Best of 2020: ACR 2020 Reproductive Guidelines - Contraception & Counseling Save

Editor's note: this article originally appeared September 8, 2020 and is being shared again as part of RheumNow's "Best of 2020". 

The American College of Rheumatology (ACR) established a guidelines committee that consisted of both patients, rheumatologists and maternal-fetal health experts. After a a systematic review of the medical literature regarding contraception, assisted reproductive technology (ART), fertility preservation, hormone replacement therapy (HRT) pregnancy, lactation, and medication use in rheumatic disease (RMD) patients, they published 12 good practice statements and 131 recommendations for reproductive health care in RMD patients.

Such a guidelines document is strongly needed as many RMD patients are young women, many who desire pregnancy, yet many who have hesitancies rooted in fear over the effect their disease or medicines will impart on their pregnancy.  Moreover, pregnancy in RMD women have serious adverse outcome for both mother and child.  Lastly, for most rheumatologists there is a knowledge/comfort deficit when it comes to counseling patients on contraception, family planning and DMARD or biologic management in the context of pregnancy. 

This ACR guideline document is based on a literature review that settled on 289 studies as evidence for these recommendations. 

In the first of this 3 part series we will put forth the 12 clinical practice statements (suggestions) and will present recommendations (and good clinical practice statements) on contraception. For information regarding assisted reproductive technology (ART), HRT or fertility preservation with cyclophosphamide therapy, you should refer to the full manuscript.

Good Clinical Practice Statements

1. In women with RMD who are of childbearing age, we suggest discussing contraception and plans for pregnancy at an initial or early visit and when initiating treatment with potentially teratogenic medications.   
2. In women with RMD without SLE and without positive aPL we suggest treating with HRT according to the guidelines for the general postmenopausal population.
3. In men with RMD receiving cyclophosphamide therapy who have no immediate plans to father a child we suggest - where possible and when future conception is desired - proceeding with sperm cryopreservation, ideally prior to initiating cyclophosphamide therapy.
4. In women with RMD without SLE and without positive aPL we suggest treating with HRT according to the guidelines for the general postmenopausal population
5. In women with RMD considering pregnancy or who are pregnant we strongly suggest counseling patients that maternal and pregnancy outcomes are better when illness is quiescent / low activity before pregnancy
6. Co-management by a rheumatologist or other physician with relevant expertise throughout pregnancy is preferred
7. In women who are pregnant, We strongly suggest monitoring laboratory tests for disease activity at least once per trimester during pregnancy. 
8. In men with RMD who are planning to father a child, we suggest discussing the use of medications prior to attempting to conceive a pregnancy.
9. In men with RMD who are initiating treatment with medications that may affect fertility (e.g. cyclophosphamide), we suggest discussing future pregnancy plans.
10. In RMD women, we suggest discussing the use of medications prior to attempting to conceive; we also suggest discussing future pregnancy plans when initiating treatment with medications that may affect fertility such as cyclophosphamide.
11. In women with inadvertent exposure to teratogenic medications during pregnancy, we strongly suggest immediate medication discontinuation and referral to a maternal-fetal-medicine specialist or genetics counselor.
12. Women should be encouraged to breastfeed if desired and possible. Disease control should be maintained with medications compatible with lactation and risks/benefits reviewed with each patient for her particular situation.

Contraception

• Discuss contraception and pregnancy planning at initial or early visit with women of reproductive age and counsel regarding efficacy and safety. Recommend barrier methods if more effective methods are contraindicated. Recommend emergency (post-coital) contraception when necessary.
• In women with RMD who are of childbearing age, we suggest discussing contraception and plans for pregnancy at an initial or early visit and when initiating treatment with potentially teratogenic medications. 
• Counseling regarding contraceptive methods for each particular patient should be based on efficacy, safety, and individual values and preferences.
• In women with RMD for whom use of other, more effective forms of birth control are contraindicated, we suggest using barrier methods of contraception as birth control over other less effective options or no contraception.
• In uncomplicated RMD (without SLE and without positive aPL): we strongly recommend using hormonal contraceptives or IUDs over other less effective contraceptive options or no contraceptive method.
• We conditionally recommend using IUDs or progestin subdermal implant over other hormonal contraceptive options.
• In patients with stable (low disease activity) SLE without positive aPL: We strongly recommend using estrogen progestin pill or vaginal ring, progestin-only contraceptives or IUDs over other less effective contraceptive options or no contraceptive method. 
• We conditionally recommend using IUDs and progestin implant and the transdermal estrogen-progestin patch over other hormonal contraceptive options.
• In patients with SLE where level of disease activity is moderate or severe (including active nephritis), we strongly recommend using progestin-only (progesterone pill, progestin  implant or DMPA) or IUD contraceptives and avoiding use of combined estrogen-progestin contraception.
• Positive aPL: In women with RMD with positive aPL, we strongly recommend against using combined estrogen-progestin contraceptives AND strongly recommend using IUDs (copper or progestin) or a progestin-only pill over other hormonal contraceptive options. 
• In women with RMD who are on immunosuppressive therapy and desire an IUD, we strongly recommend the IUD (copper or progestin) as an appropriate contraceptive. 
• For reversible contraception in women with RMD on mycophenolate mofetil or mycophenolic acid, we conditionally recommend use of an IUD (alone) or use of two forms of alternative contraception.

Contraceptive Methods in Women with RMD

Counseling aPL, APS, SS-A & SS-B Positive patients

• In pregnant women with positive aPL who do not meet obstetric or thrombotic APS criteria we conditionally recommend: Treating with prophylactic low dose aspirin during pregnancy and Against treating with prophylactic heparin or LMWH combined with low dose aspirin

  • And against treating with prophylactic hydroxychloroquine during pregnancy. If the patient does not otherwise require hydroxychloroquine. In pregnant women with positive aPL who meet OB-APS criteria and have no history of thrombosis, we strongly recommend treating with prophylactic heparin or LMWH and low dose aspirin.
• In pregnant women with positive aPL who meet OB-APS criteria and have failed standard therapy with prophylactic heparin or LMWH and low dose aspirin, We conditionally recommend against treating with
  • The same (heparin or LMWH combined with low dose aspirin)
  • IVIG in addition to prophylactic heparin and low dose aspirin
  • Prednisone in addition to heparin or LMWH combined with low dose aspirin 
• In women who have met OB-APS criteria, we strongly recommend treating with prophylactic, low-dose anticoagulation during the postpartum period
• In pregnant women with thrombotic APS, we strongly recommend treating with therapeutic heparin and low dose aspirin rather than other non-heparin anticoagulation 
• In pregnant women not otherwise requiring hydroxychloroquine and with obstetric and/or thrombotic APS, we conditionally recommend treating with hydroxychloroquine during pregnancy 
• In pregnant women with anti-Ro/SSA and/or anti-La/SSB antibodies with no history of an infant with congenital heart block or neonatal lupus (risk of complete heart block ~2%) we conditionally recommend obtaining serial (less frequent than weekly, interval not determined) fetal echocardiography starting at weeks 16-18 through week 26.
  • and Treating with hydroxychloroquine during pregnancy
• In pregnant women with anti-Ro/SSA and/or anti-La/SSB antibodies with history of an infant with congenital heart block or neonatal lupus (risk of complete heart block is 13 -18%) we conditionally recommend: Obtaining fetal echocardiography every week starting between weeks 16-18 through week 26.
  • and Treating with hydroxychloroquine during pregnancy
• In pregnant women with anti-Ro/SSA and/or anti-La/SSB antibodies with abnormal fetal echocardiograms, we conditionally recommend:
  • If 1st degree heart block, treating with dexamethasone 4 mg PO daily
  • If 2nd degree heart block, treating with dexamethasone 4 mg PO daily
  • If isolated 3rd (complete) degree heart block (without other cardiac inflammation), against treating with dexamethasone 

While many of the committee's recommendations are conditional, owing to a lack of data or low‐level data, they are intended to better inform rheumatologists as they engage in a shared decision‐making process with their patients of child-bearing potential, those seeking input on family planning and managing patients prior to, during and after pregnancy.