Postplacental placement of intrauterine devices: A randomized clinical trial

ObjectiveTo compare the expulsion rate of the TCu380A intrauterine device (IUD) or levonorgestrel (LNG) 52 mg intrauterine system (IUS) up to 90 days after postplacental placement (10 min after delivery of the placenta).Study designRandomized trial (1:1) of women aged 18–43 years and ≥37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil. Follow-up was scheduled at 42 and 90 days after device placement. We confirmed the IUD or IUS location using ultrasonography. Multivariate logistic regression was used to assess variables associated with expulsion.ResultsWe enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups. By the 90-day follow-up visit, 22/60 women (36.7%) in the TCu380A IUD group had expelled the device, as had 12/60 women in the IUS group (20%). Thirty-three of the 34 expulsions had occurred by the 42-day visit. Multivariate analysis demonstrated that the expulsion odds ratio ([OR]; 95% confidence interval [CI]) was higher after vaginal delivery than after Cesarean delivery (OR 5.60; 95% CI 2.08–15.10; P < 0.00) and higher among women with one (OR 4.38; 95% CI 1.33–14.43; P 0.00) or three or more deliveries (including the present one) (OR 6.08; 95% CI 1.78–20.77; P 0.00) than those with two deliveries.ConclusionsPostplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery. Most of the expulsions occurred within 42 days.ImplicationsPolicy makers should increase the availability of both the TCu380A and the LNG intrauterine devices for the immediate postpartum period, even though the expulsion rate is higher than that after interval placement.     

Society of Family Planning Guidelines: Postplacental insertion of intrauterine devices

Postplacental intrauterine device (IUD) placement, defined as IUD placement within 10 min after delivery of the placenta, is an appealing strategy for increasing access to postpartum IUDs because it does not require a separate postpartum visit. These guidelines present an evidence-based assessment of postplacental IUD placement after vaginal and cesarean delivery. Postplacental IUD insertion is safe and does not have higher risks of complications than interval insertion. Most studies find that the risk of IUD expulsion is higher after postplacental insertion than after interval insertion for both vaginal and cesarean deliveries. Most studies find higher rates of expulsion after vaginal delivery than after cesarean delivery. However, expulsion rates vary widely across studies, without clear evidence about the factors that may influence expulsion. In settings where replacement of expelled IUDs is available, patient populations with low rates of return for the postpartum visit are most likely to benefit from provision of postplacental IUD placement with appropriate counseling about risks and benefits.     

Administration of the etonogestrel contraceptive implant on the day of mifepristone for medical abortion: a pilot study

Objective

We sought to determine satisfaction and continuation rates of the contraceptive implant when placed on the initial visit for first-trimester medical abortion.

Study Design

In this pilot study, we placed the implant within 15 min of mifepristone administration. We assessed satisfaction with implant placement timing, 1-year implant continuation and abortion completion.

Results

We enrolled 20 participants. Sixteen (80%) returned for follow-up, and all had complete abortion. At 1 year, of 16 participants contacted, 14 (87.5%) were satisfied with implant insertion timing, and 14 (87.5%) continued the implant.

Conclusions

Initiation of the contraceptive implant on the initial visit for medical abortion resulted in high satisfaction and continuation rates.

Implications

This pilot study provides important groundwork for future larger studies to assess initiation of the contraceptive implant on the day of mifepristone for medical abortion.     

A comparative randomized study of three different IUDs in nulliparous Mexican women

With the aim to evaluate the clinical performance of intrauterine devices (IUDs) especially designed for nulliparous women (TCu 380 Nul and ML Cu 375 sl), a prospective randomized, single-blind study comparing them with standard TCu 380 A, was carried out. We included 1170 healthy nulliparous women randomly allocated to receive any of the three types of IUDs and conducted follow-up for 1 year of use. Continuation and termination rates were evaluated by gross cumulative life table analysis and compared by the log-rank test. Continuation rates (95% confidence interval) at the end of the study for TCu 380 A, TCu 380 Nul and ML Cu 375 sl were 29.5% (+/-12.9), 85.9% (+/-5.3) and 85.4% (+/-5.8), respectively (p < 0.001). There were six pregnancies during the first 3 months of use, for a failure rate of 1% (+/-0.6) in the TCu 380 A group, 0.5% (+/-0.3) in TCu 380 Nul, and no pregnancy in ML Cu 375 sl (p < 0.05). Especially designed IUDs for nulliparous women had a better clinical profile compared with the standard IUD. This may improve the use of IUD in this population.     

Acceptability of the long-term contraceptive levonorgestrel-releasing intrauterine system (Mirena): a 3-year follow-up study

This study investigated the long-term acceptability of a levonorgestrel-releasing intrauterine system (LNG-IUS) in 165 women after 6 and 36 months of use. Changes in menstrual bleeding pattern were experienced by 161 (98%) women, with a cessation or transient absence of menstruation occurring in 75 (47%) and 14 (9%) women, respectively. Amenorrhea was considered by most women (81%) as a positive change. The proportion of women with menstrual pain was reduced from 60% before use to 29% after 36 months of use with the LNG-IUS. Fear of an unwanted pregnancy became less widespread with duration of use and the device had no disturbing effects on the women or their partners during sexual intercourse. The number of women expressing that they were very satisfied with the LNG-IUS was 69% and 77% after six months and 36 months of use, respectively. LNG-IUS is a well-accepted contraceptive method, without negative influences on the sexual relationship between users and their partners, and is suitable for women requiring long-term reversible contraceptive protection.     

Weight change at 12 months in users of three progestin-only contraceptive methods

Background

Concerns about weight gain may influence contraceptive use. We compared the change in body weight over the first 12 months of use between women using the etonogestrel (ENG) implant, the levonorgestrel intrauterine system (LNG-IUS) or depot medroxyprogesterone acetate (DMPA) with women using the copper intrauterine device (IUD).

Study Design

This was a substudy of the Contraceptive CHOICE Project, a prospective cohort study of 9256 women provided no-cost contraception. Women who had been using the ENG implant, LNG-IUS, DMPA or copper IUD continuously for at least 11 months were eligible for participation. We obtained body weight at enrollment and at 12 months and compared the weight change for each progestin-only method to the copper IUD.

Results

We enrolled a total of 427 women: 130 ENG implant users, 130 LNG-IUS users, 67 DMPA users and 100 copper IUD users. The mean weight change (in kilograms) over 12 months was 2.1 for ENG implant users [standard deviation (SD)=6.7]; 1.0 for LNG-IUS users (SD=5.3); 2.2 for DMPA users (SD=4.9) and 0.2 for copper IUD users (SD=5.1). The range of weight change was broad across all contraceptive methods. In the unadjusted linear regression model, ENG implant and DMPA use were associated with weight gain compared to the copper IUD. However, in the adjusted model, no difference in weight gain with the ENG implant, LNG-IUS or DMPA was observed. Only Black race was associated with significant weight gain (1.3 kg, 95% confidence interval=0.2–2.4) when compared to other racial groups.

Conclusions

Weight change was variable among women using progestin-only contraceptives. Black race was a significant predictor of weight gain among contraceptive users.     

Cost-benefit analysis of state- and hospital-funded postpartum intrauterine contraception at a university hospital for recent immigrants to the United States

Objective

To examine the hospital and state costs of offering the option of a postpartum intrauterine device (IUD) to an underinsured population of recent immigrants to the United States with Emergency Medicaid (EM) insurance coverage only.

Study Design

This study is a retrospective cohort study comparing the costs of offering a reversible long-acting method of contraception (IUD) postpartum to women with EM and the current policy of covering the obstetrical delivery only. A cost-benefit analysis from the perspective of both the hospital and the state was conducted. A database of EM obstetrical patients from 2002 to 2006 was created from hospital billing records to calculate mean pregnancy costs and revenue, as well as the probability of repeat pregnancy and pregnancy outcome. Probability of IUD uptake and continuation was obtained from hospital records and the literature.

Results

A postpartum IUD program is not cost beneficial from the hospital's perspective, losing 70 cents per dollar spent on the program. However, the state government would save $2.94 for every dollar spent on a state-financed IUD program.

Conclusion

Considering only the direct costs associated with a repeat pregnancy, a program offering the option of postpartum IUD placement to underinsured women would significantly reduce state expenditures on subsequent pregnancies.     

Contraception and treatment in the perimenopause with a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: an extended pilot study

The objective of the study was to evaluate the contraceptive performance, acceptability, side effects, and adverse events of a novel "frameless" intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG) releasing 14 microg of LNG/day, in perimenopausal women. An ancillary objective was to evaluate the effect of the new IUS on menstrual blood loss in women with or without fibroids.The study, consisting of 109 women, suggests that FibroPlant-LNG IUS is an effective contraceptive. No pregnancies occurred with the FibroPlant-LNG IUS. The total use-related discontinuation rate at 1 year is low (1.9) and results in a high rate of continuation of use (98.1). In addition, the FibroPlant-LNG IUS demonstrated a high level of effectiveness in reducing bleeding in women with excessive menstrual flow even when medium or large fibroids were present. However, an effect on the size of the fibroids could not be demonstrated.Patient satisfaction with the method is high, which is a prerequisite for continuance of the method, and may be linked with the advantageous design characteristics of the FibroPlant-LNG IUS, the virtual absence of hormonal side effects, and the low incidence of irregular bleeding and spotting even during the first 3 months after insertion of the FibroPlant IUS. Counseling remains important though to explain to women about the possible occurrence of changes in their menstrual pattern that may sometimes be annoying but harmless.It is concluded that many women over age 40 years could substantially benefit from the advantages of this intrauterine drug delivery technology which provides contraception and treatment of a possible associated condition such as menorrhagia. The treatment also creates the opportunity to pass through the transitional perimenopausal period smoothly and to benefit fully from the advantages hormone replacement therapy offers in terms of treatment of short-term symptoms and long-term prevention by gradually replacing the waning estrogens.     

Cost-effectiveness analysis of levonorgestrel-releasing intrauterine system (LNG-IUS) 13.5 mg in contraception

Background

Levonorgestrel-releasing intrauterine system (LNG-IUS) 13.5 mg (total content) is a low-dose levonorgestrel intrauterine system for up to 3 years of use. This analysis evaluated the cost-effectiveness of LNG-IUS 13.5 mg in comparison with short-acting reversible contraceptive (SARC) methods in a cohort of young women in the United States from a third-party payer's perspective.

Study design

A state transition model consisting of three mutually exclusive health states — initial method, unintended pregnancy (UP) and subsequent method — was developed. Cost-effectiveness of LNG-IUS 13.5 mg was assessed vs. SARC methods in a cohort of 1000 women aged 20–29 years. SARC methods comprise oral contraceptives (OC), ring, patch and injections, which are the methods commonly used by this cohort. Failure and discontinuation probabilities were based on published literature, contraceptive uptake was determined by the most recent data from the National Survey of Family Growth, and costs were taken from standard US databases. One-way sensitivity analysis was conducted around key inputs, while scenario analysis assessed a comparison between LNG-IUS 13.5 mg and the existing IUS, LNG-IUS 20 mcg/24 h. The key model output was cost per UP avoided.

Results

Compared to SARC methods, initiating contraception with LNG-IUS 13.5 mg resulted in fewer UP (64 UP vs. 276 UP) and lower total costs ($1,283,479 USD vs. $1,862,633 USD, a 31% saving) over the 3-year time horizon. Results were most sensitive to the probability of failure on OC, the probability of LNG-IUS 13.5 mg discontinuation and the cost of live births. Scenario analysis suggests that further cost savings may be generated with the initiation of LNG-IUS 20 mcg/24 h in place of SARC methods.

Conclusions

From a third-party payer perspective, LNG-IUS 13.5 mg is a more cost-effective contraceptive option than SARC. Therefore, women switching from current SARC use to LNG-IUS 13.5 mg are likely to generate cost savings to third-party health care payers, driven principally by decreased UP-related expenditures and long-term savings in contraceptive costs.     

Extended use of the intrauterine device: a literature review and recommendations for clinical practice

There are multiple advantages to “extended use” of the intrauterine device (IUD) use beyond the manufacturer-approved time period, including prolongation of contraceptive and non-contraceptive benefits. We performed a literature review of studies that have reported pregnancy outcomes associated with extended use of IUDs, including copper IUDs and the levonorgestrel intrauterine system (LNG-IUS). Among parous women who are at least 25 years old at the time of IUD insertion, there is good evidence to support extended use of the following devices: the TCu380A and the TCu220 for 12 years, the Multiload Cu-375 for 10 years, the frameless GyneFix® (330 mm²) for 9 years, the levonorgestrel intrauterine system 52 mg (Mirena®) for 7 years and the Multiload Cu-250 for 4 years. Women who are at least 35 years old at the time of insertion of a TCu380A IUD can continue use until menopause with a negligible risk of pregnancy. We found no data to support use of the LNG-IUS 13.5 mg (Skyla®) beyond 3 years. When counseling about extended IUD use, clinicians should consider patient characteristics and preferences, as well as country- and community-specific factors. Future research is necessary to determine the risk of pregnancy associated with extended use of the copper IUD and the LNG-IUS among nulliparous women and women less than 25 years old at the time of IUD insertion. More data are needed on the potential effect of overweight and obesity on the long-term efficacy of the LNG-IUS.     

A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study

Background

The study was conducted to test the feasibility of conducting a randomized controlled contraceptive trial in postpartum teens and to assess whether postpartum advanced supply of emergency contraception (EC) to teenaged mothers helps to prevent repeat pregnancies of close proximity.

Study Design

We performed a randomized controlled trial of 50 postpartum teens at an urban academic medical center. Participants in the intervention arm received routine postpartum contraceptive care and advanced supply of one pack of EC pills with unlimited supply thereafter upon request. The routine care arm (RCA) received routine postpartum contraceptive care. We asked open-ended questions about how we might maximize study retention and implemented the participants' requests in both arms.

Results

Our retention rate was 78%. There were three (13%) pregnancies out of 23 participants in the intervention arm and eight (30%) pregnancies out of 27 participants in the RCA. The risk of pregnancy occurring in the intervention arm was 0.57 times that of the RCA (95% CI 0.20-1.60; p=.23).

Conclusions

A randomized controlled trial of postpartum teens to receive and not to receive advanced supply of EC is both feasible and necessary. Our study provides preliminary data to suggest that advanced supply of EC may help decrease repeat teen pregnancies.     

Ulipristal acetate prevents ovulation more effectively than levonorgestrel: analysis of pooled data from three randomized trials of emergency contraception regimens

Background

The days just prior to ovulation are the most crucial for emergency contraception (EC) efficacy. Ulipristal acetate (UPA) and levonorgestrel's (LNG) capacity to inhibit follicular rupture have never been compared directly at this time of the cycle.

Study Design

Raw data from three pharmacodynamics studies with similar methodology were pooled to allow direct comparison of UPA, LNG and LNG+meloxicam's ability to prevent ovulation when administered orally in the advanced follicular phase, with a leading follicle of ≥18 mm.

Results

Forty eight LNG-treated (1.5 mg) cycles, 31 LNG (1.5 mg) + meloxicam (15 mg), 34 UPA (30 mg) cycles and 50 placebo cycles were compared. Follicle rupture was delayed for at least 5 days in 14.6%, 38.7%, 58.8% and 4% of the LNG-, LNG+meloxicam-, UPA- and placebo-treated cycles, respectively. UPA was more effective than LNG and placebo in inhibiting follicular rupture (p=.0001), while LNG, when administered at this time of the cycle, was not different than placebo. The addition of meloxicam improved the efficacy of LNG in preventing follicular rupture (p=.0292 vs. LNG; p=.0001 vs. placebo; non-significant vs. UPA). UPA was effective in preventing rupture in the 5 days following treatment, even when administered at the time of the luteinizing hormone (LH) surge (UPA 79%, LNG 14% and placebo 10%). None of the treatments were effective when administered on the day of the LH peak. The median time from treatment to rupture was 6 days during the ulipristal cycles and 2 days in the placebo and LNG/LNG+meloxicam cycles (p=.0015).

Conclusion

Although no EC treatment is 100% effective in inhibiting follicular rupture when administered in the late follicular phase, UPA is the most effective treatment, delaying ovulation for at least 5 days in 59% of the cycles. LNG is not different from placebo in inhibiting follicular rupture at this advanced phase of the cycle. No treatment was effective in postponing rupture when administered on the day of LH peak.     

A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs

Objectives

We explored levonorgestrel (LNG) concentrations, bleeding patterns and endometrial thickness in women with epilepsy (WWE) initiating an LNG-intrauterine device (IUD) co-administered with antiepileptic drugs (AEDs).

Intrauterine contraception for adolescents aged 14-18 years: a multicenter randomized pilot study of Levonorgestrel-releasing intrauterine system compared to the Copper T 380A

Background

Intrauterine contraception can provide adolescents with effective, long-term contraception as well as with other health benefits. In adult populations, intrauterine contraception rates highly in patient satisfaction and safety. It is rarely prescribed to adolescents because of limited data.

Study Design

Multicenter, randomized, controlled, participant-blinded pilot study of 14-18-year-old females assigned to the Copper T 380A intrauterine device or the Levonorgestrel Intrauterine System. Participants were followed up for 6 months following insertion.

Results

We enrolled 23 participants; 12 received the Levonorgestrel Intrauterine System, and 11 received the Copper T 380A. At 6 months, the continuation rates were 75% for the Levonorgestrel Intrauterine System users and 45% for the Copper T 380A users (p=.15). Two Copper T 380A users experienced partial expulsion. Heavy bleeding and pelvic pain were the most commonly reported side effects. Participants rated both methods favorably.

Conclusions

This study shows that at 6 months, though not statistically significant, adolescent continuation rates trended towards being greater with the Levonorgestrel Intrauterine System compared to the Copper T 380A. These pilot data will be helpful in the design of a larger trial of intrauterine contraception use among adolescents.     

Shared negative experiences of long-acting reversible contraception and their influence on contraceptive decision-making: a multi-methods study

Objectives

We explored how negative stories about long-acting reversible contraception (LARC) — defined as a firsthand negative experience with LARC shared directly with the study participant — were involved in participants’ decisions about whether to use LARC following abortion, and how counseling affected the influence of negative LARC stories on contraceptive choices.

Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial

Objective

This trial was designed to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4–8 weeks after delivery.

Study design

This randomized controlled trial was conducted at two urban medical centers. Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4–8 weeks. We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery.

Results

Forty-two women were randomized, 20 into the postplacental group and 22 in the delayed group. Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group (60.0% vs. 40.9%, p=.35), this difference was not statistically significance. Expulsion was significantly more common in the postplacental group (20.0% vs. 0%, p=.04). There were significant differences between the two sites in baseline population characteristics, follow-up and expulsion. The trial did not answer the intended question as it was halted early due to slow enrollment.

Conclusions

Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months. Moreover, it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion.

Implications

Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period. While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months, our trial was insufficient to definitively test our hypothesis.     

Pharmacy-based interventions for initiating effective contraception following the use of emergency contraception: a pilot study

Objectives

In Scotland most women get emergency contraception (EC) from pharmacies. Pharmacists currently cannot provide effective ongoing contraception after EC. In this pilot study, we aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC.

Study design

This is a pilot study of women presenting for levonorgestrel EC to community pharmacies in Edinburgh, UK, in 2012. Pharmacies were cluster randomized to provide either standard care or one of two interventions: (a) one packet of progestogen-only pills (POPs), giving women 1 month to arrange ongoing contraception; (b) invitation to present the empty EC packet to a family planning clinic (FPC) for contraceptive advice (rapid access).

Results

One hundred sixty-eight women were recruited from 11 pharmacies to POP (n=56), rapid access (n=58) and standard care (N=54) groups, respectively. Telephone follow-up was conducted successfully in 102 women (61%) 6–8 weeks later to determine current contraceptive use. In the POP arm, 35/39 (90%) women used the pills provided, and 9/28 women (32%) in the rapid access arm attended the FPC. The proportion of women using effective contraception at follow-up was significantly greater in both POP [56% (22/39), p=<0.001] and rapid access [52% (13/25), p=0.006] groups compared to standard care [16% (5/31)]. The relative probability of a woman using an effective method of contraception versus barrier/no method, after use of EC, was 3.13 [95% confidence interval (CI), 1.90–5.13] in the POP group and 2.57 (95% CI, 1.55–4.27) in the rapid access group.

Conclusions

This promising pilot study suggests that simple pharmacy-based interventions may increase the uptake of effective contraception after EC. A larger study is required to provide further validation of these findings.

Implications statement

For women obtaining EC from a pharmacy, simple interventions such as supplying 1 month of a POP, or offering rapid access to a FPC, hold promise as strategies to increase the uptake of effective contraception after EC.     

Effects of Mirena (levonorgestrel-releasing intrauterine system) and Ortho Gynae T380 intrauterine copper device on lipid metabolism—a randomized comparative study

Background

This study aims to assess the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) on lipid metabolism in an Asian population using Ortho Gynae T380 copper containing (nonhormonal) intrauterine device (IUD) as a control.

Study Design

Ninety-two healthy women requesting IUD for contraception were randomly allocated to the two groups and were followed up at 6-, 12- and 18-month intervals. Serum concentrations of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), apolipoprotein A-I (Apo A-I) and apolipoprotein B were measured pre insertion and at each visit following insertion.

Results

There was a marginally significant reduction in TC level in the LNG-IUS group. HDL-C showed a significant reduction in the LNG-IUS group at 6 months but reverted back to its preinsertion value by 1 year. TG, LDL-C and the cholesterol ratios remained stable. Levels of Apo A-I and B also showed no significant reduction in both groups, and their ratios remained stable and insignificant.

Conclusion

In this randomized comparative study among our local Asian population, it is assuring to note that the LNG-IUS does not have any adverse effects on lipid metabolism.