | month 12 |
|
|
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| Secondary | Number of Participants Satisfied or Very Satisfied With Implant Contraceptive | Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied. | Participants with available data are included in the analyses | Posted | Count of Participants | Participants | month 12 |
|
|
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| Secondary | Number of Participants Reporting a Pregnancy Within 12 Months | Posted | Count of Participants | Participants | 12 months |
|
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|
| Secondary | Number of Participants Attending a Postpartum Care Visit by Month 3 | Participants with available data are included in the analysis | Posted | Count of Participants | Participants | month 3 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Postpartum Insertion | Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery). Etonogestrel-Delayed: The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D045506 | Therapeutic Uses |
| Exclusive - week 4 |
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| Exclusive - month 3 |
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| Exclusive - month 6 |
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| Any - week 2 |
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| Any - week 4 |
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| Any - month 3 |
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| Any - month 6 |
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| Any - month 12 |
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