The Division of Family Planning has many active clinical trials involving the development and assessment of contraceptive methods; these studies range from Phase I to Phase IV. We also study approaches to improved abortion care and innovations in reproductive health screening. Research interests also include HIV and reproductive health assessments and interventions in developing country settings.
The Division is one of twelve centers nationwide that participate in the Contraceptive Clinical Trials Network (CCTN) of the National Institute of Health, developing new methods of birth control. The division just-completed a network study that evaluated the contraceptive effectiveness of several candidate microbicides that may provide protection against both pregnancy and against HIV infection, and the effectiveness of a new hormonal contraceptive ring. All of our research is patient-centered and is designed to bring contraceptive innovations to patients as quickly as possible. New trials in the CCTN include:
- A phase III, multicenter, randomized, study of the safety and contraceptive efficacy of a new female condom and
- A multicenter, randomized, double-masked PhaseI/II study of the safety and pharmacokinetics/pharmacodynamics of two doses of a novel progestin-only contraceptive patch.
The Division is also home to pilot studies, foundation sponsored projects, as well as larger multi-center trials funded by NIH and industry sponsors. Current and recent trials include:
- A study of partner influence on contraception;
- A prospective cohort study of surgical techniques for second-trimester pregnancy termination;
- A randomized, open-label comparative multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive;
- Multi-center RCT to investigate plasma & RBC folate and homocysteine levels in OCP containing folate compared to OC alone;
- Impact of pack supply on oral contraceptive continuation;
- Pilot and RCT to evaluate the efficacy of text-message reminders on OC continuation;
- Postabortal IUD insertion, and many other ongoing projects.
Defining the Link Between Oral Contraceptives and Blood Clots
The risk of developing a blood clot in a vein (a venous thromboembolism) rises during the first three months after beginning combination oral contraceptive use, and then gradually decreases over the next nine months. Studies have shown that elevated endogenous thrombin potential (ETP)—the balance between pro- and anti-coagulant forces operating in plasma—is a risk factor for clotting.
To investigate the link further, a research team led by Carolyn Westhoff, MD, MSc, Director of Family Planning and Preventive Services, evaluated the extent of ETP changes during the initial cycle of an oral contraceptive that combined ethinyl estradiol and levonorgestrel. The researchers found that the increases in ETP during the first cycle were substantial, but because the laboratory findings are preliminary, the results are not directly useful for clinical recommendations. More laboratory and clinical studies are needed to corroborate these findings and judge the clinical utility of ETP testing.