Abstract
Objective:
To determine the association between provider training level and postplacental intrauterine device (IUD) outcomes following insertion instruction by email only.
Study Design:
We conducted a single-center chart review of demographics, insertion, and clinical outcomes within six months of delivery for 116 patients who underwent postplacental levonorgestrel 52 mg IUD placement from October 1, 2016 to March 31, 2017.
Results:
We confirmed IUD retention, removal, or expulsion in 87 of 116 (75.0%) patients by six months after delivery. Complete expulsion or removal for malposition occurred in 20 (23.0%) patients and more frequently after vaginal than cesarean delivery (30.2% vs. 4.2%, OR 9.93 [95% CI 1.25–78.96]) and when a Postgraduate Year (PGY) 1 physician placed the IUD compared to a PGY 2–4 or attending physician (37.5% vs. 14.5%, OR 3.52 [95% CI 1.25–9.94)).
Conclusion:
Postplacental levonorgestrel 52 mg IUD expulsion rates are associated with provider training level as well as delivery route, though the individual association of each of these factors is difficult to ascertain given the high degree of collinearity between these two variables in our study.
Keywords: postplacental intrauterine device, postpartum contraception, residency training, IUD expulsion, delivery route
1.0. Introduction
Intrauterine device (IUD) insertion immediately postpartum is safe, convenient, desired by patients, and expands access to long-acting reversible contraception (LARC) [1]. However, the impact of provider training level on postplacental IUD outcomes is not clearly known [2,3]. Jatlaoui et al [2] found no difference in expulsion rates when comparing insertion by lower (postgraduate [PGY] 1/2) and senior level (PGY 3/4) residents, though the study was underpowered to detect a meaningful difference. Furthermore, postplacental IUD expulsion specifically following placement by PGY 1 physicians, who perform the majority of vaginal deliveries in many training programs and may have less experience in similar clinical skills such as manual removal of the placenta or uterine bimanual massage for hemorrhage, has not been previously reported. Therefore, we conducted a retrospective analysis of a PPIUD initiative at our academic county hospital to explore the clinical and demographic factors associated with PPIUD expulsion, including provider training level completing the placement. We anticipated a higher risk of expulsion for those providers with less training.
2.0. Material and Methods
We performed a retrospective cohort analysis of data collected within a prospective PPIUD initiative conducted at an academic county hospital in Cleveland, Ohio, for deliveries between October 1, 2016 to March 31, 2017. The MetroHealth Medical Center institutional review board approved the study. We introduced the PPIUD initiative via an email to residents and faculty describing inclusion and exclusion criteria, counseling, insertion techniques, and follow-up for PPIUD placement (Appendix 1) [4]. One author (KSA) had experience with PPIUD placement during residency training; no other providers had past training or experience. In patients who desired and consented to placement, the resident physician completing the delivery (with direct attending physician supervision) or the attending physician (if no trainee was available for delivery) inserted the IUD within 10 minutes of placental delivery. We exclusively used a single IUD, the levonorgestrel 52 mg IUD (Liletta®, Medicines360, San Francisco, CA), to eliminate potential outcome differences based on IUD type and due to lower cost.
We reviewed billing reports for all women who had a delivery during the study time frame to identify patients who had a PPIUD placement and confirmed IUD distribution with pharmacy logs. We reviewed delivery records and clinical course from the electronic medical record through six months after delivery. We abstracted demographic data; training status of the provider who inserted the PPIUD; and outcomes including expulsion or removal within six months, need for additional imaging to locate the IUD, and reason for IUD removal. We defined expulsion by either (a) patient report of expulsion as recorded in the electronic medical record or (b) confirmatory imaging with ultrasound or x-ray if the clinician noted no threads at a postpartum examination. We did not explicitly define malposition for study purposes and abstracted the reason for removal based on documentation.
We present results for only women who had confirmation of either retention, removal, or expulsion of the levonorgestrel 52 mg IUD within 6 months of delivery. We compared rates of expulsion and removal for malposition according to clinical and demographic characteristics by Chi-square or Wilcoxon rank sum test, as appropriate, as well as odds ratios with use of the Haldane-Anscombe correction when necessary. We calculated variance inflation factors (VIFs) of all significant associations with expulsion to assess collinearity. All analyses were two-tailed. We used R software (version 3.4.0) for data analysis [5] and considered a p-value < 0.05 as statistically significant.
3.0. Results
During the six-month study timeframe, 1,506 deliveries occurred with 116 (7.7%) having a PPIUD insertion (Table 1). Physicians placed the IUD either manually (n=101, 87.1%), with a ring forceps (n=8, 6.9%), or with the inserter (n=6, 5.2%); only two (1.7%) procedures included ultrasound guidance.
Table 1.
Demographic characteristics of all women undergoing postplacental levonorgestrel 52 mg intrauterine device placement and of those with confirmation of IUD retention, removal, or expulsion at 6 months post-delivery.
| All placements n=116 | Placements with Confirmation n=87 | p-value | |
|---|---|---|---|
| Age (years) | 26 (22–30) | 27 (23–30) | 0.46 |
| Parity | 2 (1–3) | 2 (1–3) | 0.52 |
| BMI (kg/m2) | 32 (27–38) | 32 (27–39) | 0.46 |
| Race | 0.85 | ||
| Asian | 1 (0.9) | 1 (1.1) | |
| Black | 50 (43.1) | 37 (42.5) | |
| Hispanic | 15 (12.9) | 15 (17.2) | |
| White | 47 (40.5) | 32 (36.8) | |
| Other/Unknown | 3 (2.6) | 1 (1.1) | |
| Insurance | 0.65 | ||
| Medicaid | 99 (85.3) | 70 (80.5) | |
| Private | 12 (10.3) | 12 (13.8) | |
| None | 5 (4.3) | 5 (5.7) | |
| Education Level | 0.92 | ||
| Grade 12 or less without graduating | 40 (34.5) | 25 (28.7) | |
| High school diploma or GED | 38 (32.8) | 29 (33.3) | |
| Some college | 22 (19.0) | 18 (20.7) | |
| Bachelors degree | 8 (6.9) | 7 (8.0) | |
| Graduate degree | 5 (4.3) | 5 (5.7) | |
| Unknown | 3 (2.6) | 1 (1.1) | |
| Married | 0.53 | ||
| Yes | 18 (15.5) | 17 (19.5) | |
| No | 97 (83.6) | 70 (80.5) | |
| Unknown | 1 (0.9) | 0 (0) | |
| Gestational age at delivery (weeks) | 39 (37–39) | 39 (37–39) | 0.88 |
| Delivery route | 0.89 | ||
| Vaginal | 83 (71.6) | 63 (72.4) | |
| Cesarean | 33 (28.4) | 24 (27.6) | |
| Provider training level | 0.96 | ||
| PGY 1 | 42 (36.2) | 32 (36.8) | |
| PGY 2–4 | 62 (53.4) | 32 (36.8) | |
| Attending | 12 (10.3) | 8 (9.2) |
Data presented as n (%) or median (interquartile range)
BMI = body-mass index
PGY = Postgraduate year
Within six months of delivery, 87 (75.0%) patients had a documented follow-up assessment with outcomes of retention, removal, or expulsion reported in Table 2. Twenty (23.0%) patients had complete expulsion or IUD removal for malposition. Thirteen (76.5%) expulsions occurred within the first 30 days.
Table 2.
Outcomes for women with confirmation of either levonorgestrel 52 mg IUD retention, removal, or expulsion.
| Placements with confirmation n=87 | |
|---|---|
| Postpartum infection | 4 (4.6) |
| IUD removed | 6 (6.9) |
| Indication for IUD removal | |
| Malposition without pain | 2 (2.3) |
| Malposition with pain | 1 (1.1) |
| Pain only | 2 (2.3) |
| Bleeding | 1 (1.1) |
| Breastmilk supply concern | 1 (1.1) |
| Postpartum visit within 90 days of discharge | 83 (95.4) |
| Expulsion within six months of discharge† | 17 (19.5) |
| Postpartum IUD threads not visible on exam | 24‡ (27.6) |
| Ultrasound Examination Ordered | 13 (14.9) |
| Examination completed | 11 (12.6) |
Data presented as n (%)
IUD=intrauterine device
Expulsion defined as either (a) patient report of expulsion as recorded in the electronic medical record or (b) confirmatory imaging with ultrasound or x-ray if no threads were noted at the time of postpartum examination
14 had expulsions by patient report or ultrasound examination
Factors associated with expulsion and removal for malposition are reported in Table 3. Inserter training level was associated with expulsion or removal for malposition across all levels of training (p = 0.002). Regression modeling of the two significant factors (delivery route and provider training level) demonstrated a high degree of collinearity (VIF 15.0 for delivery route and 9.5 for training level) and therefore, multivariable regression was not performed. In the subgroup of those patients with vaginal deliveries, the association between training level and expulsion or removal for malposition was no longer significant (36.7% expulsion when placed by an PGY 1 physician vs. 24.2% expulsion when placed by a PGY 2–4 or attending physician, p=0.42).
Table 3.
Factors associated with postplacental levonorgestrel 52 mg intrauterine device (IUD) outcome
| n | Confirmed IUD Expulsion/Removal for Malposition n=20 | OR (95% CI) | |
|---|---|---|---|
| Parity | 0.36 (0.09–1.36) | ||
| Primiparous | 25 | 3 (12.0) | |
| Multiparous | 62 | 17 (27.4) | |
| Delivery route | 9.93 (1.25–78.96) | ||
| Vaginal | 63 | 19 (30.2) | |
| Cesarean* | 24 | 1 (4.2) | |
| Gestational age at delivery | 12.10 (0.69211.80) | ||
| Preterm (<37 weeks) | 15 | 0 | |
| Term (≥37 weeks) | 72 | 20 (27.8) | |
| BMI (kg/m2) | 3.66 (1.11–12.09) | ||
| < 30 | 36 | 4 (11.1) | |
| ≥ 30 | 51 | 16 (31.4) | |
| Provider training level | 3.52 (1.25–9.94) | ||
| Attending or PGY 2–4 | 55 | 8 (14.5) | |
| PGY 1 | 32 | 12 (37.5) | |
| Placement method | -- | ||
| Manual | 78 | 17 (21.8) | |
| Inserter | 3 | 0 | |
| Ring | 5 | 2 (40.0) | |
| Unknown | 1 | 1 (100.0) | |
| Infection | 4 | 0 | 0.34 (0.02–6.67) |
| Ultrasound used at time of placement | 2 | 1 (50.0) | 3.47 (0.21–58.18) |
| Data presented as n (%) |
BMI = body-mass index
PGY = Postgraduate year
OR = Odds ratio
CI = Confidence interval
All scheduled cesarean deliveries except one woman in the XX group in active labor
4.0. Discussion
We found a combined complete expulsion and removal for malposition rate of 23.0% after initiation of a postplacental levonorgestrel 52 mg IUD placement program at our urban teaching hospital. This rate is similar to or lower than that reported in previously published prospective studies [6–10]. The two risk factors associated with expulsion or removal for malposition identified in our study were vaginal delivery and placement by a PGY 1 physician despite direct attending physician supervision during PPIUD insertion. Possible explanations for the former include lack of advanced cervical dilation for scheduled cesarean deliveries, ease of placing the IUD correctly at the uterine fundus due to ability to palpate the fundus directly, and excellent anesthesia at time of cesarean delivery. In contrast to our findings, one contemporary study has shown no significant difference in expulsion rate between vaginal and cesarean deliveries [10], whereas a different study had similar findings to ours [11]. A systematic review also concluded that expulsion was more common after vaginal rather than cesarean delivery, but included both immediate (within 10 minutes of placental delivery) and early (greater than 10 minutes to less than 4 weeks) in the comparison [12]. However, given the small number of cesareans performed in active labor, we are unable to draw conclusions for laboring women undergoing cesarean delivery.
Previous studies have evaluated the correlation between provider training level and IUD expulsion though have been underpowered to detect a difference or have not studied the resident trainee population specifically [2,3]. The higher expulsion rate of IUDs placed by PGY 1 physicians after email-only instruction suggests that a formal education program with simulation training (as recommended by the American College of Obstetricians and Gynecologists [13]) targeted to those with less clinical experience in similar intrauterine manipulation might improve expulsion rates for these providers. Importantly, however, there was a high degree of collinearity between the two significantly associated factors of delivery route and provider training level. Furthermore, the association between provider training level and expulsion was not significant in the subgroup of vaginal deliveries, though this study was underpowered to detect a difference for this comparison. Thus, further study is necessary to analyze the relationship between these two factors and PPIUD expulsion.
Our study has limitations including ability to confirm retention or expulsion in only 75% of our cohort, reliance on email-only instruction, and lack of standardized definition or management plan for malposition. As a single IUD was used in the study, our findings may not be generalizable to other IUDs. Moving forward, further analysis of whether expulsion rate varies by provider training level after traditional simulation-based insertion education is warranted.
Supplementary Material
Acknowledgements
The authors wish to thank Lydia Bert, RNC, BSN, MBA, FACHE for her assistance in the implementation of the postplacental IUD initiative.
Funding Disclosure - Dr. Arora is funded by the Clinical and Translational Science Collaborative of Cleveland, KL2TR0002547 from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health and NIH roadmap for Medical Research. This manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Footnotes
The authors report no conflicts of interest.
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
References
- [1].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;42(2):93–8. [DOI] [PubMed] [Google Scholar]
- [2].Jatlaoui TC, Marcus M, Jamieson DJ, Goedken P, Cwiak C. Postplacental intrauterine device insertion at a teaching hospital. Contraception 2014;89(6):528–33. [DOI] [PubMed] [Google Scholar]
- [3].Morrison C, Waszak C, Katz K, Diabaté F, Mate EM. Clinical outcomes of two early postpartum IUD insertion programs in Africa. Contraception 1996;53(1):17–21. [DOI] [PubMed] [Google Scholar]
- [4].U S. medical eligibility criteria for contraceptive use, 2010. Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep 2010;59(RR-4):1–86. [PubMed] [Google Scholar]
- [5].R Core Team (2017). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria: URL https://www.R-project.org/. [Google Scholar]
- [6].Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception 2014;89(6):534–9. [DOI] [PubMed] [Google Scholar]
- [7].Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or Delayed Insertion of the Levonorgestrel Intrauterine Device After Vaginal Delivery: A Randomized Controlled Trial. Obstetrics and Gynecology 2010;116(5):1079–1087. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [8].Levi E, Cantillo E, Ades V, Banks E, Murthy A. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Contraception 2012;86(2):102–5. [DOI] [PubMed] [Google Scholar]
- [9].Eggebroten JL, Sanders JN, Turok DK. Immediate postpartum intrauterine device and implant program outcomes: a prospective analysis. Am J Obstet Gynecol 2017;217(1):51.e1–51.e7. [DOI] [PubMed] [Google Scholar]
- [10].Sucak A, Ozcan S, Çelen Ş, Çağlar T, Göksu G, Danιşman N. Immediate postplacental insertion of a copper intrauterine device: a pilot study to evaluate expulsion rate by mode of delivery. BMC Pregnancy Childbirth 2015;15:202. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [11].Colwill AC, Schreiber CA, Sammel MD, Sonalkar S. Six-week retention after postplacental copper intrauterine device placement. Contraception 2018;97(3):215–8. [DOI] [PubMed] [Google Scholar]
- [12].Jatlauoi T, Whiteman M, Jeng G, Tepper N, Berry-Bibee E, Jamieson D, et al. Intrauterine device expulsion after postpartum placement – A systematic review and meta-analysis. Obstet Gynecol 2018;132(4):895–905. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [13].Immediate postpartum long-acting reversible contraception. Committee Opinion No. 670. American College of Obstetricians and Gynecologists. Obstet Gynecol 2016;128:e32–7. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.