Pregnancy, Labor & Delivery Medication Errors

There are many drugs that are administered to women during pregnancy, labor, and delivery. When appropriate doses are given at the right times, they can be beneficial. Some can help stop preterm labor contractions while others can help induce or speed up labor when necessary.

However, when incorrect doses are given or appropriate dosing procedures are not followed, the results can be devastating and babies can be left with birth injuries, such as hypoxic ischemic encephalopathy (HIE), cerebral palsy, seizure disorders, periventricular leukomalacia (PVL – usually seen in premature babies) and developmental disabilities.

Some of the most common drugs administered during labor and delivery are described below along with the birth injuries that may occur as a result of incorrect use.

Cytotec, also known by its generic name misoprostol, is a drug that is often administered to pregnant women to induce labor.  Cytotec causes uterine contractions and the ripening (effacement or thinning) of the cervix.  Many physicians believe that Cytotec is more effective than Pitocin (also known by its generic name, Oxytocin) when the cervix is not ripe.  In addition to being used alone to induce labor, Cytotec may be used in conjunction with Pitocin.

The use of Cytotec to induce labor is controversial, and many concerns have been raised regarding its safety.  Cytotec is not approved by the Food and Drug Administration (FDA) for use as a labor induction drug.  In fact, as of February, 2013, the FDA’s website states that no company has sent the FDA scientific proof that misoprostol (Cytotec) is safe and effective when used to soften the cervix or induce contractions to begin labor.

Research has shown that Cytotec can have devastating side effects.  The FDA has concluded the following:

“There can be serious side effects, including a torn uterus (womb), when misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births.”

Cytotec is only approved by the FDA for one use: as a treatment for stomach ulcers. When Cytotec was initially on the market, the label stated that the drug should not be used on pregnant women (pregnancy was a contraindication).  In 2000, the manufacturer of Cytotec distributed a letter warning against the use of the drug in pregnant women.  The letter cited the abortifacient (abortion inducing) nature of the drug, as well as the fact that uterine rupture and death had been associated with the use of Cytotec as a labor induction drug.

Indeed, Cytotec can be very harmful to the mother and baby.  It can cause uterine hyperstimulation, which means contractions are very strong, long and frequent.  Hyperstimulation can prevent an adequate supply of oxygen-rich blood from flowing between the baby and the placenta, which can cause severe oxygen deprivation in the baby.

Complications associated with hyperstimulation and Cytotec include the following:

• Uterine rupture
  
• Bradycardia (slow heart rate), tachycardia (fast heart rate), heart rate decelerations
• Cardiac arrhythmia (disruptions in the heart’s normal rhythm)
• Umbilical cord compression
• Birth asphyxia, hypoxic ischemic encephalopathy (oxygen deprivation), brain damage
• Jaundice and kernicterus
• Increased hemorrhaging or blood loss
• Amniotic fluid embolism (amniotic fluid enters the mother’s blood stream, causing a stroke)
• Meconium stained amniotic fluid

Errors can easily occur with Cytotec due to its dosage and method of administration.  Unlike other drugs used for labor induction, such as Pitocin and Cervidil, Cytotec is not administered in IV form or through a removable vaginal insert. Instead, Cytotec is a pill that is inserted vaginally. The pill is typically cut into quarters with one quarter inserted every four hours.  This drug can affect each pregnant woman and baby differently and there is no way to predict how each person will react to Cytotec. If the mother or baby has an adverse reaction to the drug, it cannot be quickly discontinued like other labor induction drugs (e.g., turning off an IV or removing a vaginal insert) since the medication is absorbed into the body.

Furthermore, there can be instances in which Cytotec is doing serious damage to the uterus, but the woman and physician are unaware that something is wrong.  Other times, Cytotec may create immediate, violent contractions.  In fact, ruptures can occur many hours after a single dose in which the drug seemed to have caused no adverse effects.

Women who have had C-sections are at great risk of suffering severe injuries from Cytotec use.  One study reported that 1 in 16 women who had a previous C-section delivery and were administered Cytotec for labor induction suffered a uterine rupture.

Due to the lack of control with Cytotec administration and its potential for devastating complications and injuries, Cytotec should be used in rare instances only.  On the Cytotec label it is explicitly written that this drug is contraindicated for use on pregnant women.  However, if Cytotec is used for labor induction, the medical team must monitor the mother and baby very closely, and the team must be extremely skilled at handling complications and emergencies that can arise as a result of this drug’s use.

Used to induce or speed up labor, Pitocin is a synthetic forms of oxytocin, which is a hormone produced in the woman’s body that promotes contractions of the uterus.  Contractions induced by Pitocin are stronger and last for a longer period of time.

When too much Pitocin is administered, it can cause contractions to occur less than 2-3 minutes apart. This reduces the ability of the placenta to replenish its oxygen supply. When contractions occur too frequently or are too strong (called hyperstimulation), the baby’s brain may not be receiving adequate oxygen, which can cause birth apshyxia, hypoxic ischemic encephalopathy (HIE), cerebral palsy, seizures and other birth injuries.

Hyperstimulation with Pitocin is dangerous because there are no accurate methods to measure the effects it has on the uterus. Additionally, Pitocin is unpredictable.  The effects of any given dose vary widely from excessive and severe contractions and fetal asphyxia to absolutely no recognizable effect on uterine contractility.  Furthermore, the drug starts to work very slowly.  A standard dose doesn’t reach its full potential for about 40 minutes after administration.  Thus, if the medical team administers doses of Pitocin sooner than 40 minutes after the previous dose was given, another dose will have been given without knowing the full effects of the first dose.

Due to its potentially dangerous nature, the Institute for Safe Medication Practices added Pitocin to its list of “high alert medications” in 2009.  In fact, Pitocin is the drug most commonly associated with preventable adverse events during childbirth.

The following are some of the fetal complications associated with Pitocin / Oxytocin use:

• Fetal Distress
• Hypertentsion (increased blood pressure)
• Bradycardia (slow heart rate), tachycardia (fast heart rate), heart rate decelerations
• Cardiac arrhythmia (disruptions in the heart’s normal rhythm)
• Asphyxia, hypoxic ischemic encephalopathy (oxygen deprivation), brain damage
• Fetal acidemia
• Neonatal seizures
• Low Apgar scores
• Retinal hemorrhages (abnormal bleeding of the blood vessels in the eye)
• Fetal head trauma, including brain hemorrhages
• Neonatal jaundice, hyperbilirubinemia

Maternal Injuries and complications associated with Pitocin include the following:

• Strong and prolonged uterine contractions, uterine rupture .  Pitocin is one of the most common causes of uterine rupture.  A recent study found that in one medical center, Pitocin had been administered in 77% of uterine rupture cases.
• Postpartum hemorrhage (greater than normal loss of blood after delivery)
• Subarachnoid hemorrhage (bleeding between the brain and the thin tissue that covers it)
• Tachycardia, bradycardia, premature ventricular contractions and other cardiac arrhythmias
• Hypotension (low blood pressure), hypertension (high blood pressure)
• Anaphylaxis (a life-threatening allergic reaction)
• Pelvic hematoma (accumulation of blood in the soft tissues of the pelvis)

C-section deliveries are relatively safe in the United States. For this reason, and the potential dangers associated with Pitocin, current research does not recommend exceeding established physiologic levels of uterine activity in order to force a vaginal birth.  In fact, it is recommended that Pitocin be used to induce labor only when continuing a pregnancy presents a significant risk to the life of the baby or mother and an unplanned, emergency induction of labor is necessary.  In other words, Pitocin should not be used to selectively induce labor.

Pitocin should not be used in the following situations:

• Substantial cephalopelvic disproportion (CPD)
• Unfavorable fetal position or presentation
• Fetal distress in which delivery is not imminent
• Umbilical cord prolapse
• Hyperactive or hypertonic uterus
• Uterine activity that fails to progress adequately
• Vaginal delivery is contraindicated
• Uterine or surgical scarring

In 2009, the AJOG issued a Clinical Opinion in which it offered the following guidelines:

• Pitocin should be started at relatively low doses
• Fetal monitoring must be utilized
• Contractions are considered acceptable if the contractions have a consistent strength and rate or they have a consistent pattern of 1 strong contraction every 2 – 3 minutes lasting 80 – 90 seconds
• Once acceptable contractions have been met, there should be no additional increases in Pitocin dose
• Pitocin should be aggressively titrated to the lowest dose needed to sustain levels of appropriate uterine activity.
• Delivery by C-section is indicated when acceptable levels of uterine activity have been met at the lowest dose but the labor is not progressing.

Pitocin has long been recognized as dangerous, and researchers have concluded that the health and safety of both the mother and baby may be jeopardized when Pitocin induced hyperstimulation occurs during labor.  Conservative use is necessary and only for non-elective, emergency induction of labor.  Proper fetal monitoring is also necessary.

In almost all situations, physicians are acting negligently when they administer medications in a manner that is against recognized guidelines, contrary to recommendations made in medical research, or if the incorrect dose or medicine is administered.  If the medical team fails to closely monitor a mother and baby, and / or fails to notice signs of distress or medication toxicity, it is negligence.  If this negligence causes injury to a mother or baby, it is medical malpractice.