TABLE 1—

Research Needed to Simplify Provision of Contraceptives

Current Practice	Labeling Information	Evidence	Hypothesis	Research Need
Hormonal methods
General health screening by clinician before provision of COCs required in United States and many other countries37–41	Physical examination should be performed (although it can be deferred until after initiation)17	Limited information suggesting women can appropriately self-screen before using COCs25	Women can safely self-screen for COC contraindications	Comparison of self-screen with clinician assessment of appropriateness for COC use
Blood pressure screening by a clinician required before provision of COCs in United States and many other countries37–41	Physical examination should include special reference to blood pressure17	Outside of COC provision, blood pressure self-determination is feasible42,43	Women can safely self-screen for hypertension before obtaining COC refills using a blood pressure kiosk	Acceptability/feasibility trial of self-screening with blood pressure kiosk, as well as comparison of accuracy with clinician blood pressure measurement
Risks usually outweigh advantages of COCs during first 6 months of breastfeeding37,38,41,47	If possible, nursing mothers should be advised not to use COCs17	Studies of effects of COCs on lactation conflicting and of poor quality48; women prefer COCs, and some even stop breast-feeding to initiate use49	COCs have no significant effect on lactation; continuation and satisfaction are higher with COCs than with progestin-only oral contraceptives during breastfeeding	RCT comparing COCs, progestin-only oral contraceptives, and a placebo among breastfeeding women; outcomes: lactation, efficacy, continuation, satisfaction
Women told to initiate use of COCs at beginning of subsequent menstrual cycle (first day or Sunday)38,39,47	First tablet should be taken on the first Sunday after menstruation begins or Day 1 of the menstrual cycle17	Quick start (starting on day of clinician visit, regardless of cycle day) of COCs does not worsen side effects and may improve continuation56,57	Quick start will reduce pregnancy rates among COC users in developing country settings	RCT of quick start vs menstrual start of COCs in developing country settings; outcomes: efficacy, side effects, satisfaction
Women told to begin use of injectables within first 5 days of menses51,60	The first injection of Depo-Provera must be given only during the first 5 days of a normal menstrual period59	Quick start of COCs does not worsen side effects and may improve continuation56,57	Quick start of injectables will not worsen side effects and will improve continuation	RCT of quick start vs menstrual start of injectable contraceptives in developing country settings; outcomes: efficacy, side effects, satisfaction
Injection requires drawing up medication into syringe (and injection by a clinician in many countries)	. . .	Self-injection with simple prefilled syringes (UniJect) has been demonstrated to be acceptable in small trial of Cyclofem58	Use of self-injectable syringes will increase compliance and continuation	Feasibility/acceptability of self- administered UniJect vs clinician injection of contraceptive
Women overdue for injection routinely undergo pregnancy test60	If more than 13 weeks since most recent use of Depo-Provera, pregnancy must be ruled out59	Data equivocal about whether women are able to self-diagnose pregnancy on symptoms alone61,62; home urine pregnancy tests are very accurate63	Women can reliably self-assess for pregnancy when overdue for injection using combination of symptoms and home urine testing	Comparison of self-assessment with clinician assessment of pregnancy in women receiving injectable contraceptives
Barrier methods (diaphragm)
Diaphragms routinely fit by clinician before dispensing67–69	Fitting mandatory65	Limited data suggest fitting not necessary70–72	Modal-sized diaphragm is as effective as fitted diaphragm	RCT of no fitting vs fitting of diaphragm; outcomes: efficacy, continuation, satisfaction
Spermicide routinely recommended with diaphragm67–69	Must be used in conjunction with appropriate spermicide65	Limited data suggest spermicide may not affect efficacy of diaphragm72,78	Use of spermicide does not affect efficacy of diaphragm	RCT of diaphragm with spermicide vs use without spermicide; outcomes: efficacy, continuation, satisfaction
Continuous use of diaphragm not recommended67–69	Continuous wearing of diaphragm for more than 24 hours not recommended65	Limited data suggest that continuous usage is safe and effective78	Continuous use is safe and effective, as well as more accepted by women	RCT of continuous use vs standard use of diaphragm; outcomes: efficacy, continuation, satisfaction
Intrauterine devices
Insertion limited to physicians in some countries owing to regulations or lack of training of midlevel providers79	Should be placed and removed only by health care professionals who are experienced with these procedures83	Nonphysician provision is safe, and complication rates are similar to physician provision80–82	Nonphysicians can safely manage IUDs in all settings	Review of nonphysician provision of IUDs and feasibility trial in several countries where such provision not standard
IUDs rarely inserted immediately postpartum	ParaGard has been placed immediately after delivery, although risk of expulsion may be higher than when ParaGard is placed at times unrelated to delivery 83	Although no RCTs have been conducted, immediate postpartum insertion appears to be safe and effective85	Immediate postpartum insertion is safe, effective, and accepted by women	RCT of immediate vs delayed postpartum IUD insertion; outcomes: efficacy and continuation, including expulsion and percentage of women in delayed group who return
IUDs rarely inserted immediately postabortion	ParaGard can be placed immediately after abortion, although immediate placement involves a slightly higher risk of expulsion than placement at other times83	Insertion of an IUD immediately after abortion is both safe and practical84 (only 1 comparative RCT)	Immediate postabortion insertion is effective and accepted by women	RCT of immediate vs delayed postabortion IUD insertion; outcomes: efficacy and continuation, including expulsion and percentage of women in delayed group who return; feasibility/acceptability of immediate IUD insertion
Postinsertion visit is routine38,41,87–89	After placement, the patient is examined after her first menses to confirm that ParaGard is still in place83	Expulsion is rare (2%–7% of cases), and 80% of expulsions are symptomatic90	Routine follow-up is not necessary; women can be taught to recognize expulsion	Observational prospective cohort study of no follow-up after IUD insertion (with education about recognizing expulsion); outcomes: efficacy (i.e., unrecognized expulsion), satisfaction
Nulliparous women often not considered good IUD candidates because of concerns about side effects (cramping, bleeding, expulsion)91,92	IUDs are not recommended for women at high risk for sexual infection (reference to parity has been deleted in the most recent revision of the labeling)83	For nulliparous women at low risk of STIs, specially designed IUDs are effective and acceptable94	IUDs are both effective and acceptable for nulliparous women	RCT of specially designed IUDs for nulliparous women at low risk of STIs; outcomes: side effects, including pelvic inflammatory disease; continuation; satisfaction
Nulliparous women often not considered good IUD candidates because of concerns about subsequent fertility91,92	IUDs are not recommended for women at high risk for sexual infection83	Subsequent fertility does not appear to be impaired after IUD use91–93	IUD use is not associated with subsequent infertility	Case–control study of association between IUD use and subsequent infertility

Note. COC = combined oral contraceptive; RCT = randomized controlled trial; IUD = intrauterine device; STI = sexually transmitted infection.