Clinical Research – Family Planning
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 (LCS Study)
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 manner. 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 participants.
BEDSIDER.ORG IN POST-ABORTION CONTRACEPTIVE COUNSELING: A MIXED METHODS STUDY
Nearly half of pregnancies among American women are unintended, and about 4 in 10 of these are terminated by abortion. Unmet need for family planning is the cause for induced abortion, and those women seeking induced abortion are a high risk for repeat abortion. Family planning services are of paramount importance to this population, and evidence shows that high-quality family planning counseling and provision of methods prior to discharge from a care facility improve uptake and continuation of methods. In a recent study, oral contraceptive pills, a transdermal patch, or a vaginal ring had a risk of contraceptive failure that was 20 times as high as the risk among those using long-acting reversible contraception (IUD or implant).
This is a mixed methods study, incorporating a randomized controlled trial and a qualitative provider focus group, to evaluate contraceptive counseling aided by http://www.bedsider.org/ in patients seeking first-trimester abortion. Our primary outcome is the uptake of long-acting reversible contraception in women seeking induced abortion.
We plan to randomize preoperative clinic days to either provider counseling aided by Bedsider.org or routine provider counseling, and compare the types of contraceptive methods that are chosen in each group, with the primary outcome being uptake of long-acting reversible contraception (intrauterine device or implant). The secondary outcome is satisfaction with contraceptive counseling in both groups.
We also plan to conduct a qualitative focus group study of provider perspectives of this counseling tool after completion of the randomized trial. Materials related to the qualitative portion of the study will be submitted in a separate amendment.
ETONOGESTREL IMPLANT OR DEPOT MEDROXYPROGESTERONE ACETATE AT THE TIME OF MIFEPRISTONE FOR MEDICATION ABORTION (SaLMA Study)
Contraception after abortion is an important public health issue, as women who have an abortion are at high risk for additional unintended pregnancy. In the context of medication abortion, the standard of care is to administer long- acting reversible contraception including the etonogestrel implant (Implanon), and depot medroxyprogesterone acetate (DMPA) at a follow-up appointment after the abortion. We are conducing a prospective, observational double pilot study to evaluate the satisfaction of subjects who have either DMPA or Implanon given on the first day of medication abortion, as opposed to at a follow-up appointment. Wel also assess the continuation of DMPA and Implanon at 3, 6, 9, and 12 months after initial date of administration. In addition, we count the total days of bleeding after the abortion, follow-up rate for evaluation of completion of medication abortion, and efficacy of medication abortion. Participants are asked to fill out questionnaires during the course of the study and are followed for one year.
ETONOGESTREL IMPLANT AT THE TIME OF MIFEPRISTONE FOR MEDICAL ABORTION (SaLMA-2 Study)
Contraception after abortion is an important public health issue, as women who have an abortion are at high risk for additional unintended pregnancy. If long-acting reversible contraception (including implant contraception) is desired by the woman in the context of medical abortion, the standard of care is to administer it at a follow-up appointment, after the abortion is assessed to be complete. In this study, we aim to expand a cohort of subjects who receive the etonogestrel implant (Nexplanon) on the first day of medical abortion, instead of at a follow-up appointment. We assess the continuation of Nexplanon at 3 months after initial date of administration and patient satisfaction with the time of placement of the etonogestrel implant. In addition, we assess the total days of bleeding after the abortion, follow-up rate for evaluation of completion of medication abortion, and efficacy of medication abortion. A total of 50 participants are recruited. They are asked to fill out questionnaires during the course of the study and are followed for 3 months.
IMPLANON CONTINUATION RATES IN WOMEN WITH POST-ABORTAL VERSUS INTERVAL PLACEMENT
This study will compare women who have Implanon placed in the setting of an abortion versus women who have an interval placement to see if continuation rates differ between these two groups. Implanon is an etonorgestrel subdermal contraceptive implant that is highly effective and lasts for three years. Women who elect Implanon as a contraceptive method will be asked to enroll in a study to determine whether they are still using the method six months and twelve months after placement of the Implanon device. They will be contacted by a phone, email or mail survey asking whether or not they are still using the contraceptive device and what their perceptions are of the device. The data collected will show whether or not women who have had the device placed after an abortion have higher discontinuation rates than women who have it placed at any other time. A nested qualitative study of 20 women will be performed as part of the study for an in-depth assessment of reasons for early discontinuation of the device.
MIFEPRISTONE VERSUS LAMINARIA FOR CERVICAL PREPARATION PRIOR TO SURGICAL ABORTION (SAMi-2 Study)
This is a randomized, unblinded, controlled trial testing two methods of cervical preparation before second trimester surgical abortion (between 15 and 18 weeks). The purpose of this research is to determine if the medications mifepristone and misoprostol work as well as osmotic dilators to open the cervix enough to safely terminate the pregnancy. During this period of pregnancy, cervical preparation is usual, but not uniform, and there are two methods of cervical preparation commonly used. One is the insertion of dilators, usually performed the day before the abortion, which provides primarily mechanical dilation. The other is the use misoprostol placed in the cheek or vagina one or several hours prior to abortion. Both methods have their advocates, however they each have some disadvantages. In a prior study by our group (SAMi-1), another medication, mifepristone, was compared with osmotic dilators for cervical preparation in surgical abortion from 14-16 weeks. This study showed that mifepristone was not worse than dilators for cervical preparation, as well as that, women actually preferred it. Using mifepristone the day prior to abortion would avoid some disadvantages of osmotic dilators, including the discomfort of osmotic dilators and the need for a separate insertion procedure.
The primary outcome of this study is the length of the procedure. Secondary outcomes include amount of dilation achieved, ease of procedure, participant’s assessment of discomfort after mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.
INFLAMMATION OR INFECTION AT THE TIME OF SECOND TRIMESTER ABORTION
It is uncertain whether the methods used for cervical preparation prior to abortion cause inflammation and predispose the woman to infection. In this study, amniotic fluid is sampled before cervical preparation with osmotic dilators and concurrent induced fetal demise, and sampled again 24 hours later just prior to abortion. Fluid is analyzed for white blood cell count and IL-6.
MIFEPRISTONE VERSUS MISOPROSTOL FOR CERVICAL PREPARATION PRIOR TO SURGICAL ABORTION IN NULLIPAROUS WOMEN AT 11 TO 15 WEEKS (MIMI Study)
This is a prospective, double-blind, randomized trial to evaluate if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants who are pregnant women 11 to 15 weeks gestational age are recruited. Half of them receive mifepristone and the other half misoprostol. We measure the amount of cervical dilation achieved right before a surgical abortion to determine if mifepristone is significantly different than misoprostol as a cervical preparant at this stage of pregnancy. We expect that mifepristone will work better than misoprostol for this purpose. We hope to generate information about mifepristone so that women and their health care providers can know more about mifepristone as an option for cervical preparation before surgical abortion.
CERVICAL PREPARATION BEFORE DILATION AND EVACUATION AT 16-24 WEEKS GESTATION: MULTICENTER RANDOMIZED TRIAL COMPARING OSMOTIC DILATORS ALONE TO DILATORS PLUS ADJUNCTIVE MISOPROSTOL OR ADJUNCTIVE MIFEPRISTONE (MOD Study)
This is a double-blind, three arm randomized controlled trial comparing osmotic dilators alone, dilators plus buccal misoprostol given 3 hours preoperatively and dilators plus oral mifepristone given at the time of dilator placement for women 16 to 24 weeks gestation undergoing D&E. Our primary outcome is D&E operative time. Secondary outcomes include comparisons of initial cervical dilation, ability to complete the D&E on the first attempt, need for mechanical dilation and ease of dilation if required, complications, pain, side effects and patient and provider acceptability. Mifepristone may be more effective and better tolerated than misoprostol according to previous research on cervical preparation. This study aims to verify this hypothesis.
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