Yes. It is common for physicians to use high alert and off-label medications to induce or speed up labor. Sometimes the use of these drugs results in catastrophic consequences for the baby. Physicians must follow standards of care, and they have a duty to their patients. Hospitals also have a duty to ensure patient safety and prevent foreseeable injuries.
Induction Drugs Are Commonly Used but Potentially Dangerous
Utilization of medications to start and speed up labor is a very common obstetrical practice. Many birth injuries – damage that occurs to babies during labor and delivery – occur because physicians misuse these risky drugs. In addition, the nursing staff and physicians often fail to properly monitor the mother and baby and/or perform timely and critical interventions when the mother’s contractions become excessive and the baby’s heart rate becomes abnormal, or nonreassuring. Birth injuries that can occur when labor drugs are used include cerebral palsy, hypoxic-ischemic encephalopathy (HIE), brain bleeds, and intellectual and developmental disabilities.
Uterine Tachysystole and Resulting Hyperstimulation Can Cause Oxygen Deprivation in the Baby
The use of labor drugs to ripen the cervix or induce or augment labor can lead to uterine tachysystole (sometimes called hyperstimulation or hypertonus). This refers to contractions that are too strong, too frequent, and too long. Physicians and the medical team cannot safely manage patients in labor without a proper understanding of uterine activity and its effect on the baby’s oxygen level and heart rate. The potential harm can be very serious.
There are many vessels in the womb that carry blood from the mother to the placenta, and through the umbilical cord to the baby. When a contraction occurs, these vessels are pushed on or impinged upon, which decreases or stops the blood flow going to the baby. When the contraction stops, blood can flow again and the placenta is recharged with oxygen-rich blood for the baby.
If there is uterine tachysystole, the placenta does not have enough time to recharge with a fresh supply of oxygen-rich blood for the baby. This can cause the baby’s oxygen levels to get progressively worse, with the worst result being complete oxygen deprivation (asphyxia), which can cause permanent brain damage in the baby. In addition, the baby’s blood can become very acidic (a state called acidosis/acidemia) when oxygen deprivation is prolonged, which also causes cellular damage to the brain and body.
Since tachysystole can have devastating consequences for the baby, it is crucial that the medical team make every effort to avoid it. In addition, tachysystole must be recognized as soon as it starts to occur, and it must be quickly and appropriately treated. It also is critical that the team have the utmost skill in interpreting the baby’s heart rate on the fetal monitor. Waiting until the baby’s heart rate is indeterminate or abnormal to treat tachysystole is dangerous and negligent.
Labor Induction Drugs: Pitocin and Cytotec
The Food and Drug Administration (FDA) has approved oxytocin (Pitocin) and dinoprostone for ripening (softening) the cervix and inducing labor. However, the FDA approved misoprostol (Cytotec) only to treat stomach ulcers, but physicians often use it ‘off-label’ to ripen the cervix and induce labor. Until 2002, the FDA listed labor induction and cervical ripening as contraindications to Cytotec use. In 2002, these contraindications were removed, but the FDA continues to warn physicians that using the drug can lead to adverse outcomes, including tachysystole, uterine rupture, and amniotic fluid embolism (wherein amniotic fluid or debris enters the mother’s blood stream and triggers a severe allergic reaction). All of these outcomes can lead to severe oxygen deprivation in the baby, HIE, and cerebral palsy.
The American Congress of Obstetricians and Gynecologists (ACOG) agrees with experts who find that use of Cytotec for labor induction is dangerous in women who have a previous C-section scar (VBAC) or have had major uterine surgery. Cytotec is contraindicated in these instances because it puts the mother at great risk for uterine rupture.
ACOG’s position is that small doses of Cytotec may be used every 3 – 6 hours. Research shows that when too much is used (50 mcg or more in a six hour period), there is an increased risk of complications, including uterine tachysystole and abnormal fetal heart rates.
One study examined the incidence and timing of excessive uterine activity during Cytotec use. The study found that even low doses of Cytotec were associated with excessive uterine activity and indeterminate or abnormal heart rates in babies, compared to women who had spontaneous labor and those whose labor was induced with oxytocin and dinoprostone.
Oxytocin (Pitocin) is the most common drug used to induce or augment labor in the U.S. In 2007, it was listed as a “high-alert” medication by the Institute for Safe Medication Practices. This means the drug carries a high risk of harm when improperly used and requires special safeguards to reduce the risk of error. Research shows that oxytocin increases the risk of excessive uterine activity and impairs blood flow to the baby from the placenta. It is a cause of birth asphyxia during labor.
Researcher Kathleen Rice Simpson has explained that “the leading cause of obstetric liability claims and payout … is oxytocin administration leading to hyperstimulation with subsequent fetal injury (hypoxia/acidosis/asphyxia).” Simpson determined that the best way to ensure safety of the mother and baby “is to implement one unit policy or protocol that everyone is expected to follow, one that outlines (in detail) the initial dosage, intervals, dosage for increases in rate, and interventions for excessive uterine activity (hyperstimulation) with or without a nonreassuring fetal heart rate (FHR) pattern.”
According to ACOG, uterine tachysystole and abnormal fetal heart tracings are common when oxytocin is used. Low-dose oxytocin regimens are less likely to cause these problems. ACOG recommends that every obstetrics department develop guidelines for the preparation and administration of oxytocin by staff members who are familiar with its adverse effects and who have skill in fetal heart rate and contraction monitoring. It is emphasized by ACOG that when oxytocin is used, every effort must be made to reduce uterine activity to minimize the risk of oxygen deprivation and acidemia in the baby.
ACOG recommends that oxytocin be reduced when tachysystole occurs in the presence of mildly abnormal fetal heart tracings, called category I tracings, and that oxytocin be stopped when tachysystole occurs along with severe fetal heart tracings, called category II or III tracings. However, most experts do not think this guideline is strict enough, and most emphasize that waiting until a heart rate tracing is abnormal to stop oxytocin and treat tachysystole is not consistent with fetal safety.
Trusted Detroit, Michigan Birth Injury Attorneys
Legal Help for Pitocin and Cytotec Injuries
If your labor was induced using Pitocin or Cytotec and your child has been diagnosed with a permanent disability, call the birth injury attorneys at Reiter & Walsh ABC Law Centers. We have helped children throughout the country obtain compensation for lifelong treatment, therapy, and a secure future, and we give personal attention to each child and family we represent. Our firm has numerous multi-million dollar verdicts and settlements that attest to our success, and no fees are ever paid to our firm until we win your case. Email or call Reiter & Walsh ABC Law Centers at 888-419-2229 for a free case evaluation. Our award-winning lawyers are available 24 / 7 to speak with you.
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- Cytotec Injuries
- Cytotec and the FDA
- Medication Errors: Detailed Overview
- Research: Induction Medication and the NICU
- Pitocin: Common but Dangerous
Video: Pitocin and Birth Asphyxia
Watch a video of birth injury lawyers Jesse Reiter and Rebecca Walsh discussing birth asphyxia and its causes, which include mismanagement of Pitocin during labor and delivery.