Editorial: Containing contraceptive costs

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Dimensional analysis of the endometrial cavity: how many dimensions should the ideal intrauterine device or system have?

Norman D Goldstuck Department of Obstetrics and Gynecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Bellville, Western Cape, South Africa Background: The geometrical shape of the human uterus most closely approximates that of a prolate ellipsoid. The endometrial cavity itself is more likely to also have the shape of a prolate ellipsoid especially when the extension of the cervix is omitted. Using this information and known endometrial cavity volumes and lateral and vertical dimensions, it is possible to calculate the anteroposterior (AP) dimensions and get a complete evaluation of all possible dimensions of the endometrial cavity. These are singular observations and not part of any other study.Methods: The AP dimensions of the endometrial cavity of the uterus were calculated using the formula for the volume of the prolate ellipsoid to complete a three-dimensional picture of the endometrial cavity.Results: Calculations confirm ultrasound imaging which shows large variations in cavity size and shape. Known cavity volumes and length and breadth measurements indicate that the AP diameter may vary from 6.29 to 38.2 mm. These measurements confirm the difficulty of getting a fixed-frame intrauterine device (IUD) to accommodate to a space of highly variable dimensions. This is especially true of three-dimension IUDs. A one-dimensional frameless IUD is most likely to be able to conform to this highly variable space and shape.Conclusion: The endometrial cavity may assume many varied prolate ellipsoid configurations where one or more measurements may be too small to accommodate standard IUDs. A one-dimensional device is most likely to be able to be accommodated by most uterine cavities as compared to two- and three-dimensional devices. Keywords: intrauterine device, dimensions, endometrial cavity, prolate ellipsoid, variable space and shap

Intrauterine contraception after cesarean section and during lactation: a systematic review

Norman D Goldstuck,1 Petrus S Steyn2 1Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, Western Cape, South Africa; 2Reproductive Health and Fertility Regulation, Department of Obstetrics and Gynaecology, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa Background: All postpartum women, including those who are breastfeeding or have had a cesarean section, appear potentially suited to intrauterine contraception, a long acting reversible contraceptive (LARC). Like any other method used after delivery, it should not interfere with lactation or be affected by cesarean section. Study design: We searched the MEDLINE, PubMed, Popline, Google Scholar, and Clinicaltrials.gov databases from January 1968 through to December 2012. Studies were included if they reported event rates in women who had a cesarean section and event rates and clinical outcomes in lactating women or their infants in the breastfeeding group. Summary odds ratios were not calculated because of the diverse methods of reporting event rates in the cesarean section group and the heterogeneity of the results in the breastfeeding group. Results: We found 26 articles on event rates in interval and post-placental intrauterine device (IUD) use, and 18 on event rates and clinical outcomes in breastfeeding IUD users. Four prospective studies and one retrospective study showed an increased expulsion rate in interval insertion. There were 19 studies, of which five were controlled in post-placental IUD insertion after cesarean section. Four studies had expulsion rates of 10 or more per 100 woman-years of use and 15 expulsion rates below 10 per 100 woman-years of use. Three studies showed that event rates for lactating IUD users are the same as those for non-lactating users. Fifteen controlled studies showed that the IUD had no effect on milk production and seven of these showed no effect on infant growth. Pharmacovigilance databases report an increased rate of IUD perforations in lactating women, while the event rate studies report that insertion is generally easier and less painful than expected. These were uncontrolled reports. Conclusion: The IUD is a long-acting reversible method of contraception with expulsion rates of 5–15 per 100 woman-years of use when used as a post-placental method immediately after cesarean section. As an interval procedure (6 or more weeks after cesarean section) it appears to have a high expulsion rate (5% or higher) notably in older devices. The IUD does not affect breastfeeding and is easy to insert in these women, but appears to be associated with a higher perforation rate (>1 per 100). Providers should not be deterred from using this contraception method, especially in developing countries, but should be attentive to preventing these potential problems. Keywords: long acting reversible contraception, IUD, cesarean section, post-placental, lactatio

Role of uterine forces in intrauterine device embedment, perforation, and expulsion

Norman D Goldstuck,1 Dirk Wildemeersch2 1Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Western Cape, South Africa; 2Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium Background: The purpose of this study was to examine factors that could help reduce primary perforation during insertion of a framed intrauterine device (IUD) and to determine factors that contribute in generating enough uterine muscle force to cause embedment and secondary perforation of an IUD. The objective was also to evaluate the main underlying mechanism of IUD expulsion. Methods: We compared known IUD insertion forces for “framed” devices with known perforation forces in vitro (hysterectomy specimens) and known IUD removal forces and calculated a range of possible intrauterine forces using pressure and surface area. These were compared with known perforation forces. Results: IUD insertion forces range from 1.5 N to 6.5 N. Removal forces range from 1 N to 5.8 N and fracture forces from 8.7 N to 30 N depending upon device. Measured perforation forces are from 20 N to 54 N, and calculations show the uterus is capable of generating up to 50 N of myometrial force depending on internal pressure and surface area. Conclusion: Primary perforation with conventional framed IUDs may occur if the insertion pressure exceeds the perforation resistance of the uterine fundus. This is more likely to occur if the front end of the inserter/IUD is narrow, the passage through the cervix is difficult, and the procedure is complex. IUD embedment and secondary perforation and IUD expulsion may be due to imbalance between the size of the IUD and that of the uterine cavity, causing production of asymmetrical uterine forces. The uterine muscle seems capable of generating enough force to cause an IUD to perforate the myometrium provided it is applied asymmetrically. A physical theory for IUD expulsion and secondary IUD perforation is given. Keywords: IUD, insertion forces, removal forces, fracture forces, intrauterine pressure, intrauterine surface are

Expulsion and continuation rates after postabortion insertion of framed IUDs versus frameless IUDs – review of the literature

Dirk Wildemeersch,1 Norman D Goldstuck2 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg Hospital, Western Cape, South Africa Background: Early intrauterine device (IUD) discontinuation after insertion immediately following aspiration abortion or after early medical abortion occurs as a consequence of expulsion of the IUD or removal due to side effects. These are often the consequence of the uterine forces impacting on the IUD due to spatial discrepancy with the uterine cavity causing pain, abnormal bleeding, and eventually, removal of the IUD. These women are candidates for repeat pregnancy as they often select less-effective methods or no contraception at all. Repeat abortion could be reduced by giving attention to these factors. Study design: In order to have an indication on the magnitude of the problem of IUD expulsion or discontinuation, we searched the MEDLINE database for clinical trials, randomized controlled trials, and prospective observational studies related to immediate postaspiration termination of pregnancy (TOP) and early medical abortion IUD insertion studies that reported IUD expulsion and IUD continuation rates. Results: The search identified 17 clinical trials that were suitable based on the data they presented. The majority concerned T-shape IUDs, inserted immediately following surgical (aspiration) pregnancy termination. Two studies were conducted after medical TOP, and four studies were conducted with the frameless IUD inserted after surgical (vacuum aspiration) TOP. The results showed expulsion rates between 0.8% and 17.3% at 8 weeks, up to 5 years after insertion, respectively. In four studies with the frameless IUD, totaling 553 insertions, the expulsion rate was 0.0% in three of them. Follow-up in the latter studies varied between 5 weeks and 54 months. Reported continuation rates with conventional (framed) IUDs were between 33.8% and 80% at 1 year for studies providing 1 year rates and between 68% and 94.1% for studies reporting continuation rates at 6 months. Studies utilizing frameless IUDs reported 1 year continuation rate over 95%. Conclusion: Frameless IUDs, due to their attachment to the uterine fundus, appear to be better retained by the postabortal uterus when compared with conventional framed IUDs. The absence of a frame ensures compatibility with uterine cavity anatomical dimensions, and may therefore result in improved acceptability and continuation rates in comparison with framed IUDs. Both these characteristics of the frameless IUD could help reduce the number of repeat unwanted pregnancies and subsequent abortions in some cases. Keywords: IUD, abortion, frameless IUD, expulsion, continuation, repeat abortion, unintended pregnanc

Intrauterine levonorgestrel delivery with frameless fibrous delivery system: review of clinical experience

Dirk Wildemeersch,1 Amaury Andrade,2 Norman D Goldstuck,3 Thomas Hasskamp,4 Geert Jackers5 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Centro de Biologia da Reprodução, Universidade Federal Juiz de Fora, Juiz de Fora, Brazil; 3Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Western Cape, South Africa; 4Klinik für Operativen Gynäkologie, GynMünster, Münster, Germany; 5Applied Controlled Release, Technology Park, Ghent (Zwijnaarde), Belgium Abstract: The concept of using a frameless intrauterine device (IUD) instead of the conventional plastic framed IUD is not new. Frameless copper IUDs have been available since the late 1990s. They rely on an anchoring system to retain in the uterine cavity. The clinical experience with these IUDs suggests that frameless IUDs fit better as they are thin and, therefore, do not disturb or irritate the uterus. High tolerance and continuation rates have been achieved as complaints of pain are virtually nonexistent and the impact on menstrual blood loss is minimal. Conventional levonorgestrel-releasing intrauterine systems (LNG-IUSs) are very popular as they significantly reduce menstrual bleeding and provide highly effective contraception. However, continuation of use remains problematic, particularly in young users. Total or partial expulsion and displacement of the LNG-IUS also occur too often due to spatial incompatibility within a small uterine cavity, as strong uterine contractions originate, attempting to get rid of the bothersome IUD/IUS. If not expelled, embedment ensues, often leading to chronic pain and early removal of the IUD/IUS. Several studies conducted recently have requested attention to the relationship between the LNG-IUS and the endometrial cavity. Some authors have proposed to measure the cavity width prior to inserting an IUD, as many uterine cavities are much smaller than the currently existing LNG-IUSs. A frameless fibrous drug delivery system fits, in principle, in all uterine cavities and may therefore be preferable to framed drug delivery systems. This review examines the clinical performance, acceptability, and potential of the frameless LNG-IUS (FibroPlant®) when used for contraception, treatment of heavy menstrual bleeding, dysmenorrhea, and endometrial suppression in women using estrogen replacement therapy, endometrial hyperplasia, and other gynecological conditions. The review concludes that FibroPlant LNG-IUS offers unique advantages in reducing side effects. Keywords: LNG-IUS, frameless, efficacy, safety, acceptabilit