This protocol builds on our successful execution of the RAPID EC (RCT Assessing Pregnancy
with Intrauterine Devices for Emergency Contraception) trial, which demonstrated the LNG 52
mg IUD to be noninferior to the copper IUD for EC. LNG 52 mg IUD users in the study had a
one-month EC pregnancy rate of 0.3% (95% CI 0.01-1.7%). Within months of publication of these
results in the New England Journal of Medicine, Planned Parenthood Federation of America's
(PPFA) National Medical Committee used our data to adopt new contraceptive care guidelines.
Today, those presenting for care at any of the over 600+ PPFA health centers in the U.S. can
be provided the LNG 52 mg IUD for 2 new situations when they have a negative pregnancy test:
- EC, within 5 days of unprotected intercourse (UPI) and; 2) Non-EC same-day start, at any
point in the menstrual cycle without UPI in the last 5 days. PPFA's clinical application of
these data removed an access barrier and will decrease people's risk of undesired pregnancy.
However, the LNG 52 mg IUD prescribing information and Centers for Disease Control and World
Health Organization clinical guidelines, which guide clinical care outside of PPFA, currently
oppose placement for both of these situations. The current recommendation for those not
within the first 7 days of the menstrual cycle is to delay LNG IUD placement and return after
the next menses start. We found in the RAPID EC trial and other analyses that the risk of
pregnancy appears negligible when initiating an LNG 52 mg IUD for EC or same-day start,
provided the urine pregnancy test is negative. This study assesses reproducibility of RAPID
EC's findings by determining the effectiveness of the LNG 52 mg IUD to prevent pregnancy in
real-world settings where users select their treatment (and are not randomized to it as in
RAPID EC trial). We will test reproducibility and generalizability in a larger, more diverse
population to assess the appropriateness of defining the interventional IUD as a new standard
of care and how PPFA guidelines should be revised before influencing guidelines more broadly.
EC: Pills, the copper IUD, and the importance of adding the LNG 52 mg as a new EC option
Globally, people use EC methods to decrease their risk of pregnancy after UPI because of
method failure or not using contraception. EC use in the U.S. is common and increasing. In
2002, 4% of pregnancy capable people ever reporting sexual intercourse had used EC. This
figure climbed to 20% by 2015, and to 27% by 2017 for urban women. Although anyone can obtain
oral EC without a prescription, IUDs can be desirable for EC because they are much more
effective than EC pills and provide ongoing highly effective contraception for years if
desired. So, while the majority of EC users do not want an IUD it is an important option with
distinct benefits for those that do.
In the U.S., the Food and Drug Administration (FDA) has approved only two methods of EC: oral
LNG and oral ulipristal acetate. A third method, the copper IUD, is an evidence-based EC
approach and the most effective (failure rate <0.1%), with pregnancy risk an order of
magnitude lower than the oral methods. However, those selecting an IUD for long-term
contraception are more likely to choose the LNG over the copper IUD. Adding the LNG 52 mg IUD
as another EC option, highly effective for both EC and ongoing contraception, is a
significant advancement. Especially given that a greater number of contraceptive options
presented to an individual is associated with increased method satisfaction, continuation,
and decreased unintended pregnancy. The RAPID EC trial demonstrated efficacy for the first
new EC method since the 2010 FDA approval of oral ulipristal acetate.
Oral EC methods are less effective in two critical situations where IUD EC efficacy does not
change.
One, for people with a Body Mass Index (BMI) >30 kg/m2 the risk of pregnancy risk after oral
EC rises to 2.6% for ulipristal users and to 5.8% for oral LNG EC users, approaching no
effect. However, IUD pregnancy risk does not change with weight for either EC (half of RAPID
EC participants had a BMI 25 or greater) or ongoing contraception. Public health significance
of this issue increases as the mean BMI for U.S. women of reproductive age rises toward 30
kg/m2. Two, the absolute highest risk of pregnancy for oral LNG EC users, 7.3%, is in women
reporting additional acts of intercourse later in the cycle after EC use. This elevated risk
of pregnancy is eliminated when an IUD is placed for EC as supported by a RAPID EC secondary
analysis.
Same-day LNG IUD start reduces ongoing pregnancy risk and promotes autonomy.
"Same-day start" describes the need to provide people their desired method of contraception
on the day they present for care. Meeting people's needs on the day they present for care is
important because requiring two visits for IUD placement for STI testing, which is
unnecessary to reduce infection risk, or additional counseling sessions, results in only half
(54%) returning to get the IUD. Adolescents, post-abortion, and postpartum patients who
receive long acting reversible contraceptive (LARC) methods when presenting for care, rather
than returning later, are more likely to get their desired method and have lower pregnancy
rates. Same-day LARC access is supported by The American College of Obstetricians and
Gynecologists, but is only provided by 29% of U.S. Obstetrician Gynecologists.
Provision of the LNG IUD for EC and same-day start use is an important step in removing
access barriers to contraception and providing people with the method they desire at the time
that they present for care. We hypothesize both reproducibility of the initial results and
greater generalizability. This effectiveness study will expand on the previous trial,
conducted in one geographic area, by enrolling a heterogeneous participant population from 8
U.S. PPFA affiliates, providing geographic, racial, ethnic, and gender diversity.
