Uptake of levonorgestrel releasing intrauterine system (LNG-IUS, Mirena 'Registered Trademark') at caesarean section

Initiating long acting reversible contraception at the time of delivery has several advantages that include high patient motivation, convenience, access to trained professionals, no need for an outpatient insertion (which may be uncomfortable) and immediate contraception prior to the resumption of ovulation(1, 2) . Levonorgestrel releasing intrauterine system (LNGIUS, Mirena, Bayer Healthcare), is an intrauterine long acting reversible contraceptive that provides contraception for 5 years(3). In Australia its use almost always involves insertion through the vagina 6 weeks or more after childbirth (standard insertion). The 2016 Australian contraception guidelines rate immediate insertion of LNGIUS at delivery including caesarean section as category 1 (that is no restrictions placed on use) (4). Mwalwanda and Black (2013) note that, “No studies have specifically examined the uptake rate, long term continuation rates, acceptability or effectiveness” (of LNG-IUS in the immediate postpartum period) (2). Intrauterine device (IUD) insertion has low rates of adverse events such as pain and infection, regardless of timing or route of insertion(1, 5). Expulsion rates following device insertion at the time of caesarean may be higher than following standard insertion but more research is required to quantify the risk. Expulsion of IUDs including LNG-IUS following standard insertion is reported to occur in approximately 1 in 20 women(2). Three studies have been examined expulsion rates of LNG-IUS inserted at caesarean section. Expulsion rates were 0%(6, 7) and 20% (8). IUDs including LNGIUS have nylon strings attached. The strings are useful because they can be seen or felt to check that the device is still present, and they can be pulled to remove the device when this is desired. When devices are inserted through the vagina into the uterus the strings are always visible in the vagina initially, and the chance of strings not being visible in the cervix at follow up visits is 5%(9). When IUDs are inserted at caesarean section the chance of the strings not being in the vagina at followup is 8%(10). Patient satisfaction with LNG-IUS insertion at caesarean section has been found to be high, and not different to standard insertion(7). Continued use of LNGIUS inserted at caesarean for 12 months after delivery has been found to be higher than following standard insertion but this difference was not statistically significant (60.0% vs 40.9%, p=0.35)(8). LNG-IUS contains the hormone levonorgestrel, which is a progestogen. Studies of use of various types of progestogen containing contraceptives early in the neonatal period have not show a consistent adverse effect on breastfeeding initiation or continuation, or on neonatal outcomes such as growth and development(11). LNGIUS insertion at the time of caesarean section is associated with reduced postpartum bleeding compared with insertion of copper-containing IUD at caesarean section or no device insertion at caesarean section(12). There is some evidence that the theoretical advantages of LNGIUS insertion at caesarean encourage higher patient uptake. Two studies of immediate LNGIUS insertion at the time of caesarean section compared to standard insertion showed that more women had the procedure done in the immediate insertion group (19/20 vs 18/22)(8) and 25/25 vs 19/23(7) . This trial aims to offer LNGIUS insertion at elective caesarean section. Uptake rate is the primary endpoint. Device expulsion, string visibility, patient satisfaction, continuing use and bleeding pattern will also be recorded. REFERENCES 1. Lopez LM. Immediate postpartum insertion of intrauterine device for contraception. Cochrane Database of Systematic Reviews [Internet]. 2015; (6). Available from: http://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,athens&db=edschh&AN=edschh.CD003036&site=eds-live. 2. Mwalwanda C, Black K. Immediate post-partum initiation of intrauterine contraception and implants: a review of the safety and guidelines for use. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2013;53(4):331-7. 3. Heinemann K, Reed S, Moehner S, Do Minh T. Original research article: Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception. 2015;91:280-3. 4. Family Planning New South Wales FPV, True Relationships and Reproductive Health. Contraception: An Australian Clinical Practice Handbook. Fourth Edition ed. Australia: Family Planning NSW,Family Planning Victoria and True Relationships and Reproductive Health; 2016. 5. Kapp N, Curtis K. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80(4):327-36. 6. Puzey M. Mirena at caesarean section. The European Journal Of Contraception & Reproductive Health Care: The Official Journal Of The European Society Of Contraception. 2005;10(3):164-7. 7. Braniff K, Gomez E, Muller R. A randomised clinical trial to assess satisfaction with the levonorgestrel- releasing intrauterine system inserted at caesarean section compared to postpartum placement. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2015;55(3):279-83. 8. 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. 9. Marchi N, Castro S, Hidalgo M, Hidalgo C, Monteiro-Dantas C, Villarroeal M, et al. Management of missing strings in users of intrauterine contraceptives. Contraception. 2012;86(4):354-8. 10. Bhutta S, Butt I, Bano K. Insertion of intrauterine contraceptive device at caesarean section. Journal Of The College Of Physicians And Surgeons Pakistan. 2011;21(9):527-30. 11. FSRH. Clinical Effectiveness Unit Guidance Intrauterine Contraception April 2015 2015 [updated October 2015]. Available from: https://www.fsrh.org/documents/ceuguidanceintrauterinecontraception/. 12. Elsedeek M. Puerperal and menstrual bleeding patterns with different types of contraceptive device fitted during elective cesarean delivery. International Journal Of Gynaecology And Obstetrics. 2012;116(1):31-4.