Pregnancy Failure and Miscarriage Overview
Of all recognized pregnancies, 15-20% are spontaneously miscarried and an additional 22% end in induced abortion. Incomplete abortion occurs when products of conception are partially expelled from the uterus; and either spontaneous or induced pregnancy loss can result in incomplete abortion. Women seeking care following incomplete abortion are faced with the inadequacy of existing safe abortion and postabortion care services. In countries where access to safe abortion services is restricted, abortions may be performed by unskilled providers in poor conditions and incomplete abortion is of particular concern.
The occurrence of spontaneous fetal death after the first trimester is difficult to ascertain but one estimate is that, in the United States alone, approximately 125,000 to 190,000 2nd- and 3rd-trimester fetal deaths occur each year. Common therapies for 2nd trimester intra-uterine fetal death (IUFD) include dilatation and evacuation surgery and non-surgical labor-induction agents; their use depends in part on gestational age and provider skills and method preference. At this stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, yet timely evacuation is vital in order to avoid the possibility of serious complications for the woman.
We invite you to learn about our approach to pregnancy failure in the first and second trimesters of pregnancy.
Misoprostol for Treatment of Incomplete Abortion
Traditionally, treatment of incomplete abortion in the first trimester involves either curettage or vacuum aspiration. Though highly effective these surgical procedures require trained providers, special equipment, sterile conditions, and often anesthesia. In settings with limited access to skilled providers and well-equipped facilities, use of misoprostol for medical management of incomplete abortion is an attractive alternative. Research has demonstrated that medical management of incomplete abortion is safe, effective, has a low incidence of side effects, and is highly acceptable to women.
Compelling evidence of misoprostol’s successful use in incomplete abortion has led Gynuity to further research optimal doses and routes of misoprostol administration for this indication and to conduct feasibility studies in a range of settings. Geographically, Gynuity’s research has expanded to Sub-Saharan Africa, Latin America and the Caribbean, and Eastern Europe/Former Soviet Union. Next steps will involve introducing misoprostol in rural settings and documenting its use in lower levels of the health care system.
Misoprostol for Treatment of Intra-uterine Fetal Death in the Second Trimester
Because of the scarcity of well-trained surgical providers, more and more physicians have begun turning to misoprostol as an alternative approach to surgical evacuation of the uterus after fetal death in the 2nd trimester. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or other prostaglandins for this indication in a number of small trials published in the peer-reviewed literature. For many obstetricians, misoprostol has become the accepted standard of care for 2nd trimester intrauterine fetal death. In the absence of more formal study of this treatment, however, dosages are not standardized, routes of administration vary, and other issues, such as timing of doses and total dose have not been settled.
In collaboration with US-based researchers, Gynuity is conducting a study testing, in a randomized, blinded trial, two different doses of misoprostol (200mcg vs. 100mcg) administered buccally as a treatment for fetal death at 14 – 28 weeks’ gestation. The purpose is to establish the lowest safe and effective dose of misoprostol for this indication so that providers may proceed with greater authority and confidence. The data from the study should enable a pharmaceutical entity to register misoprostol for the treatment of IUFD in the second trimester. Gynuity has been awarded orphan drug status for misoprostol for this indication and is able to undertake this research because of our receipt of a competitive award from the US Food and Drug Administration.