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Running head: EFFECTS OF INDUCING LABOR WITH CYTOTEC

Effects of Inducing Labor with Cytotec

Jennifer Housel

Ferris State University

ENGL 321

1

EFFECTS OF INDUCING LABOR WITH CYTOTEC2

Abstract

Many patients have their labor induced with Cytotec in the Birth Center at Lapeer McLaren

Region Hospital, but few of them question the risks of the medication. A background of the

ongoing debate regarding the safety of the use of Cytotec in pregnant women is provided. The

research design for this inquiry paper included a questionnaire for birth center nurses and a

literature search. Primary research in this paper includes the surveying of 18 nurses using a

questionnaire interviews with seven nurses. In addition, multiple articles on this topic were

gathered in a literature search to use in comparison to the interviewees’ opinions. Disadvantages

and advantages of inducing labor with Cytotec have been explored. After considering the issue

of Cytotec for the induction of labor, new questions regarding the necessity of induction itself

arouse.


Effects of Inducing Labor with Cytotec

I work as a labor and delivery nurse in the Birth Center at Lapeer McLaren Region

Hospital. Since being hired six months ago, I have induced multiple patients into labor under the

orders of a physician. The way that patients are induced at the Birth Center is with a vaginally

inserted medication called Cytotec. I had never questioned the safety of the medication until I

recently watched the documentary, “More Business of Being Born”. In the film Rikki Lake

interviews Ina May Gaskin on maternal mortality related to the use of Cytotec. Ina May Gaskin,

a leading home-birth midwife and prominent national and international speaker on maternity

care, described the risks of inducing labor with Cytotec. “Maternal deaths must be reviewed to

make motherhood safer” (Gaskin, 2008). This documentary made me interested about the

potential risks of the medication.

It is important for me to know as much as possible about this topic so that I can be

confident in my profession. Part of my responsibility as a nurse is to educate patients on

procedures, medications, and treatments. Therefore, it is also important for the patients that I am

informed about the medications they are receiving. If a patient asks me about the potential

adverse effects of a medication, it is my job to provide them with an unbiased and educated

answer. I have researched the effects of inducing labor with Cytotec.

During my time of employment at the Birth Center, I have used two different types of

medications to induce a patient’s labor. The two medications are Cytotec and Pitocin. Both

medications have received their fair share of negative attention, especially Cytotec. During my

research for this study I was shocked at the extreme amount of negativity towards the medication

Cytotec. This is the medication that I routinely give my patients to induce labor. How could I


have not heard about the potentially deadly side effects before? Surely doctors would not be

ordering medications that were unsafe, would they?

For this paper, the advantages and disadvantages of inducing labor with Cytotec have

been explored. Over a period of five weeks, personal interviews with multiple labor and delivery

nurses in the Birth Center Department at McLaren Lapeer Hospital were conducted. These

interviews were based on a questionnaire made up of seven open-ended questions (see Appendix

A).

The advantages and disadvantages of inducing labor with Cytotec as well as the

precautions that must be taken for patient safety to be ensured will be described in this paper.

Questions regarding the safety of inducing labor could be answered using the information gained

from the surveyed nurses. Providing patient education on medications and procedures is one

possible solution to the public fear of being induced.

Background

Inducing labor is becoming increasingly more popular. Therefore, it is not a surprise that

new and different ways of induction are being used. Some methods of induction are more

natural, while others are based on medical interventions. The trending medication for induction

at the moment is Cytotec. Cytotec is the brand name for the medication, misoprostol. “Cytotec

is synthetic protaglandin E1 analogue that was designed for the prevention and treatment of

peptic ulcer associated with the use of nonsteroidal anti-inflammatory drugs” (Moore, 2002).

While the FDA has approved Cytotec to prevent aspirin-induced gastric ulcers, in obstetrics it is

administered for induction of labor. Around 1990 obstetricians found that Cytotec is also helpful

in inducing labor contractions (Scaer, 2001). The Food and Drug Administration has not


approved this use of the medication. Nevertheless, Cytotec is widely used in the United States

and throughout the world for induction of labor.

The goal of inducing labor is to achieve delivery vaginally by stimulating uterine

contractions before the spontaneous onset of labor. Generally, induction of labor has merit as a

therapeutic option when the benefits of expeditious delivery outweigh the risks of continuing the

pregnancy. The amount of Cytotec used vaginally for induction of labor is different than what is

used orally to treat ulcers. The recommended adult oral dose of Cytotec for ulcer prevention is

800 mcg per day in four divided doses.

At my present place of employment, 25 mcg of Cytotec is used as the initial dose for

cervical ripening and the frequency of administration is never more than every 6 hours. Cervical

ripening is the process of affecting the physical softening and dispensability of the cervix in

preparation for labor and birth. The FDA supports off-label use of approved medications as long

as it is based on sound medical evidence. The American College of Obstetricians and

Gynecologists (ACOG) has a published statement regarding the use of Cytotec for induction of

labor. The physicians that order the medication for induction of labor are following the advice of

ACOG.

ACOG is the nation’s leading group of physicians providing health care for women and

“strongly advocates for quality health care for women, maintains the highest standards of clinical

practice and continuing education of its members, promotes patient education, and increases

awareness among its members and the public of the changing issues facing women’s health care”

(2013). The ACOG Committee on Obstetric Practice reaffirms that Cytotec is a safe and

effective agent for cervical ripening and labor induction when used appropriately [emphasis

added] (Scaer, 2001).


Research Design

In the Birth Center Department a sample of seven registered nurses were questioned

about their experience regarding the effects of inducing labor with Cytotec. The years of nursing

experience ranged from one to 33 years of labor and delivery nursing experience (see Appendix

C, Table C1). Based on a questionnaire that had been previously distributed to them via intra-

department mail, the nurses were individually interviewed. Seven open-ended questions

regarding their professional experience with inducing labor and the medication Cytotec were

asked on the questionnaire (see Appendix A). The nurses all had similar experiences and

opinions regarding medication safety based on the results (see Appendix B). In order to compare

the interviewees’ opinions with those of the general medical profession, a literature search was

conducted.

Primary Research

Using intra-department mail the questionnaires were distributed, and then a personal

interview was conducted on the phone. The survey included an attached memo that described

the rationale for the questionnaire and the purpose of the research study; the questionnaire was

attached to the memo. The 7 interviewed nurses agreed to respond truthfully and expressed their

interest in contributing. Nurses in the Birth Center Department have had similar experiences as

far as inducing labor is concerned, according to the results. All 18 nurses surveyed have used

Cytotec countless times on patients under the orders of a physician.

Literature Search

Using the database CINAHAL, a literature search exploring perceived or real risks

existing for patients being induced with Cytotec was conducted. The key words Cytotec,

misoprostol, pregnancy, labor, induction, drug effects, tachysystole, and uterine rupture were


used. The articles selected were empirically based and examined perception of medication safety

in addition to being peer-reviewed. From published and credible sources, five relevant and

useful articles were found. Since Cytotec remains unapproved by the FDA for induction of

labor, the search did not exclude older articles in favor of more current articles. Furthermore,

medication safety remains a consistent theme in nursing practice.

Observations and Analysis

The present safety in inducing labor with Cytotec is documented in the primary research

findings. Jennifer Dohm discloses, “When I induce a patient, I follow hospital and department

protocol for monitoring the patient’s uterine contractions and the baby’s heart rate” (personal

communication, October 19, 2013). The statement provides insight into the nurses’ compliance

with monitoring guidelines for induction patients. Barbra Wager emphasized the importance of

reporting contraction patterns in a timely manner to the physician (personal communication,

November 9, 2011).

From the literature review similar results were yielded. Various ways that a patient is

monitored before and during induction of labor have been described. The patient’s uterine

contractions are monitored either externally with a Tocodynamometer (TOCO) or internally with

an Intrauterine Pressure Catheter (IUPC). The importance of following the guidelines and

protocols set by the Association of Women’s Health, Obstetric and Neonatal Nurses

(AWHONN) by closely monitoring the force of uterine contractions was reiterated in the Journal

of Obstetric, Gynecologic, and Neonatal Nursing (JOGNN), in a published research article

(Teplick, 2012).


Disadvantages

Every medication has side effects when the labels are read. For example, just read the

terrifying list of potential adverse effects on the side of a bottle of generic Tylenol. Serious

complications such as liver failure can be found. When the black box warming is read from the

Cytotec medication label, serious complications such as uterine rupture are listed.

“Disadvantages are uterine hyperstimulation and, in rare instances, uterine rupture and death”

(Moore, 2002). The terms hyperstimulation and hypercontractility are currently no longer used.

During her interview, Luanne Pearsall notes “it is recommended that the term tachysystole, with

or without corresponding FHR decelerations, be used instead” (personal communication,

December 1, 2013). Tachysystole is defined as more than five contractions in 10 minutes,

averaged over a 30-minute window.

Multiple cases of uterine tachysystole with corresponding FHR decelerations have been

documented. Mahlmeister commented on the legal risk involved with such adverse events:

However, the administration of prostaglandin cervical ripeners is not without risk.

Researchers have reported uterine hyperstimulation requiring tocolysis, non-reassuring

fetal heart rate (FHR) patterns, and in rare instances, serious complications, including

precipitate labor and delivery, fetal hypoxia, and even uterine rupture in women without

uterine scars. When negative outcomes occur with the use of prostaglandin ripening

agents, litigation often ensues (2005).

The real trouble is not in the court cases, but in the lives affected. In 2010, an article on labor

and delivery about a child diagnosed with cerebral palsy was published in the Legal Eagle Eye

Newsletter for the Nursing Profession. The newsletter reported that the child’s injuries were a

result of reduced oxygen due to contractions that were rapid and prolonged during the last hours


of his mother’s labor. The labor and delivery nurses were blamed for the child’s injuries since

they failed to report the uterine tachysystole to the physician (p. 7).

Advantages

While the disadvantages for using Cytotec to induce labor are scary, the advantages must

also be considered. The nurses believe, and the literature corresponds, that Cytotec has

significantly improved the rate of successful induction. Due this improved rate of successful

inductions, Cytotec has also been shown to reduce the incidence of cesarean sections associated

with failed induction attempts (Mahlmeister, 2005). Sandra Johnson cited a belief that women

experience “shorter duration of labor” when induced using Cytotec (personal communication,

November 9, 2011).

Many people have shared their distress and anxiety over the use of medicine to induce

labor, and some have even voiced their opinion that the FDA should ban the use of Cytotec in

pregnancy. Others have contradicted this view:

The use of Cytotec to induce labor is not part of some conspiracy. Like any medication,

including oxytocin, it has a risk of complications, such as uterine hyperstimulation.

Uterine rupture of the unscarred uterus has been reported with the use of Cytotec, but has

also occurred in unaugmented labor. In my practice I have found Cytotec valuable to

reduce the likelihood of cesarean delivery. When I have to induce labor for a medical

complication such as hypertension, I have found that with the use of Cytotec I can

provide a good chance of a successful induction and vaginal delivery for a woman who,

in the past, would have been thought to have an unfavorable cervix unamenable to

induction. Of course any medication is dangerous when misused (Devitt & Goer, 2003).


New Questions

Currently, many obstetricians frequently use Cytotec to induce labor and have had great

success doing so. Why is it necessary for so many patients to be induced? The induction rate in

the United States is increasing at an alarming rate. Mary Lou Moore inquired on this topic:

Occasions occur when medical induction is appropriate. However, some inductions are

associated with issues of convenience, either for a physician or for a mother and her

family. If an induction is considered, it is appropriate for the mother to discuss with her

physician the risks and benefits both of the induction and of the medication and dosage

that will be used (2002).

Mary Lou Moore made me think of a few other questions. Since inductions are not emergency

procedures, why are informed consents not required before the use of Cytotec? “Women should

be given should information about what is known and not known regarding methods of induction

in order to be able to participate fully in making decisions about induction of labor”

(Mozurkewich et al., 2011).

In conclusion, the best available evidence should be used when choosing methods of

labor induction. This study, along with the literature, shows that there can be real risks, as well

as benefits when using Cytotec to induce labor. Many women have been successfully induced

with Cytotec in spite of the risks. Accurate nursing assessments of mother and child increase the

overall safety of induction. Obstetricians must follow ACOG’s guidelines on conservative initial

dosing, and much can be done to educate patients on medication and dosage. Additionally,

nurses can reinforce this patient education in a childbirth education class. It is in this way that

nurses can provide information before patients consent to risky procedures.


References

American Congress of Obstetricians and Gynecologists. (2013). Who we are. Retrieved from

http://www.acog.org/About_ACOG/Who_We_Are

Devitt, N., & Goer, H. (2003). Cytotec (misoprostol). Goer H. In the literature: "Spin doctoring"

the research. Birth 2003;30:124-9. Birth: Issues In Perinatal Care, 30(4), 285. Retrieved

from CINAHL Plus with Full Text.

Gaskin, I. M. (2008). Maternal death in the United States: A problem solved or a problem

ignored? The Journal of Perinatal Education, 17(2), 9-13. Retrieved from CINAHL Plus

with Full Text.

Labor & delivery: nurses failed to report uterine hyperstimulation. (2010). Legal Eagle Eye

Newsletter for the Nursing Profession, 18(5), 7. Retrieved from CINAHL Plus with Full

Text.

Moore, M. (2002). Research update. Misoprostol -- is more research needed?. Journal Of

Perinatal Education, 11(3), 43-47. Retrieved from CINAHL Plus with Full Text.

Mozurkewich, E., Chilimigras, J., Berman, D., Perni, U., Romero, V., King, V., & Keeton, K.

(2011). Methods of induction of labour: a systematic review. BMC Pregnancy &

Childbirth, 1184. Retrieved from CINAHL Plus with Full Text.

Scaer, R. (2001). Misoprostol (Cytotec, Searle) induction controversy. Genesis, 3. Retrieved

from CINAHL Plus with Full Text.

Teplick, F. (2012). Assessment of an Alternative Stablization Device for Electronic Fetal

Monitoring Utilizing External Ultrasound and Tocodynamometer in Labor and Delivery

Patients. JOGNN: Journal of Obstetric, Gynecologic & Neonatal Nursing, 41S140.

doi:10:1111/j.1552-6909.2012.01362

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