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In a prospective, randomized study, magnesium sulfate was superior to phenytoin

for the prevention of eclampsia in hypertensive pregnant women.

109

In addition,

magnesium sulfate was more effective than nimodipine for seizure prophylaxis in

severely preeclamptic women.

112,113

A regimen of magnesium sulfate 4 to 6 g IV as a loading dose followed by a

continuous infusion of 2 g/hour is the most commonly used regimen in the United

States.

115 Lower dosages (e.g., 1 g/hour) have been associated with treatment

failures.

116

IV loading doses of 6 g followed by continuous infusions of 2 g/hour

maintain therapeutically effective magnesium serum concentrations between 4 and 8

mg/dL.

115 Because magnesium is excreted by the kidneys and will accumulate in

cases of renal dysfunction, the continuous infusion rate must be lowered with oliguria

or an elevated SCr.

Because of the potential for infusion errors and significant patient morbidity and

even mortality with accidental overdoses of magnesium sulfate, the Institute of

Medicine has identified magnesium sulfate as a high-risk medication.

116 All infusions

of magnesium sulfate must be given through a controlled pump designed to protect

against free flow. If such an infusion pump is not available, the intramuscular (IM)

route of administration should be used. Dispensing premixed IV bags from the central

pharmacy with a standardized concentration of magnesium sulfate and limiting the

total grams of magnesium sulfate in each dispensed IV bag also can help guard

against inadvertent overdose. Dispensing the loading dose in a separate small bag

(e.g., 4 g in 100 mL) from the maintenance bag (e.g., 20 g in 200 mL) also may be

helpful.

117

Magnesium sulfate should be given to T.D. to prevent eclamptic seizures during

labor.

80 T.D. should be loaded with magnesium sulfate 4 g IV given for 30 minutes

and then started on a continuous infusion of 2 g/hour.

MONITORING MAGNESIUM SULFATE THERAPY

CASE 49-5, QUESTION 11: T.D. has been given magnesium sulfate 4 g IV for 30 minutes and was then

started on a continuous infusion of 2 g/hour. What subjective and objective data should be monitored during

treatment of T.D. with magnesium?

Deep tendon reflexes (patellar reflex), respiratory rate, and urine output should be

monitored periodically during treatment with magnesium sulfate.

109 The loss of

patellar reflexes, the first sign of magnesium toxicity, generally occurs at serum

concentrations of

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8 to 12 mg/dL. The respiratory rate should be monitored hourly and should be

greater than 12 breaths/minute. Respiratory arrest can occur with serum

concentrations of greater than 13 mg/dL. Urine output should be carefully monitored

and should be at least 100 mL every 4 hours (or 25 mL/hour).

109 Magnesium serum

concentrations are not routinely measured unless renal dysfunction is evident with

oliguria or elevated SCr because magnesium is almost entirely excreted by the

kidney.

106,109 Hypocalcemia and hypocalcemic tetany also can occur secondary to

elevated magnesium and can be reversed by calcium gluconate 1 g (10 mL of a 10%

solution) slow IV push for 3 minutes. Neuromuscular depression can occur in infants

whose mothers received magnesium sulfate.

38 Parenteral magnesium sulfate is safe

and rarely causes maternal or neonatal toxicity when administered properly but

requires stringent, built-in system safeguards to avoid unintended dosing errors.

117

CASE 49-5, QUESTION 12: How long should magnesium sulfate be continued in T.D.?

Depending on the severity of preeclampsia, magnesium sulfate therapy usually is

continued for 24 hours after delivery, which should be the same for T.D.

118 Women

with severe preeclampsia or preeclampsia superimposed on chronic hypertension are

at greater risk for disease exacerbation when magnesium sulfate is discontinued too

soon.

TREATMENT OF ECLAMPSIA

CASE 49-5, QUESTION 13: T.D. delivers vaginally and her magnesium infusion was discontinued by

mistake 3 hours postpartum. T.D. experiences an eclamptic seizure 4 hours later when her nurses discover that

the magnesium is disconnected. What is appropriate drug therapy for eclampsia?

Lorazepam, diazepam, phenytoin, and magnesium sulfate have all been used to

treat eclampsia. The use of magnesium sulfate to treat these seizures results in less

maternal morbidity and mortality and less neonatal morbidity.

109,119 Generally, higher

serum concentrations of magnesium sulfate are needed to treat than to prevent

eclamptic seizures. The same therapeutic range guides both prophylaxis and

treatment, however.

114 Seizures unresponsive to magnesium sulfate treatment should

prompt an evaluation for other cerebrovascular events (e.g., cerebral hemorrhage or

infarction).

115 Lorazepam 2 to 4 mg slow IV push stat should be given for seizure

cessation. T.D. should be reloaded with magnesium sulfate and continued on a

magnesium infusion for 24 to 48 hours.

DRUG THERAPY MANAGEMENT IN LABOR AND

DELIVERY

Induction of Labor

MECHANISMS OF TERM LABOR

In pregnancy, many hormones and peptides, including progesterone, prostacyclin,

relaxin, nitric oxide, and parathyroid hormone-related peptide, inhibit uterine smooth

muscle contractility. Labor at term occurs because the myometrium is released from

its quiescent state.

120 For example, as progesterone concentrations decrease near term

gestation, estrogen may stimulate uterine contractility.

Uterine activity is divided into four phases: quiescence (phase 0), activation

(phase 1), stimulation (phase 2), and involution (phase 3). Each of these phases is

stimulated or inhibited by several factors.

120 During activation, uterotropins such as

estrogen, and possibly others, stimulate a complex series of uterine changes (e.g.,

increased myometrial prostaglandin and oxytocin receptors and myometrial gap

junctions), which are important for the coordination of contractions. These changes

help prime the myometrium and cervix for stimulation by the uterotonins oxytocin and

prostaglandins E2 and F2α. The cervix softens, shortens, and dilates, a process

referred to as cervical ripening. Uterine stimulation is responsible for the change in

myometrial activity from irregular to regular contractions. During phase 3, involution

of the uterus occurs after delivery and is mediated mostly by oxytocin.

120

The exact stimulus of the biochemical scheme leading to labor in humans is

unknown. The fetus may help facilitate this process by affecting placental steroid

production through mechanical distension of the uterus and by activating the fetal

hypothalamic–pituitary–adrenal axis. Ultimately, these lead to increased production

of oxytocin and prostaglandins by the fetoplacental unit.

Labor is divided into three stages. Weak, irregular, rhythmic contractions

(Braxton-Hicks contractions or “false labor”) may happen for weeks before the onset

of true labor. The first stage begins with the start of regular uterine contractions and

ends with complete cervical dilation. Stage 1 is divided further into the latent phase,

active phase, and deceleration phase. During the latent phase, the cervix effaces

(thins) but dilates minimally. The contractions become progressively stronger and

longer, better coordinated, and more frequent. The duration of the latent phase is the

most varied and unpredictable of all aspects of labor, and can continue intermittently

for days. During the active phase, contractions are strong and regular, occurring

every 2 to 3 minutes. The cervix dilates from 3 to 4 cm to full dilation, usually 10 cm.

The second stage starts with complete cervical dilation and ends with the delivery of

the fetus. The third stage of labor is the time between the delivery of the fetus and the

delivery of the placenta.

INDICATIONS, CONTRAINDICATIONS, AND REQUIREMENTS

CASE 49-6

QUESTION 1: J.T., a 28-year-old primigravida, is admitted to the labor and delivery suite for labor induction.

She is at 42 weeks’ gestation by dates and ultrasound and has a normal obstetric examination. Cervical

examination reveals an unfavorable cervix for labor induction; Bishop score is 4. What are the indications and

contraindications for labor induction in J.T.?

The induction of labor involves the artificial stimulation of uterine contractions

that lead to labor and delivery. Induction of labor is indicated when the benefits to

either the mother or fetus outweigh those of continuing the pregnancy. Examples may

include preeclampsia, chorioamnionitis (infection of the fetal membranes, see Case

49-7, Question 11), fetal demise, significant fetal growth restriction, maternal

medical problems, and post-term pregnancy.

121 Post-term pregnancy (≥42 weeks’

gestation), as in J.T.’s case, is one of the most common indications for induction of

labor.

121 Contraindications to labor induction are similar to those for spontaneous

labor and vaginal delivery and include, but are not limited to, active genital herpes

infection, placenta previa (placenta implanted over the internal cervical opening),

prior classic uterine incision, transverse fetal lie (laying longitudinally across the

uterus), and prolapsed umbilical cord. Maternal complications that are associated

with induction include increased rates of chorioamnionitis and uterine atony (loss of

tone in uterine musculature) (see Case 49-8, Question 4) resulting in hemorrhage, as

well as a twofold to threefold increased risk of cesarean delivery, particularly in

primigravida women.

122

A complete assessment of both mother and fetus should be performed before

inducing labor.

121,123 Gestational age must be

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assessed accurately before the induction of labor to avoid the inadvertent delivery

of a preterm fetus.

121,122 When delivery is necessary before 34 weeks’ gestation with

intact membranes or before 32 weeks’ gestation with ruptured membranes, antenatal

corticosteroids should be administered (see Case 49-7, Question 7).

123,124

The degree of cervical ripeness and readiness for induction of labor should be

assessed.

121,125 Success of labor induction is directly related to the favorability of the

cervix.

126,127 The Bishop method of evaluating cervical ripeness assigns a score

based on the station of the fetal head relative to the maternal ischial spines and the

extent of cervical dilation, effacement (thinning of the cervix), consistency, and

position.

122,125 Bishop scores of greater than 8 are associated with rates of vaginal

delivery similar to those after spontaneous labor.

121 Conversely, Bishop scores of 4

or less, as documented in J.T., are associated with a high likelihood of failed

induction and cesarean delivery. As a result, significant research has been directed

toward methods of improving the Bishop score and cervix ripeness before

stimulation of uterine contractions. However, women with low Bishop scores who

undergo cervical ripening before induction of labor still have higher rates of

cesarean delivery compared with spontaneous labor.

126 Nevertheless, cervical

ripening appears to have some benefit in decreasing time to delivery, shortening

labor, and successfully improving Bishop score.

121

Cervical ripening can be accomplished pharmacologically or mechanically.

Pharmacologic methods include the administration of prostaglandins (E2 and E1

) or

low-dose oxytocin. Mechanical methods include membrane sweeping (or membrane

stripping), and intracervical balloons.

121,123,125 Osmotic or hygroscopic dilators (e.g.,

Dilapan, Lamicel) work by absorbing cervical mucus and gradually swelling, thereby

dilating the cervical canal.

122,125

In the setting of a favorable Bishop score, labor

induction is accomplished most commonly by amniotomy (artificial rupture of the

fetal membranes) and oxytocin administration.

121,122

Although labor induction is medically indicated in J.T. to decrease the risk of an

adverse fetal outcome with continuing a post-term pregnancy, such as macrosomia,

asphyxia, meconium aspiration, and intrauterine infection, her cervix is unfavorable

for induction and she is a candidate for cervix ripening.

CERVICAL RIPENING

CASE 49-6, QUESTION 2: What pharmacologic agents can be used for cervical ripening in J.T.?

Misoprostol (Cytotec)

Prostaglandins induce cervical ripening and enhance myometrial sensitivity to

oxytocin by promoting the breakdown of collagen and increasing the submucosal

hyaluronic acid and water content.

121,122,125 Misoprostol is a prostaglandin E1 analog

approved for use in the prevention of nonsteroidal anti-inflammatory drug-induced

peptic ulcer disease. It also has been used for cervical ripening and the induction of

labor in women despite the lack of approval by the FDA for these latter

indications.

128,129

In two large meta-analyses, misoprostol was more effective for

cervical ripening and labor induction than either placebo or treatment with

dinoprostone (prostaglandin E2

).

128,129

In comparisons, intravaginal misoprostol

produced labor more often during cervical ripening and resulted in reduced rate of

cesarean deliveries, shorter delivery times, and a greater incidence of vaginal

delivery within 24 hours but had a higher incidence of uterine contraction

abnormalities than either dinoprostone vaginal insert or dinoprostone endocervical

gel.

128–132 Uterine tachysystole, excessively frequent uterine contractions, without

fetal heart rate abnormalities was more common with misoprostol use. Maternal and

neonatal outcomes were similar in both groups. The need for oxytocin is decreased

significantly in women treated with misoprostol compared with women treated with

dinoprostone.

131

Oral misoprostol has also been studied for cervical ripening, but comparisons of

vaginal and oral misoprostol are complicated by wide variations in dose and dose

interval.

132 A meta-analysis of available studies concluded that the only consistent

finding was a reduction in low 5-minute Apgar scores with oral misoprostol but no

difference in neonatal intensive care unit admissions. When comparing all studies

with a wide range of doses, oral misoprostol resulted in similar rates of vaginal

delivery not achieved in 24 hours, uterine tachysystole with fetal heart rate changes,

and cesarean delivery compared with vaginal misoprostol.

122

Misoprostol 25 mcg (one-fourth of an unscored 100-mcg tablet) is inserted into the

posterior vaginal fornix and repeated as needed every 3 to 6 hours.

130,131 Higher

doses of 50 mcg are associated with increased uterine contractile abnormalities.

128,132

Continuous fetal heart rate and uterine monitoring is recommended throughout the

administration of misoprostol.

133

If oxytocin is indicated after cervical ripening,

administration should be delayed at least 4 hours from the last dose of misoprostol.

121

Misoprostol should not be used in women with previous uterine scars because of

the risk for uterine rupture.

121,130,132 Although misoprostol is a known teratogen in the

first trimester of pregnancy, particularly if used in an unsuccessful attempt at medical

abortion, there are no such reports with exposure beyond the first trimester.

38,130

Misoprostol’s low cost and ease of administration are advantages compared with

dinoprostone, and there is extensive clinical experience with this agent; however, its

lack of FDA approval for cervical ripening and induction of labor is a disadvantage.

Clinical trials of a controlled-release misoprostol vaginal insert are currently

ongoing.

133

Prostaglandin E

2

(Dinoprostone)

There are two FDA-approved forms of dinoprostone available for cervical ripening.

Up to half of the women treated with dinoprostone experience labor and deliver

within 24 hours, some without oxytocin.

134,136 Dinoprostone cervical gel (Prepidil

Gel) contains dinoprostone contains 0.5 mg per 3-g syringe (2.5 mL gel) and is

administered endocervically. The dinoprostone cervical gel must be refrigerated, and

dinoprostone vaginal inserts must remain frozen until administration. Dinoprostone

slow-release insert (Cervidil) contains dinoprostone 10 mg and is inserted

vaginally.

137 Post-term women with unfavorable cervices who receive dinoprostone

have shorter durations of labor, and require lower doses of oxytocin, compared with

placebo or no therapy.

125,134–136 A large meta-analysis that included more than 10,000

women found that the use of vaginal prostaglandin E2 compared with no treatment or

placebo was associated with increased rates of vaginal delivery within 24 hours,

increased rates of cervix ripening, reduced need for oxytocin augmentation, and no

difference in cesarean section. The risk of uterine tachysystole with fetal heart rate

changes was increased, however.

138

Both dinoprostone products are effective for cervical ripening, leading to

successful induction of labor.

125,134–136 The two dinoprostone formulations differ in

dosing and application.

139,141 The dinoprostone 10-mg vaginal insert slowly releases

dinoprostone 0.3 mg/hour for a 12-hour period.

137 The insert is contained within a

knitted pouch attached to a long tape. Advantages of the vaginal insert include that it

is easier for the clinician to place and less uncomfortable for the patient. In addition,

the insert can be removed with the onset of active labor or the development of uterine

tachysystole with concurrent fetal heart rate tracing abnormalities. It should be

removed within 12 hours of placement or after active labor develops, the membranes

rupture, or there is evidence of tachysystole with fetal heart rate changes.

141

If

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dinoprostone cervical gel is used, the dose can be repeated in 6 to 12 hours if

there is inadequate change in the cervix and only minimal uterine activity, but no

more than three total doses are recommended.

141 The manufacturer of Prepidil

recommends a delay in initiation of oxytocin of 6 to 12 hours once the gel has been

placed compared with a shorter delay of only 30 to 60 minutes after the vaginal insert

has been removed. An initial period of uterine and fetal monitoring of up to 2 hours

should occur after placement of the intracervical gel, with continued monitoring

thereafter if regular uterine contractions develop and persist.

121

The most serious side effect associated with dinoprostone administration is uterine

hyperstimulation with or without an abnormal fetal heart rate tracing. The incidence

of uterine hyperstimulation associated with the use of dinoprostone intravaginal

insert is about 5%; the rate of occurrence for dinoprostone endocervical gel is about

1%.

121 Uterine hyperstimulation occurs more frequently if the Bishop score is greater

than 4 before administration of dinoprostone and can occur up to 9.5 hours after

placement of the intravaginal insert.

121,141 Use of the vaginal insert requires

continuous monitoring of fetal heart rate and uterine activity for as long as the insert

is in place and for at least 15 minutes after its removal because of possible uterine

hyperstimulation anytime during its administration.

135 Most episodes of uterine

hyperstimulation with the use of the vaginal insert occur during active labor and

resolve within a few minutes after removal of the insert.

136 Uterine contraction

abnormalities may be avoided if the insert is promptly removed at the onset of

labor.

128 Both dinoprostone formulations are associated with fever, nausea, vomiting,

and diarrhea, and neither are associated with adverse neonatal outcomes.

121,137,139

For J.T., misoprostol 25 mcg should be administered intravaginally every 3 to 6

hours for cervical ripening. Misoprostol is the most cost-effective option for cervical

ripening.

OXYTOCIN

Mechanism of Action

CASE 49-6, QUESTION 3: Twelve hours after administration of two 25-mcg doses of misoprostol, J.T.’s

cervix has responded and her Bishop score is now 9, but she has not developed a consistent pattern of uterine

contractions. What drug therapy should be initiated at this point?

Synthetic oxytocin should be administered to J.T. to stimulate uterine contractions

for accomplishing delivery. Oxytocin increases the frequency, force, and duration of

uterine contractions.

142 The uterine response to oxytocin increases throughout

pregnancy beginning at approximately 20 weeks’ gestation and increases

considerably at 30 weeks’ gestation.

140 Oxytocin is indicated for both the induction

and augmentation of labor. A prolonged latent phase or dystocia (difficult labor)

caused by uterine hypocontractility in the active phase of labor is the indication for

augmentation with oxytocin.

140

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