Thursday, December 17, 2015

The Evidence Says: Update on the Use of Cytotec

This is the first in a series of research update articles, titled "The Evidence Says".

The drug Misoprostol (marketed as Cytotec) has been shown to be effective in inducing labor, and some studies have shown that the vaginal use of misoprostol results in fewer cesarean sections than oxytocin.  This being said, there are still not enough data to determine the best dose to ensure safety.

According to the most current information from the  FDA (US Food and Drug Administration),
This Patient Information Sheet is for pregnant women who may receive misoprostol to soften
their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. These uses are not approved by the FDA. No company has sent the FDA scientific proof that misoprostol is safe and effective for these uses.
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.
Given in the oral or buccal dose, it is confusing why this method of dosing is allowed to continue.  Previously, Pitocin was available in a buccal dose and this type of dosing was discontinued due to a history of reported erratic and uncontrollable absorption rates which resulted in frequent and intense contractions, uterine hypercontractility, uterine ruptures, excessive increase in muscle tension that caused babies to suffer hypoxia.  Legal history shows multiple settlements from both hospitals and obstetricians paying.  It is therefore confusing and disturbing that oral or buccal Misoprostol.
The World Health Organization notes 38 trials with 7022 participants comparing vaginal misoprostol and vaginal prostaglandins (dinoprostone).  The results were more common occurrence of uterine stimulation with fetal heart rate changes and meconium-stained amniotic fluid with misoprostol.  Rates of cesarean varied.
One of the primary reasons to use misoprostol over Pitocin is cost.  When used as a cervical ripening agent or induction of labor agent, misoprostol is a low-cost intervention.  However, misoprostol is not FDA approved for use during pregnancy as a labor induction agent.  Further, the “recommended dose” of 25 ug is not widely available for oral use.
In their book, Optimal Care in Childbirth: the Case for a Physiologic Approach (2012), Amy Romano and Henci Goer explore the use of misoprostol, Pitocin and mechanical induction methods.  I highly recommend this book for any birth professional.
The controversy continues in regards to both the use of misoprostol and induction of labor.  Best practice is defined as treatment and care that takes into account a woman’s individual needs and preferences.  In accordance with birth organizations such as the International Childbirth Education Association motto, freedom to make decisions based on knowledge of alternatives in family-centered maternity and newborn care, health care professionals should give women the opportunity to make informed decisions about their care.  The AHRQ (2015) cautions against labor induction as it has been associated with a twofold increase in the odds of cesarean section.  They go on to state that “Beyond the medical burden to mothers and babies, the financial burden on payers is labor: facility charges for cesareans are nearly twice that for vaginal delivery ($24,700 vs $14,500).  The AHRQ previously went on the record in 2009 as favoring elective inductions.
Opportunities should be available to evaluate each situation based on Bishop Score, fetal well-being and informed decision-making of the expectant parents.  In an informed decision-making scenario, both the risks and benefits of any medication, including Misoprostol should be examined and reported.  Since Misoprostol brings with it a myriad of risks for all types of women (nulliparous, multiparous, vbac, etc), it is counterintuitive as to why the medical profession would choose a drug that leads to increased liability.
It would appear that the bottom line is that modern obstetrics still clings to the “active management of labor”, in spite of the fact that induction for postdates is no longer valid, elective induction is no longer valid, and induction for macrosomia is no longer valid. All care providers must strive for optimal safety of the mother and fetus. And in this author’s humble opinion, the use of a drug that has a package insert:  side effects of “hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism.  Pelvic pain, retained placenta, several genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported” is not striving for optimal safety of the mother and fetus.  Rather, it is the promotion of an assembly-line child delivery system, ignoring the sacred miracle of the birthing process.

Resources for this article:
International Childbirth Education Association

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