Embryo Project Encyclopedia

Isotretinoin is a molecule and a byproduct (metabolite) of vitamin A, and in greater than normal amounts in pregnant women, it can cause fetal abnormalities including cleft lips, ear and eye defects, and mental retardation. Isotretinoin is commonly called by its trade name Accutane, and it's a chemical compound derived from vitamin A, or retinoic acid. Doctors prescribe isotretinoin to treat severe acne. For pregnant women, too much vitamin A or isotretinoin can also cause greater than normal rates of stillbirths and fetal disintegrations after the ninth week of gestation. Women who use isotretinoin during the first trimester of their pregnancies, even in small amounts, risk defects to their fetuses such as external ear malformations, cleft palates, undersized jaws (micrognathia), a variety of heart defects, buildups of fluids inside the skulls that leads to brain swelling (hydrocephalus), small heads and brains (microcephaly), and mental retardation.

Isidore Geoffroy Saint-Hilaire studied anatomy and congenital abnormalities in humans and other animals in nineteenth century France. Under the tutelage of his father, Etienne Geoffroy Saint-Hilaire, Isidore compiled and built on his father's studies of individuals with developmental malformations, then called monstrosities. In 1832, Isidore published Histoire generale et particuliere des anomalies de l'organisation chez l'homme et les animaux (General and Particular History of Structural Monstrosities in Man and Animals), in which he defined the term teratology as the study of birth defects and deformities. Isidore Geoffroy Saint-Hilaire established teratology as a legitimate branch of scientific study.

In Maureen Kass v. Steven Kass (1998), the Court of Appeals of New York in Albany, New York, ruled that the state should generally consider IVF consent forms signed by participants in an in vitro fertilization (IVF) program valid, binding, and enforceable in the event of a dispute. The court indicated that decisions regarding the handling of cryopreserved pre-zygotes, often called preembryos, contained within these consent forms should be upheld. Although Steven and Maureen Kass had signed IVF consent forms agreeing to donate unused preembryos to research, during their divorce Maureen argued for custody of the preembryos. The New York Court of Appeals ruled in favor of Steven Kass and concluded that the informed consent forms signed by the former couple had clearly manifested the coupleÕs mutual intent to donate any preembryos to research in the event of a dispute.

The article Experimental Studies on Congenital Malformations was published in the Journal of Chronic Diseases in 1959. The author, James G. Wilson, studied embryos and birth defects at the University of Florida Medical School in Gainesville, Florida. In his article, Wilson reviewed experiments on birds and mammals from the previous forty years to provide general principles and guidelines in the study of birth defects and teratogens, which are things that cause birth defects. Those principles included what species are convenient for conducting teratological research, what principles act in human embryological and fetal development, and what agents impact those processes. Wilson's article was one of the first attempts in the twentieth century to synthesize basic research conducted in the field of teratology. The article helped to establish teratology as a field in medicine during the twentieth century.

Thalidomide is a sedative drug introduced to European markets on 1 October 1957 after extensive testing on rodent embryos to ensure its safety. Early laboratory tests in rodent populations showed that pregnant rodents could safely use it, so doctors prescribed Thalidomide to treat morning sickness in pregnant women. However, in humans Thalidomide interfered with embryonic and fetal development in ways not observed in rodent tests. Pregnant women who take Thalidomide are at grater than normal risk for spontaneous abortion and for giving birth to children with developmental anomalies such as shortened, absent, or extra limbs, as well as a variety of heart, ear, and internal organ defects. The failure of rodent models to inform scientists of Thalidomide's teratogenicity in humans ignited debate about the proper use of cross-species testing during drug development.

In 2014, the United States Food and Drug Administration published the Pregnancy and Lactation Labeling Rule to amend previous guidelines for the prescription of drugs for pregnant and lactating women. The 2014 Pregnancy and Lactation Labeling Rule was intended to increase the safety and efficacy of prescription drugs by making drug labels easier for physicians to understand and utilize. The Pregnancy and Lactation Labeling Rule restructured drug labels and required that they include narratives describing drug-associated risks to women and fetuses, rather than using complicated letter categories. The Pregnancy and Lactation Labeling Rule changed the framework for drug labeling, making it easier for doctors to prescribe safe and effective drugs to pregnant women, lactating women, and people of reproductive capacity.

The objective of this project was to determine the importance of informed consent laws to achieving the larger goal of dismantling the right to abortion. I found that informed consent counseling materials in most states contain a full timeline of fetal development, along with information about the risks of abortion, the risks of childbirth, and alternatives to abortion. In addition, informed consent laws for abortion are based on model legislation called the “Women’s Right to Know Act” developed by Americans United for Life (AUL). AUL calls itself the legal architect of the pro-life movement and works to pass laws at the state level that incrementally restrict abortion access so that it gradually becomes more difficult to exercise the right to abortion established by Roe v. Wade.

The North Carolina state legislature passed The Woman’s Right to Know Act in 2011, which places several restrictions on abortion care in the state. The Woman’s Right to Know Act, or the Act, imposes informed consent requirements that physicians must fulfill before performing an abortion as well as a twenty-four hour waiting period between counseling and the procedure for people seeking abortion, with exceptions for cases of medical emergency. Then-governor of North Carolina Beverly Perdue initially vetoed House Bill 854, which contained the Act, but the state legislature overrode her veto to pass the bill. In response to a lawsuit that the American Civil Liberties Union, or ACLU, and other organizations filed in 2011, a US district court judge blocked the law’s ultrasound mandate from going into effect and a later court case determined that the mandate was illegal. With the passage of the Act in North Carolina, the state passed several abortion regulations and mandated that abortion providers must inform women of specific details about their pregnancy before performing the abortion procedure.

In January 2014, Mary Gatter and colleagues published “Relationship between Ultrasound Viewing and Proceeding to Abortion” in Obstetrics and Gynecology hereafter “Ultrasound Viewing.” As of 2021, ten states require women to undergo an ultrasound before they may consent to having an abortion. Self-described pro-life organizations assert that viewing an image of the fetus will dissuade women from having an abortion. The authors reviewed women’s medical records from over fifteen thousand visits to one abortion provider in 2011.The authors determined viewing an ultrasound image did not change the minds of women who were already highly certain that abortion was the right decision, challenging the idea that mandatory ultrasound viewing has any effect on women’s decision to have an abortion.

Teratogens are substances that may produce physical or functional defects in the human embryo or fetus after the pregnant woman is exposed to the substance. Alcohol and cocaine are examples of such substances. Exposure to the teratogen affects the fetus or embryo in a variety of ways, such as the duration of exposure, the amount of teratogenic substance, and the stage of development the embryo or fetus is in during the exposure. Teratogens may affect the embryo or fetus in a number of ways, causing physical malformations, problems in the behavioral or emotional development of the child, and decreased intellectual quotient IQ in the child. Additionally, teratogens may also affect pregnancies and cause complications such as preterm labors, spontaneous abortions, or miscarriages. Teratogens are classified into four types: physical agents, metabolic conditions, infection, and finally, drugs and chemicals.