Quick Start Insertion of Mirena and ParaGard

1. STUDY PURPOSE AND RATIONALE Intrauterine devices (IUDs) are an effective yet
underutilized form of contraception in the United States. Only 5.5% of women age 15-44
reported using them in 2006-2008(Mosher 2010). Due to historical practices or prescribing
recommendations, IUD insertion may be delayed if women must wait for results of screening
for sexually transmitted infections (STIs) or for the beginning of their menstrual cycle.
Such barriers are not as prevalent for other contraceptive methods. Initiation of oral
contraceptive pills (OCPs), the vaginal ring, transdermal patches, and depot
medroxyprogesterone acetate injection, with emergency contraception (EC) as indicated, is
safely done on the same day of a woman's visit to her provider. This "Quick Start" approach
improves access to birth control and has been well studied at the Family Planning Clinic at
Columbia Presbyterian Medical Center and at other institutions (Westhoff 2002, Schafer 2006,
Murthy 2005, Rickert 2007). The investigators providers often extend this practice to IUD
insertion, but outcomes have not been formally assessed. If the investigators can show that
insertion at any time is safe, the investigators can improve access.

There are several concerns surrounding IUD insertion at the time of an initial visit to a
health care provider. One problem with insertion outside the first week of the menstrual
cycle may be "window" pregnancies those that occur during the first cycle with the IUD in
place. For OCPs initiated with the Quick Start protocol, the pregnancy rate is approximately
2% (Westhoff 2007). No data exist for IUDs that insertion during any other part of the cycle
differs with regard to number of window pregnancies. Another theoretical drawback to
immediate IUD initiation is insertion in the setting of an undiagnosed STI. While the risk
of developing pelvic inflammatory disease (PID) is highest in the 20 days postinsertion, the
incidence of pelvic inflammatory disease among IUD users is rare and estimated at between
1:100 to 1:1,000 woman-years (Martinez 2009). Evidence does not support routine screening
for sexually transmitted infections prior to IUD insertion for women at low risk for STIs,
and testing should be done based on local prevalence data (Walsh 1998; Skjeldestad 1996).
For women younger than 26 or with multiple sex partners, screening can be done on the same
day of insertion. However, variation in individual provider practice patterns can be an
additional barrier that delays IUD insertion and puts women at risk for interval pregnancies
while awaiting IUD insertion.

Alterations in cramping, expulsions, and bleeding patterns may or may not be associated with
cycle day of insertion but nonetheless could contribute to satisfaction with and
continuation rates of the IUD. In a 60 month study of TCu380A IUDs in Iran, approximately
25% of women discontinued the method due to bleeding and pain (Jenabi 2006). Another study
done in Kuwait found that irregular or heavy bleeding was a common complaint (Alnakash
2008). Published data on these issues is sparse. Without evidence that alternatives are safe
for the two IUDs that are currently available, physicians may be reluctant to individualize.

An accurate assessment of bleeding patterns after IUD insertion rests on the quality of data
gathered. In 2005, Mishell issued guidelines for standardization of data collection and
analysis of bleeding patterns for combined hormone contraceptive trials, and noted the need
for prospective comparative studies of the accuracy of electronic data collection versus
paper diaries (Mishell, 2005). There are no published data comparing the quality and
quantity of information obtained using these two methods, but text messages are increasingly
used to collect data in clinical trials. This study affords us the opportunity to compare
this new modality with existing methods.

Inclusion Criteria:

- Receiving Mirena or ParaGard intrauterine device for contraception

- Speak English or Spanish

Exclusion Criteria:

- Do not use a cell phone

- Unable/unwilling to fill out daily bleeding diaries