Baylor

Stillbirths account for a large proportion of perinatal mortality. According to annual national vital statistics, the number of stillbirths, defined as fetal deaths at 20 weeks gestation or greater, is similar in magnitude to the total number of infant deaths in the U.S. In 2001, 27,568 infant deaths and 26,373 stillbirths were reported. More than half of these stillbirths are of 28 weeks or more gestation and 20 percent, or about 5000 cases, are term gestation. In addition, the causes of about half of all stillbirths are undetermined.

The stillbirth rate has been reduced dramatically since the 1950s with the introduction of interventions for diabetes, preeclampsia, and Rh isoimmunization. However, while the infant mortality rate declined by about 36 percent between 1985 and 2001, from 10.6 to 6.8/1000 live births, the stillbirth rate declined by only about 17 percent, from 7.8 to 6.5 deaths/1000 live births. Despite this significant and persistent burden of stillbirths, they have remained largely unstudied.

On March 26, 2001, the National Institute of Child Health and Human Development (NICHD) convened a workshop of experts in the field to set a national agenda for stillbirth research (Hankins, Willinger and Spong, 2002). Among the identified gaps in knowledge that hamper progress in this field were problems associated with current data on stillbirths in the U.S. These include: (1) in some jurisdictions the fetal death report is voluntary, and under-reporting of stillbirths is as high as 10-15 percent; (2) the quality and completeness of the fetal death certificates vary, including certification of the cause of death; (3) no standard protocol exists for postmortem investigation of stillbirths, including laboratory, toxicological, and genetic tests; (4) while placental pathology is common, fetal autopsy rates are low; and (5) few geographic, population-based, detailed investigations of reproductive and fetal risks associated with stillbirth have been conducted.

Some of the recent evidence points to the association of repeat fetal deaths with the genetic predisposition for thrombophilias (Factor V Leiden mutation) and genetic conditions (telomere mutations). Novel neuropathology findings of central nervous system insults point to specific findings related to fetal death. Other associations include maternal complications (diabetes, hypertension) and umbilical cord accidents; however, limited case ascertainment leads to a bias in the findings, as only a small portion of stillbirths is autopsied or has detailed testing performed to identify cause of death.

These deaths are devastating to the family. It is hoped that increased knowledge regarding the causes of stillbirths will benefit families who have experienced a loss, pregnant women, and their physicians, and may lead to the development and evaluation of improved clinical and preventive interventions.

The purpose of the study is to evaluate the scope and causes of stillbirth.

Specifically, the study aims to:

1) Determine whether or not stillbirths are underreported/underestimated in vital statistics records

2) Determine whether or not the use of a standardized post-mortem evaluation of stillbirth will determine the cause of the loss in a larger percentage of patients than is currently estimated

3) Determine factors that influence the risk for stillbirth and may be useful in developing intervention strategies for the prevention of stillbirth.

Other

There is a potential risk of bruising and small discomfort asociated with drawing blood from the vein.

The maternal interview questions include questions about drug and alcohol use during pregnancy, which may make the patient uncomfortable. We will also ask questions about stress and anger management as well as the environment in which they live during their most recent pregnancy. All of these questions may make the patient uncomfortable or pose a psychological risk. However, the maternal interview questions have been piloted and patients generally responded very favorably to the questionnaire.

There is no potential risk in obtaining a culture from the placenta. If the patient consents, they will also have an autopsy of their baby, which could be considered a surgical procedure. The risk associated with fetal autopsy would be loss of a fetus or disposal of a fetus not in accordance with the patient¿s wishes. We expect these complications to occur extremely rarely if ever during the study.

Cases:

The patient may recieve no direct benefit form participating in the study.

The direct benefits to you may include the receipt of results of the autopsy and placental exam through your doctor, notification about certain medical conditions through your doctor and a referral for grief support and counseling.