GUIDELINE
ASGE Guideline:guidelines for endoscopy in pregnant and lactating women
This is one of a ries of statements discussing the utilization of GI endoscopy in common clinical situa-tions.The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy pre-pared this text.In preparing this guideline,a MEDLINE literature arch was performed and additional refer-ences were obtained from the bibliographies of the identified articles and from recommendations of expert consultants.When little or no data exist from well-designed prospective trials,emphasis is given to results from large ries and reports from recognized experts.
Guidelines for appropriate utilization of endoscopy are bad on a critical review of the available data and expert connsus.Further controlled clinical studies are needed to clarify aspects of this statement,and revision may be necessary as new data appear.Clinical consideration may justify a cour of action at variance to the recommendations.
INTRODUCTION
The safety and the efficacy of GI endoscopy in pregnant patients is not well studied.Studies involving
humans tend to be small and retrospective.Much of the drug safety data is bad on animal studies.Invasive procedures are justified when it is clear that by not doing so could expo the fetus and/or the mother to harm.Informed connt should include risks to the fetus as well as the mother.
The fetus is particularly nsitive to maternal hypoxia and hypotension,either of which may cau fetal hypoxia that can lead to fetal demi.1Maternal overdation,with resulting hypoventilation or hypotension,or maternal positioning that might lead to inferior vena caval com-pression by the gravid uterus can lead to decread uterine bloodflow and fetal hypoxia.Other potential risks to the fetus include teratogenesis(both from medication given to the mother and radiation exposure fromfluoroscopy)and premature birth.
In situations where therapeutic intervention is neces-sary,endoscopy offers a relatively safe alternative to radiologic or surgical intervention.1-4The main indications for endoscopy in pregnancy are outlined in T able1. General principles that apply to endoscopy in pregnancy are shown in T able2.
SAFETY OF COMMONLY USED MEDICATIONS FOR ENDOSCOPY DURING PREGNANCY The U.S.Food and Drug Administration lists5 categories of drugs with regard to safety during pregnancy (
T able3).There are no category A drugs ud for endoscopy.For u during endoscopic procedures, category B and,when necessary,category C drugs are recommended.Category D drugs may be ud when the benefits clearly outweigh the risks.The categories are of limited value for determining the safety of one-time u; therefore,consultation with an obstetrician regarding medication should be considered.For most procedures, the level of dation should be anxiolysis or moderate dation.If deep dation is necessary,it should be administered by an anesthesiologist.
Meperidine(category B)
Meperidine does not appear to be teratogenic as reported in two large studies.5,6It is preferred over morphine(category C),which cross the fetal blood–brain barrier more rapidly,and fentanyl(category C). Fentanyl(category C)
This narcotic has a rapid ont of action and a shorter patient recovery time than meperidine.Fentanyl is not teratogenic but was embryocidal in rats.7It appears safe in humans when given in low dos typical for endoscopy. Naloxone(category B)
This rapidly acting opiate antagonist cross the placenta within2minutes of intravenous administration. It does not appear to be teratogenic.Its u is contra-indicated in mothers dependent
on opiates,becau it can precipitate opiate-withdrawal symptoms.It should only be ud in respiratory depression,hypotension,or unresponsiveness in a cloly monitored tting.The
Copyrightª2005by the American Society for Gastrointestinal Endoscopy 0016-5107/2005/$30.00+0
PII:S0016-5107(04)02780-4
potential for re-dation as naloxone is metabolized should be recognized.
Benzodiazepines(category D)
Sustained u of diazepam during early pregnancy(first trimester)has been associated with cleft palate and,when ud later in the pregnancy,neurobehavioral disorders,8-10 although this association is challenged by some inves-tigators.Diazepam should not be ud for dation in pregnant women.
Midazolam,although also category D,has not been reported to be associated with congenital abnormalities. Midazolam is the preferred benzodiazepine when dation with meperidine is inadequate.Avoid the u of mid-azolam in thefirst trimester if possible.
Flumazenil(category C)
教学设计怎么写Little is known of the safety profile of this benzodiaz-epine antagonist.Although it is not teratogenic in rats and mice,it does produce subtle neurobehavioral changes in male offspring of rats expod to the drug in utero.11 Propofol(category B)
In the pregnant patient,it is recommended that propofol be administrated by an anesthesiologist,becau of its narrow therapeutic index and the importance of clo monitoring.Safety in thefirst trimester has not been well studied.12,13
Simethicone(category C)
This is a category C drug becau of a lack of studies, but,it commonly is given to pregnant women and prob-ably is safe.
Glucagon(category B)
Glucagon is an antispasmodic,commonly ud during ERCP,that is not contraindicated during pregnancy. Topical anesthetics
T opical ,lidocaine(category B),often are ud to decrea the gag reflex and to make intubation
TABLE1.Indications for endoscopy in pregnancy
1.Significant or continued GI bleeding
2.Severe or refractory naua and vomiting or abdominal pain
3.Dysphagia or odynophagia
4.Strong suspicion of colon mass
5.Severe diarrhea with negative evaluation
6.Biliary pancreatitis,choledocholithiasis,or cholangitis
7.Biliary or pancreatic ductal injury
TABLE2.General principles guiding endoscopy in pregnancy
1.Always have a strong indication,particularly in
活动计划high-risk pregnancies
2.Defer endoscopy to cond trimester whenever possible
3.U lowest effective do of dative medications
4.Wherever possible,u category A or B drugs
5.Minimize procedure time
6.Position pregnant patients in left pelvic tilt or left lateral position to avoid vena caval or aortic compression
7.Prence of fetal heart sounds should be confirmed before dation is begun and after the endoscopic procedure
8.Obstetric support should be available in the event of
a pregnancy-related complication
9.Endoscopy is contraindicated in obstetric complications such as placental abruption,imminent delivery,ruptured membranes,or eclampsia TABLE3.FDA categories for drugs ud in pregnancy Category Description
A Adequate,well-controlled studies in pregnant
women have not shown an incread risk of
fetal abnormalities
B Animal studies have revealed no evidence of
harm to the fetus;however,there are no
adequate and well-controlled studies in
pregnant women
or
Animal studies have shown an adver effect,
but adequate and well-controlled studies in
pregnant women have failed to demonstrate
a risk to the fetus
C Animal studies have shown an adver effect
and there are no adequate and well-controlled
studies in pregnant women
or
No animal studies have been conducted and
there are no adequate and well-controlled
studies in pregnant women
D Studies,adequate well-controlled or
obrvational,in pregnant women have
demonstrated a risk to the fetus;however,
the benefits of therapy may outweigh
the potential risk
X Studies,adequate well-controlled or
obrvational,in animals or pregnant women
have demonstrated positive evidence of fetal
abnormalities;u of the product is
contraindicated in women who are or may
become pregnant
ASGE guideline:guidelines for endoscopy in pregnant and lactating women
easier.One study showed no fetal malformations in293 infants withfirst trimester exposure.14It may be prudent to ask the patient to gargle and to spit out the drug instead of swallowing it when its u is deemed necessary. Antibiotics
Most antibiotics can be safely ud in pregnancy,and the indications for their prophylactic u are similar to tho in nonpregnant patients.However,some antibiotics are contraindicated becau of adver fetal effects,and others are safe in only certain trimesters.T able4sum-marizes the recommendations at prent.Further details can be obtained from ,Drugs in Pregnancy and Lactation.7
Colon-cleansing agents
The safety of polyethylene glycol(PEG)electrolyte isotonic cathartic solutions has not been studied in pregnancy.PEG solutions are category C.Sodium phos-phate preparations(category C)may caufluid and electrolyte abnormalities and should be ud with cau-tion.15T ap water enemas may be sufficient forflexible sigmoidoscopy.
PROCEDURES
For all endoscopy procedures,it is suggested that the patient who is in the cond or third trimester not lie on her back while waiting for the procedure or afterward in recovery.This is becau the pregnant uterus can compress the aorta and/or the inferior vena cava(IVC), causing maternal hypotension and decread placental perfusion.By placing a wedge or pillow under the right hip,a‘‘p
elvic tilt’’is created to prevent this.The patient also may sit up if she so prefers,becau this will prevent IVC compression.Most procedures are done in the left lateral position where this is not an issue.Pregnant pa-tients also are more likely to aspirate gastric contents or cretions than nonpregnant ones.In addition to the usual patient monitoring,maternal–fetal monitoring should be performed as in T able2.Consultation with an obstetrician should be considered before endoscopy.Procedural considerations in pregnancy Upper endoscopy is performed as in nonpregnant patients.Ca ries and ca-control studies suggest it is safe and effective.5,16In a ca-control study of83upper endoscopies(EGD)performed during pregnancy,the diagnostic yield for upper-GI bleeding was95%.In this study,EGD did not induce premature labor and no congenital malformations were reported.17Studies asss-ing the safety of colonoscopy in pregnancy involve ex-tremely small numbers,limiting the ability to detect uncommon adver outcomes.18,19In late pregnancy,pa-tients should not be placed supine or prone during colonoscopy.If external abdominal pressure is required, great care should be taken to apply mild force and to direct it away from the uterus.
ERCP
ERCP should only be ud when therapeutic interven-tion is intended.Biliary pancreatitis,choledocho
lithiasis, or cholangitis are the usual indications,and can lead to fetal loss if not treated properly.Several studies have confirmed the safety of ERCP in pregnancy.20-22The fetus should be shielded from the ionizing radiation.23Lead shields are placed under the pelvis and lower abdomen, remembering that the x-ray beam originates from beneath the patient.Measuring radiation exposure to the area of the uterus also should be considered.Radiation exposure is reduced by collimating the beam to the area of interest. U brief‘‘snapshots’’offluoroscopy to confirm cannula position and common bile-duct stones.Avoid taking hard-copy x-rayfilms,becau the involve additional radia-tion.Consultation with a radiologist or a hospital radiation safety officer may be uful in minimizing the radiation exposure to the fetus.With thoughtful precaution,the fetal exposure is well below the5-to10-rad level considered to be of concern for radiation-induced teratogenesis.23,24Only experienced endoscopists should attempt the procedure.
Electrocautery and hemostasis
Amnioticfluid can conduct electrical current to the fetus.25The grounding pad should be placed in such a position that the uterus is not between the electrical
TABLE4.Antibiotic safety in pregnancy
Safe in pregnancy青果校园
Avoid in
pregnancy
Avoid in first烟草培训
trimester
Avoid in third
trimester
Penicillins Quinolones Metronidazole Sulfonamides
Cephalosporins Streptomycin Nitrofurantoin
Erythromycin
(except estolate)
Tetracyclines
Clindamycin
ASGE guideline:guidelines for endoscopy in pregnant and lactating women
catheter and the grounding pad.Bipolar electrocautery should be ud to minimize this risk of‘‘stray’’currents going through the fetus.Although electrocautery is rela-tively safe when ud for sphincterotomy and hemostasis, polyp removal should be postponed until after pregnancy.
Epinephrine is pregnancy category C and caus a decrea in uterine bloodflow.26Its safety,when ud as an endoscopic injectant,has not been studied, although,when given in low-do combinations for analgesia,it is safe.Its u for hemostasis should balance the benefits with the potential risks.27
BREAST-FEEDING
Indications and contraindications
Diagnostic and therapeutic endoscopy in lactating women do not vary in terms of indication,preproce
dural preparation,procedural monitoring,radiation exposure, and endoscopic equipment.Caution needs to be exer-cid in the u of certain medications,becau the drugs may be transferred to the infant through breast milk.In the instances,where there is a concern regarding the transfer to the infant,the woman should be advid to pump her breast milk and discard it,with the timing dependent upon the agent of concern. Sedation and analgesia
31岁The nsitivity to and risks of dation in a lactating woman is similar to any adult.7
Midazolam.Midazolam is excreted in breast milk. However,a study of12women receiving15mg midazolam orally found no measurable concentrations(!10nmol/L) in milk samples obtained7hours after ingestion.28 Additional investigations on two women showed that midazolam and its metabolite,hydroxymidazolam,were undetectable after4hours.27The American Academy of Pediatrics considers the effects of midazolam unknown on the nursing infant,but the drug may be of concern.29 Bad on the data,it would be advisable to recommend withholding nursing of the infant for at least4hours after administration of midazolam.
Fentanyl.Fentanyl is excreted in breast milk,but the concentrations are too low to be pharmacologically significant and fall to undetectable levels by10hours after administration.30The A
merican Academy of Pediatrics considers fentanyl to be compatible with breast-feeding.28 Meperidine.Meperidine is concentrated in breast milk and may be detectable up to24hours after administration.31Studies have suggested that meperidine can be transferred to the breast-fed infant and may have neurobehavioral effects.32-34Whereas,the American Acad-emy of Pediatrics classified meperidine as compatible with breast-feeding in their1983statement,it may be reason-able to u an ,fentanyl,where possible.
Propofol.Propofol is excreted in breast milk,with maximum concentrations at4to5hours after adminis-tration.35The effects of small oral dos of propofol on the infant is unknown.Continued breast-feeding after propofol exposure is not recommended,although the period of prohibition has yet to be determined.
Naloxone andflumazenil.The safety of naloxone andflumazenil in this tting is unknown.
Antibiotics
Penicillins and cephalosporins.Penicillins and ceph-alosporins are excreted in breast milk in trace amounts and are considered compatible with breast-feeding.
Ofloxacin and ciprofloxacin.Ofloxacin and cipro-floxacin are excreted in breast milk,and their toxicity has not been well studied.
Quinolones.As there is a potential for arthropathy in the infant,quinolones should be avoided.
Sulfonamides.Sulfonamides are contraindicated when nursing infants younger than2months becau of the risk of kernicterus.It is recommended that sulfona-mides be avoided in infants that are ill,premature,and gluco-6-phosphate dehydrogena deficient.36The safety of commonly ud antibiotics are summarized in T able5.
SUMMARY
For the following points:(A),Prospective controlled trials.(B),obrvational studies.(C),Expert opinion.
d Endoscopy during pregnancy should only b
e done when there is a strong indication and should be post-poned to the cond trimester whenever possible.(C)
d Th
e clo involvement o
f obstetrical staff is recom-mended.(C)
TABLE5.Antibiotic safety in breast-feeding
Safe Avoid
Penicillins Sulfonamides
Cephalosporins Quinolones
Erythromycin Metronidazole
(effect on infant
unknown,may be
of concern)
Tetracycline
Nitrofurantoin
(except in infants
with gluco-6-phosphate
dehydrogena deficiency)
ASGE guideline:guidelines for endoscopy in pregnant and lactating women
d Th
e degree o
f maternal and fetal monitorin
g needs to be individualized.(C)
d For procedural dation during pregnancy,meperi-din
平邮
e alone is preferred,followed by small dos o
f midazolam as needed.(C)
d If deep dation is needed,it should b
e administered by an anesthesiologist.(C)
d EGD and colonoscopy generally ar
e safe during pregnancy.(C)
d ERCP generally is safe,provided car
e is taken to minimize radiation exposure to the fetus(B)and risks to the mother.(C)
d Bipolar electrocautery is preferred over monopolar. Th
e monopolar grounding pad should be placed to minimizeflow o
f electrical current through the amniotic fluid.(C)
d In lat
e pregnancy,women should be placed in the lateral decubitus position during and after the procedure.
(C)
d Although many antibiotics can b
e safely ud in pregnancy,some are contraindicated(quinolones,strep-tomycin,tetracyclines),whereas others are safe only in certain stages o
f fetal development.(B)
d Breast-feeding may b
e continued after maternal fentanyl administration(B),which is preferred over meperidine.(C)
d Infants should not b
e breast-fed for at least4hours after maternal midazolam administration.(B)
d Continued breast-feeding after maternal propofol exposur
大乔攻略e is not recommended,although the period o
f prohibition is unknown.(C)
d Penicillins,cephalosporins,tetracyclines,and eryth-romycin ar
e compatible with breast-feeding.Quinolones and sulfonamides should be avoided.(C)
ACKNOWLEDGMENT
The American Society for Gastrointestinal Endoscopy thanks the American College of Obstetrics and Gynecol-ogy Committee on Obstetric Practice and Stanley Zinberg, MD,MS,FACOG,Deputy Executive Vice President and Vice President,Practice Activities,for their input and review of this guideline.
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STANDARDS OF PRACTICE COMMITTEE
Waqar A.Qureshi,MD
Elizabeth Rajan,MD
Douglas G.Adler,MD
Raquel E.Davila,MD
William K.Hirota,MD
Brian C.Jacobson,MD,MPH
Jonathan A.Leighton,MD
Marc J.Zuckerman,MD
R.David Hambrick,RN,CGRN,SGNA reprentative
Robert D.Fanelli,MD,FACS,SAGES reprentative
Todd Baron,MD,Vice Chair
Douglas O.Faigel,MD,Chair
ASGE guideline:guidelines for endoscopy in pregnant and lactating women
