Mini-Mirena Study: MULTI-CENTER, OPEN-LABEL, RANDOMIZED STUDY TO ASSESS THE SAFETY AND CONTRACEPTIVE EFFICACY OF TWO DOSES (IN VITRO 12 µG/24 H AND 16 µG/24 H) OF THE ULTRA LOW DOSE LEVONORGESTREL CONTRACEPTIVE INTRAUTERINE SYSTEMS (LCS) FOR A MAXIMUM OF 3 YEARS IN WOMEN 18 TO 35 YEARS OF AGE

PRINCIPAL INVESTIGATOR: Dr. Lynn Borgatta

The objective of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of 2 doses of intrauterine administered LNG. A new levonorgestrel intrauterine contraceptive system (LCS) suitable for use by women 18 to 35 years of age will be studied. Two doses of LCS, 12 µg and 16 µg per day, will be compared to each other in a single blinded manor. The number of pregnancies will be recorded. Pregnancy rate as PI will be calculated as the primary efficacy variable in this study. The secondary efficacy variables – number of IUS expulsions and discontinuations due to problems related to menstrual bleeding or non-bleeding or progestin related side-effects, and the number of overall discontinuations will be recorded and their rates calculated. The study lasts up to 3 years for partisans.

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Miso Prime Study: A PILOT STUDY OF PRIMING BEFORE INDUCTION TERMINATION OF PREGNANCY

PRINCIPAL INVESTIGATOR: Dr. Nilda Moreno

Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours from the start of medication (misoprostol) to expulsion of the fetus. The objective of this study is to evaluate a method of 'priming' on the length of induction termination of pregnancy. "Priming" refers to the use of medication to ready the cervix and uterus so that the uterus is more sensitive to medication and contracts more effectively, and also refers to softening of the cervix so that there is less resistance to dilation. Priming is used extensively before induction of labor for term pregnancy and is also used extensively before surgical abortion in second trimester. We would like to add priming the evening before induction to the usual treatment and evaluate whether the length of the induction process is shortened. Women are admitted to the hosPrincipal Investigatortal in the morning to start misoprostol medication, and unless expulsion occurs within 8-10 hours, need to stay overnight. The study design is to give the priming dose 12 hours before admission. The outcome of interest is the induction time from the first dose on misoprostol in the hosPrincipal Investigatortal to expulsion of the fetus. This study aims to assess whether the use of misoprostol as a priming agent would be beneficial with women who undergo induction termination of pregnancy.

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TEPF Study: TREATMENT FOR EARLY PREGNANCY FAILURE

PRINCIPAL INVESTIGATOR: Dr. Sarah Betstadt

Early pregnancy failure (EPF) is defined as an abnormal pregnancy which will inevitably result in spontaneous abortion or miscarriage. Without any treatment, miscarriage will usually occur in days or weeks. For many years, these pregnancies were managed surgically (uterine asPrincipal Investigatorration or D&C). Recently, expectant management (observation) has increased. In the 1990s, medical management of EPF with misoprostol was first reported. This medicine causes uterine cramPrincipal Investigatorng and cervical dilation to cause miscarriage to happen sooner than with expectant management. We want to assess two ways of using misoprostol (alone and in combination with another medication, mifepristone) to complete miscarriage. Women would be able to have immediate treatment upon enrollment, and would be able to request surgical evacuation after 24 hours if complete miscarriage hasn't occurred by then. Our primary endpoint is the proportion of women who complete their miscarriage within one day.

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IUD Study: INSERTION OF AN IUD AFTER MEDICAL ABORTION

PRINCIPAL INVESTIGATOR: Dr. Sarah Betstadt

Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an IUD at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after 2 weeks (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling.

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BMI Study: RELATIONSHIP OF OBESITY TO OUTCOME OF MEDICAL ABORTION

PRINCIPAL INVESTIGATOR: Julie Mottl-Santiago, CNM MPH

This is a retrospective chart review investigating the relationship of obesity to the outcome of medically induced abortion. We would review charts during 2005 and 2006, anticipating that more than 1200 medical abortions occurred during that time. Medical abortion is usually complete within several days although some women may take a week or more. Some women will require additional medication or observation (~8 %) and about 5% require uterine asPrincipal Investigatorration (D&C). It is unknown whether obese women have a difference in outcomes. This is important because obese women have higher risks if they have a surgical abortion by suction. The primary outcome would be documented completion of abortion within two weeks (women who do not have any surgical procedure) comparing two groups. The first group would be composed of women with BMI below 30. This group include normal weight women (and few underweight) and women who are overweight but not obese. The second group would be women with BMI above 35, which is moderate to severe obesity.