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 www.icea.org
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