ACOG & SMFM Guidance on the Use of IUDs and Contraceptive Implants

SUMMARY:  

IUDs and etonogestrel single-rod contraceptive implants are categorized as Long-Acting Reversible Contraception (LARC).  ACOG and other professional and public health entities are calling for reduced barriers and improved access to LARC.  The latest ACOG practice bulletin reviews various LARC options, including clinical considerations such as use in the postpartum period and management in the setting of pelvic infections.  ACOG has also released an updated ‘Quick Coding Guide’ for LARC that can be found in ‘Learn More – Primary Sources’ section.

• Available LARCs
• Clinical Considerations
• Underlying Mechanism
• Adverse Events and Side Effects
• Failure Rates (typical use)

Available LARCs

Copper Intrauterine Device (T380A) 

• FDA approval for 10 years  

Levonorgestrel-Releasing Intrauterine Devices (LNG-IUD) 

• Total of 52 mg of levonorgestrel 
  • 20 micrograms released per day (Mirena) 
    • FDA approved for 8 years 
  • 18.6 micrograms released per day (Liletta)  
    • FDA approved for 8 years  
• Total of 19.5 mg of levonorgestrel (Kyleena) 
  • 17.5 micrograms released per day  
    • FDA approved for 5 years 
• Total of 13.5 mg of levonorgestrel (Skyla)   
  • 14 micrograms released per day
  • FDA approved for 3 years 

Contraceptive Implant

• Subdermal implant with a core containing 68 mg of etonogestrel 

• FDA approved for 3 years

Clinical Considerations

Nulliparous and Adolescents

• LARCs should be offered routinely as safe and effective contraceptive options for nulliparous women and adolescents
• Use of LARCs in adolescents supported by the AAP  
• IUD  
  • MEC category 2 (advantages outweigh risks)
  • Risk of infection is low 
    • No evidence of association with infertility or tubal occlusion   
  • High satisfaction rate based on continuation rates  
  • Expulsion rates may be higher in adolescents vs older women and multiparous vs nulliparous  
  • Like the general population, nulliparous women and adolescents prefer LNG-IUD  
• Implant 
  • MEC category 1 (no restrictions)  
  • Continuation rates higher in adolescents compared to OCPs  

SMFM Guidance on Women at High Risk for Medical Complications (2019)

• Use of LARC is encouraged for women at highest risk for adverse health events as a result of a future pregnancy (GRADE 1B)
• SMFM recommends discussion take place in the prenatal period regarding availability of immediate postpartum LARC and MEC guidelines should be used to determine best method for particular medical conditions (GRADE 1C)
• Counseling should include discussion around expulsion rates but appear to be outweighed by benefit of higher continuation rates (GRADE 1C)
• Providers who intend to utilize immediate postpartum LARC should obtain appropriate training (Best Practice)
• SMFM recommends that for women who are eligible and desire LARC, following a high-risk pregnancy, immediate postpartum LARC should be used vs delayed placement due to overall superior efficacy and cost-effectiveness (GRADE 1B)
• Encourage breastfeeding following immediate postpartum LARC based on current evidence (GRADE 1B)
• SMFM suggests that if a women wishes and is eligible for LARC, but immediate postpartum is not feasible, consider early postpartum placement (GRADE 2C)
• Contraceptive counseling should be (Best Practice)
  • Patient-centered
  • Within a shared decision-making framework 

Timing of Insertion  

• Interval insertion 
  • Insertion may be performed at any time during menstrual cycle if patient is not pregnant  
  • No benefit to inserting during menses 
•  Postabortion LARC Insertion  
  • Routinely offer immediate insertion following first trimester and second trimester abortion (induced or spontaneous)  
• Postpartum LARC Insertion 
  • Offer immediate LARC insertion (IUD and implant) prior to hospital discharge 
  • Higher IUD expulsion rates (10-27%), but cost-benefit supports immediate insertion  
    • Considered ACOG ‘best practice’  
    • Waiting 4-6 weeks may result in barrier to access  
  • Contraindications to IUD placement include chorioamnionitis, endometritis, or puerperal sepsis or ongoing postpartum hemorrhage 

Effect on Breastfeeding  

• Copper IUD: No hormonal concerns  
• LNG-IUD and implant: Studies do not demonstrate a deleterious effect on breast feeding including milk volume/composition, newborn weight or exclusive breastfeeding rates  
• ACOG recommends shared decision making regarding concerns  
  • Patients should be counseled regarding
    • Theoretical risk of reduced duration of breastfeeding
    • Lack of data supporting a negative association

Infection Risk and IUD  

• Asymptomatic women who are at low risk of STDs and have undergone routine screening  
  • No additional screening required at the time of IUD insertion  
• Women who have not been screened for STDs or at increased risk for STDs  
  • Requires CDC-recommended STD screening at the time of a single visit for IUD insertion 
  • Do not delay IUD placement while waiting on results  
  • Treat a positive test without removing the IUD  
• Purulent cervicitis is a contraindication to IUD placement
• If known chlamydia or gonorrhea infection, delay IUD insertion following infection treatment until  
  • Antibiotic course is complete 
  • Symptoms resolved 
  • Pelvic/cervical exam normal 
  • Repeat testing at 3 months for gonorrhea or chlamydia to rule out reinfection  
• Routine antibiotic prophylaxis is not recommended prior to IUD insertion 
• Actinomyces on cytology is an incidental finding 
  • No treatment or IUD removal required if patient is asymptomatic  

Pregnancy with IUD in situ 

• Determine location of pregnancy to rule out ectopic pregnancy  
• Remove IUD if strings visible as benefits outweigh risks  
• If patient opts to retain IUD, counsel regarding risks (which are not totally eliminated by IUD removal) 
  • Abruption, placenta previa, preterm delivery, cesarean delivery, low-birth-weight infants, and chorioamnionitis  
  • Theoretical concerns regarding hormonal exposure with LNG-IUD  
• If a patient opts for termination, remove at that time  

Ectopic pregnancy and IUDs 

• IUDs do not increase the risk and therefore can be offered to women with history of ectopic pregnancy 
• If pregnancy does occur with IUD in place, there is a small increased risk of ectopic pregnancy  

IUD Removal and Menopause 

• Copper IUD: Wait for a year of amenorrhea before removal  
• LNG-IUD: Continue until 50-55 years of age  (as amenorrhea may be related to LNG component)
  • Non-contraceptive benefit of protecting uterus in women using estrogen therapy 
• IUDs do not need to be removed in menopausal women prior to expiration date 

Gyn Procedures with IUD in Place 

• Endometrial biopsy, colposcopy, cervical ablation or excision, and endocervical sampling may all be performed with an IUD in place 

Backup Contraceptive Method  

• Copper IUD 
  • No backup method required  
• LNG-IUD & implant  
  • Backup required (e.g. condoms) for 7 days after insertion unless 
    • Immediately following surgical abortion  
    • 21 days from childbirth 
    • Transition from other reliable method 
    • Within 7 days of LMP for LNG-IUD 
    • Within 5 days of LMP for implant   

KEY POINTS:  

Underlying Mechanism

• LARC devices do not disrupt pregnancy but rather disrupt fertilization  
• Copper IUD 
  • Inhibits sperm migration/viability  
• LNG-IUD 
  • Increased cervical mucus viscosity that prevents sperm entry  
• Implant  
  • Suppresses ovulation 
  • Increased cervical mucus thickening  
  • Alters endometrial lining  

Adverse Events and Side Effects

IUDs 

• Overall complications are uncommon and include expulsion (2 to 10%), method failure and rarely perforation (see ‘Related ObG Topics’ below)  
• Copper IUDs 
  • Heavy Menses and pain  
    • LNG-IUD offers benefit of reduced menses, despite continued ovulation in majority of women  
• LNG-IUD  
  • Minimal hormone released systemically 
  • Hormone related effects include headaches, nausea, breast tenderness, mood changes, acne and ovarian cyst formation  
  • No difference in weight gain compared to copper IUD  

Implants 

• Amenorrhea or menstrual irregularity 
• GI symptoms 
• Hormonal effects: Headaches, breast pain and worsening acne (10-14%)  
• Weight gain (reported in 12% of users) 
  • Literature shows no difference in weight gain at 1 year, after adjusting for confounders, between implant and IUD users 
• Complications related to insertion (1%)  
  • Pain, bleeding, hematoma or incorrect insertion 
• Complications related to removal (1.7%)  
  • Breakage or inability to palpate/locate the implant because of overly deep insertion 
  • Imaging techniques to identify location include high-frequency ultrasonography, MRI, X-ray, CT, or fluoroscopy 

Failure Rates (typical use)

• Copper IUD  
  • 0.8 % (1 year)  
  • 10-year failure rate comparable with that of female sterilization (1.9 per 100 women) 
• LNG-IUD  
  • 20 microgram release:  0.2% (1 year) 
• Implant 
  • 0.05% (1 year)

Learn More – Primary Sources:

ACOG Practice Bulletin 186: Long-Acting Reversible Contraception: Implants and Intrauterine Devices

SMFM Consult Series #48: Immediate postpartum long-acting reversible contraception for women at high-risk for medical complications

ACOG Committee Statement 5: Increasing Access to Intrauterine Devices and Contraceptive Implants

ACOG Program: Long-Acting Reversible Contraception (LARC)

How does TXA Measure Up as a Treatment for Menorrhagia?

BACKGROUND AND PURPOSE: 

• There are several treatments for heavy menstrual bleeding, with good evidence supporting levonorgestrel intrauterine system as a good management option  
  • Not all women will want an IUD  
  • Important to review safety of TXA due to concerns regarding thromboembolic disease  
• Bryant-Smith et al. (Cochrane Reviews, 2018) assessed the effectiveness and safety of antifibrinolytic medications, specifically tranexamic acid (TXA), for the treatment of heavy menstrual bleeding (HMB) 

METHODS: 

• Database search of RCTs comparing TXA and precursor (antifibrinolytic) agents versus  
  • Placebo 
  • No treatment  
  • Other medical treatment 
• Population: Women of reproductive age with menorrhagia  
• Menstrual blood loss were measured by  
  • Objective assessment of mean blood loss in mL (using alkaline haematin method or similar) 
  • Subjective assessment of blood loss using continuous measures such as Pictorial Blood Assessment Chart (PBAC) scores, where over 100 correlates with heavy bleeding using objective methods  
• TXA dose
  • Majority of studies used regular oral dose TXA (3 g/day to 4 g/day) while 4 studies used low-dose TXA (2 g/day to 2.4 g/day)
• Primary outcomes  
  • Menstrual blood loss | Improvement in bleeding | Thromboembolic events 
• Secondary outcomes 
  • Quality of life | Side effects  

RESULTS: 

• 13 RCTs were included, totaling 1312 participants 
• The evidence was very low to moderate quality 
• When compared with a placebo, antifibrinolytics were associated with 
  • Reduced mean blood loss (Mean Difference (MD) -53.20 mL per cycle, 95% CI -62.70 to -43.70; moderate-quality evidence)  
  • Higher rates of improvement (RR 3.34, 95% CI 1.84 to 6.09; moderate-quality evidence) 
• Compared to progestogens, antifibrinolytics were associated with 
  • No difference between the groups in mean blood loss (very low-quality evidence) 
  • Higher likelihood of improvement (RR 1.54, 95% CI 1.31 to 1.80; low-quality evidence) 
  • Fewer adverse events (RR 0.66, 95% CI 0.46 to 0.94; low-quality evidence) 
• Compared to NSAIDs, TXA was associated with 
  • Reduced mean blood loss (MD -73.00 mL per cycle, 95% CI -123.35 to -22.65; low-quality evidence)  
  • Higher likelihood of improvement (RR 1.43, 95% CI 1.18 to 1.74; low-quality evidence) 
• Compared to herbal medicine (Safoof Habis and Punica granatum), TXA was associated with 
  • Reduced mean PBAC score after three months’ treatment (MD -23.90 pts per cycle, 95% CI -31.92 to -15.88; low-quality evidence) 
  • Inconclusive rates of improvement 
• Compared to levonorgestrel intrauterine system, TXA was associated with 
  • Higher median PBAC score (median difference 125.5 points; very low quality evidence)  
  • Lower likelihood of improvement (RR 0.43, 95% CI 0.24 to 0.77; very low quality evidence) 

 CONCLUSION: 

• Antifibrinolytic treatment appears effective for treating menorrhagia compared to placebo, NSAIDs, oral progestogens or herbal remedies 
• However, they appeared less effective compared to levonorgestrel IUD 
  • The authors suggest that if 85% of women improve with levonorgestrel IUD, 20% to 65% of women will do so with TXA 
• Adverse outcomes were hard to quantify due to inadequate amount of data 

Learn More – Primary Sources: 

Antifibrinolytics for heavy menstrual bleeding.