Neena T Qasba, MD

Dr Qasba is Family Planning Fellow, Department of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine, New Haven, Connecticut.

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 is Family Planning Fellow, Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut. She has no conflict of interest to report in respect to the content of this article.

 is Section Chief, Family Planning, and Director, Fellowship in Family Planning, Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut. She reports receiving salary/honoraria from Merck.

	As ob/gyns, one of our most important preventative health interventions is providing effective contraceptive care. Family planning allows a woman to choose if and when to have a pregnancy that is planned and hopefully healthy.

	For women with underlying medical conditions, the decision of if and when to become pregnant presents us with greater complexity both in preconception counseling and in selecting a contraceptive method that is safe. The woman with long standing insulin-dependent diabetes with resultant impaired renal function and vascular disease requires careful preconception counseling. This includes understanding the contraindications to common contraceptive methods if she feels that now is not the time to become pregnant.

	For some medications, we can rely on FDA labels to include evidence-based contraindications. This is not the case, however, for many hormonal contraceptive methods. With the FDA’s policy of attaching “class labeling” to categories of medications, all hormonal methods are labeled with the contraindications to estrogen, including the progestin-only methods.

	Fortunately, the US Centers for Disease Control and Prevention (CDC) has developed an evidence-based guide for busy clinicians in approaching contraceptive options. The CDC’s US Medical Eligibility Criteria for Contraceptive Use (MEC), adapted from guidance developed by the World Health Organization (WHO) and first issued in May 2010 and updated in July 2016, provides structured guidance on choosing a safe contraception method based on women’s medical conditions.

 The American College of Obstetricians and Gynecologists (ACOG) has endorsed the US MEC guidelines.

	Contraceptive methods are classified into 4 categories based on their safety in specific medical conditions. The categories are:

	1.  No restriction (method can be used)

	2. Advantages generally outweigh theoretical or proven risks

	3. Theoretical or proven risks usually outweigh the advantages

	4. Unacceptable health risk (method not to be used)

	The CDC also released an update to the US Selected Practice Recommendations for Contraceptive Use (SPR) in July 2016, also based on WHO guidance, as a companion to the MEC.

 While the MEC assists in determining what methods are safe, the SPR focuses on how to use those methods most effectively. It addresses important issues such as:

	• What information or screening is needed before method initiation

	• How to implement “quick start”

	• How soon the woman can rely on the method to protect against pregnancy

	• What routine follow-up, if any, is recommended

	• How to manage common problems and side effects

	Following are 2 cases that will allow you to apply the clinical guidelines of the MEC and the SPR to illustrate their use. We present the most effective contraceptive options first.

Shawna is a 33-year-old gravida 3 para 2+0+1+2 postoperative day 2 from a full-term repeat cesarean delivery. She wishes to wait at least 4 years before having her third and final child. Her body mass index (BMI) is 32 km/m2. She does not have hypertension or other medical problems. She is planning to breastfeed. She has used condoms, withdrawal, and combined oral contraceptives in the past but she is interested in learning about other methods because she previously conceived while taking the pill and had an induced abortion. 

Shawna has 3 main issues to consider when selecting a safe contraceptive: obesity, breastfeeding, and postpartum venous thromboembolism (VTE) risk (Table 1). 

	Intrauterine devices (IUDs) are Category 1. The mechanism of contraceptive action of copper and hormonal IUDs is independent of systemic hormonal levels, given that both types work locally within the uterus. Therefore, their efficacy is not affected by body weight.

 The CHOICE project, which had a sample of 6000 women, of whom 35% were obese, revealed no difference in efficacy of the levonorgestrel (LNG) IUD and the copper-T IUD when stratified by BMI.8

	Implant is Category 1. A secondary analysis of the CHOICE project participants revealed a baseline BMI of
	30.1 kg/m2. Of these participants, 28% were overweight and 35% were obese. Their analysis showed no statistically significant difference in the efficacy of BMI.

	The injectable contraceptive depo-medroxyprogesterone acetate (DMPA) is Category 1 for BMI >/=30 kg/m

. In regard to efficacy and weight, DMPA has equal efficacy in normal weight and obese women.

 In a more recent study in obese women using the subcutaneous formulation, no pregnancies were detected among their study population of whom 36% were obese or overweight.

 As pertains to the contraceptive’s effect on weight in obese women, among adult DMPA users, obese women did not gain more weight than nonobese women.

	Combined hormonal contraception (CHC) is Category 2 in the nonpostpartum period for obesity. The 2 main issues with CHC use in obese women are efficacy and VTE risk. The evidence is conflicting as to whether obesity affects combined contraceptive pill efficacy. Obesity itself is a risk factor for noncompliance with combined oral contraceptive pills.

 The studies that do exist do not differentiate between contraceptive method failure due to non-adherence and pharmacokinetics. A recent meta-analysis from Phase 3 clinical trials of combination oral contraceptives (COCs) revealed a hazard ratio of 1.44 (95% confidence interval: 1.06–1.95; 

=.018), suggesting that there is a higher pregnancy rate during COCs use for obese women compared to non-obese women after adjusting for age and race.

 The commercially available contraceptive patch failure rate in women with the highest weight had a similar rate of failure compared to the overall rate (1.0% vs 0.83% in overall group) but the failures clustered in the highest weight category defined as ≥ 90 kg.

 As to the potential increase in risk of VTE, although the absolute risk of VTE remains low among obese users of the combined contraceptive pill, obesity more than doubles the risk of VTE when compared with normal weight women not using hormonal contraception (60 per 100,000 for class 1 obesity (BMI 30–34.9) versus 12–20 per 100,000 in normal weight women.

 This is still a lower risk of VTE among women who are obese and pregnant, which is estimated at 100–200 per 100,000.

	Regarding IUDs, the immediate postplacental placement (<10 minutes of delivery of the placenta) of the copper-T IUD is Category 1 and LNG-IUD is Category 2.

	Both types of IUDs are classified as Category 1 for placement >4 weeks postpartum for all women despite breastfeeding status. Evidence regarding LNG-IUD and breastfeeding has been limited with some mixed results. One randomized, controlled trial reported decreased exclusive breastfeeding in postplacental LNG-IUD compared with delayed postpartum insertion, while another trial reported similar breastfeeding rates between post-placental and delayed insertion.

 Neither study was designed to evaluate breastfeeding continuation. When placed 6 to 8 weeks after delivery, the copper-T IUD compared with the LNG-IUD had no effect on breastfeeding continuation or infant growth parameters.

 ACOG endorses the use of immediate postpartum IUDs.

	An implant is Category 2 for placement earlier than 21 days postpartum and Category 1 for placement later than 30 days postpartum even in women with obesity, which is listed as another risk factor for VTE. ACOG also supports the use of immediate postpartum placement of the subdermal implant.

 The evidence of randomized trials is reassuring, showing no negative effects on breastfeeding parameters including duration or exclusivity of breastfeeding, lactation failure, time to lactogenesis, or milk composition.

	DMPA is Category 2 when given within 21 days postpartum and is Category 1 when given more than 30 days postpartum even in women with obesity, which is listed as another risk factor for VTE.

	In several non-randomized trials, administration of DMPA within 48 hours of delivery did not affect breastfeeding continuation or duration or perception of insufficient milk production.

	CHC is Category 4 when initiated in the 21 days postpartum, then becomes Category 2 when initiated after 42 days postpartum regardless of obesity or other risk factors for VTE. Clinical studies have had differing evidence about the effects on milk volume in women exposed to estrogen-containing contraceptives. The CDC MEC update states that the theoretical effects of combined hormonal contraceptives on breast milk productions are greatest in the first 3 weeks postpartum.

 Studies in the literature have provided more reassurance that CHCs do not affect the onset or duration of breastfeeding nor infant growth parameters.

 In a recent randomized, controlled trial, breastfeeding continuation at 8 weeks was similar between progestin-only and combined oral contraceptive pills when these pills were started at 2 weeks postpartum and infant growth was comparable in both groups.

 So we can conclude that starting CHCs after the recommended 21 days postpartum does not decrease lactation success.

	IUDs (Category 1-2), implants (Category 1), and DMPA injection (Category 1) do not affect the VTE risk postpartum. CHC is Category 4 when started < 21 days postpartum and Category 3 when started 21 to 42 days postpartum and the patient has other risk factors for VTE such as obesity in our patient’s case. Without other risk factors for VTE, CHC is Category 2 when started after 42 days postpartum.

	During the first 6 weeks postpartum, the risk of VTE is increased to 21.5-fold to 84-fold when compared to non-postpartum women.

 After 42 days, CHC are Category 1 for non-breastfeeding postpartum women without other additional risk factors for VTE.

 However, a delay in initiating contraceptives should be weighed against the risk of return of ovulation and unintended pregnancy, especially in those women who are not exclusively breastfeeding for whom return of ovulation may be as early as 27 days or as late as 6 weeks.

	Shawna chooses to start the etonogestrel subdermal implant. The implant is MEC Category 1 (obesity, postpartum) and 2 (breastfeeding <21 days postpartum).

	Let us see how the SPR guidelines apply on timing, need for back-up contraception after initiation of method, need for screening tests prior to with initiation of method, or follow-up.

	The implant can be inserted at any time the provider is reasonably certain that the woman is not pregnant.

One of the criteria is if she is within 4 weeks postpartum.

 With changes in billing and reimbursement policies, many practices are now able to offer patients inpatient postpartum initiation of IUDs and the implant.

	If the implant is inserted immediately postpartum prior to hospital discharge, no back-up contraception method is required.

	In healthy women, no tests or exams such as a Pap smear or screening for sexually transmitted infections (STIS) are required prior to implant insertion. Some women may perceive weight gain after implant insertion. However, recent evidence from the CHOICE project, however, demonstrated that the implant is not associated with weight gain.

 Obtaining a baseline weight and BMI could help correlate perceived weight gain with objective data.

	No routine follow-up is required; however, a woman should seek medical advice if she wants to discuss any side effects or problems she has experienced with her contraceptive method. Assessment of a woman’s satisfaction with her contraceptive method and any changes in health status or initiation of medications should be on-going to confirm the safety of her contraceptive method. The only Category 4 condition for the implant is current breast cancer. If this patient were to develop breast cancer, the implant should be removed.

	Shawna has the implant inserted postpartum before being discharged home with her newborn and she does well postpartum. She is reminded to attend her routine postpartum visit and well woman exams. She is reminded that the implant has enough hormones to prevent pregnancy for up to 4 years but can be removed any time before that if desired.

Jillian is a 23-year-old gravida 0 who desires to initiate a new contraception method. She uses condoms 100% of the time but 2 days ago a condom broke. Her last menstrual period was 2 weeks ago and her urine pregnancy test is negative. She has a history of migraine headaches and history of pelvic inflammatory disease (PID) 3 years ago. She does not desire to become pregnant as she just started a new job and is looking to go back to school. What are the contraceptive options available for her? She has 4 main issues in selecting safe contraception: need for emergency contraception, nulliparity, headaches, and a history of PID (Table 2). 

	Emergency contraception (EC) should be provided as soon as possible after unprotected intercourse for women wishing to prevent pregnancy. The copper IUD is the most effective form of emergency contraception. It can be inserted up to 5 days after unprotected intercourse to prevent pregnancy in women without other contraindications to IUDs and it can be used up to 10 years for ongoing contraception. Oral ulipristal acetate is another effective form of EC; effective up to 120 hours after intercourse it is available by prescription only. Oral levonorgestrel is labeled for use up to 72 hours but has decreasing efficacy from 72 to 120 hours. Levonorgestrel EC pills are available over the counter in all states for women of reproductive age. The CDC MEC identifies no conditions for which the risks of levonorgestrel emergency contraceptive pills outweigh the benefits. Provision of timely copper IUD insertion for EC may be logistically challenging.

	Both types of IUD are Category 2 and all other methods are Category 1.

	Nulliparous women have higher levels of satisfaction with IUDs compared to oral contraceptive pills and high continuation rates.

 There is no increased risk of PID in nulliparous IUD users, nor is IUD use associated with subsequent infertility.

	First, establish exactly what type of headache the patient has. The International Headache Society established criteria for migraine headaches with and without aura.

A migraine without aura needs to be a recurring headache with at least 5 episodes that fulfill the following criteria:

	• Episodes that last for 4–72 hours, and

	• At least 2 of the following: unilaterality, pulsating quality, moderate or severe pain intensity, and

	• At least 1 of the following: nausea/vomiting, photophobia, and phonophobia, not attributed to another disorder.

Symptoms of migraines with aura include the previous list and at least 2 episodes that meet the following criteria:

	• Aura that involves at least one of following: transient visual symptoms (spots, flashes of light) or transient loss of vision or transientsensory symptoms (pins and needles) or transient speech disturbances, and

	• At least 2 of following: unilateral visual symptoms or sensory symptoms, one of more aura symptom develop gradually over 5 minutes, or each aura symptoms lasts between 5 and 60 minutes.

	The copper IUD and the LNG IUD are Category 1. CHC is Category 4 for migraines with aura.

	A migraine headache with aura at any age is Category 4 for initiating estrogen-containing methods due to the association between estrogen, migraines, and increased risk of stroke.

	Both types of IUD are Category 1–2. Past PID is not a contraindication to safe IUD use. The risk of PID from insertion occurs within 3 weeks and is approximately 1.6 per 1000.

 It is not decreased by prophylactic antibiotics or by screening for gonorrhea or chlamydia before insertion.

	IUD use in nulliparous women does not increase the risk of PID and is not associated with future tubal infertility.

 An IUD should not be placed in the setting of acute PID but an IUD does not routinely need to be removed if PID is diagnosed.

	Jillian would like to use the copper IUD for emergency and ongoing contraception. Below we apply the SPR guidelines for her method choice.

	The copper IUD can be inserted at any point if it is reasonably certain that the woman is not pregnant and can be used for emergency contraception.

	The copper IUD is immediately effective so a woman does not need a back-up contraception method.

	Providers should perform a bimanual examination to assess the size and shape of the uterus as well as a speculum exam to assess the cervix for infection or other abnormalities prior to IUD insertion. Providers should screen women for STIs at the time of IUD insertion only if recommended per the CDC STD screening guidelines (6). The CDC recommends that all sexually active women younger than age 26 receive annual gonorrhea and chlamydia screening and women 26 and older be screened if they have risk factors: a new partner, more than one partner, or a partner who has an STI (41).

	No routine office follow-up is required, but women should be taught the warning signs of IUD expulsion (6). When the copper IUD is used for emergency contraception, the woman should do a pregnancy test if her expected menses is delayed by one week or more.

Jillian does well with the copper IUD insertion and her next menses starts as expected in 2 weeks. She is pleased with it for ongoing contraception. 

	1. Food and Drug Administration. Labeling for prescription drugs used in man. 

	2. Food and Drug Administration. Guidance for industry and review staff: labeling for human prescription drug and biological products-determining established pharmacologic class for use in the highlights of prescribing information 2009. 

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM186607.pdf

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Obesity, headaches, PID among conditions that warrant special consideration.

Author | Neena T Qasba, MD

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Safe contraception for women with medical conditions