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LayoutCONTINUING EDUCATION By Stefanie Tyler, MSN, WHNP-BC and Jamille Nagtalon-Ramos, MSN, WHNP-BC, IBCLC • Describe the etiology and impact of NVP.
Stefanie Tyler, MSN, WHNP-BC, is a women's health nurse
• Evaluate the need for management of NVP in the individual practitioner at Obstetrical and Gynecological Associates, PLLC, in Houston, Texas.
• Describe the safety and efficacy of available nonpharmaco- Jamille Nagtalon-Ramos, MSN, WHNP-BC, IBCLC, is a
logic and pharmacologic approaches to NVP and select the women's health nurse practitioner in the Department of Ob- appropriate strategy for each individual patient.
stetrics and Gynecology at the Hospital of the University of Credit designation statement
Pennsylvania and Associate Director of the WHNP Program at This Activity (No. J-15-05) has been evaluated and approved the University of Pennsylvania, both in Philadelphia.
by the Continuing Education Approval Program of the Na- tional Association of Nurse Practitioner in Women's Health Nurse practitioners (NPs), nurse-midwives, and other ad- (NPWH) for 1 contact hour of CE credit, including 1 contact vanced practice clinicians who care for pregnant women hour of pharmacology content. Each participant should claimonly those contact hours that he/she actually spent in the ed- Continuing education (CE) approval period
Now through August 31, 2016 Estimated time to complete this activity
NPWH policy requires all faculty to disclose any affiliation or relationship with a commercial interest that may cause a po- Program description/identification of need
tential, real, or apparent conflict of interest with the content This CE program presents practical strategies to meet the of a CE program. NPWH does not imply that the affiliation or relationship will affect the content of the CE program. Disclo- needs of NPs, nurse-midwives, and other advanced practiceclinicians who provide prenatal care for women. In particular, sure provides participants with information that may be im- the program will help clinicians identify and treat women who portant to their evaluation of an activity. Conflicts of interest have experienced nausea and vomiting of pregnancy (NVP). were resolved according to NPWH policy prior to develop- The traditional classification of NVP—that is, the continuum ment of content. Ms. Tyler reports that she has nothing to
ranging from mild to moderate to severe—is inadequate to disclose. Ms Nagtalon-Ramos is a consultant to Phillips/
characterize this condition's full effect. According to a recent Avent and provides contractual services and serves on
meta-analysis, about 70% of pregnant women experience the speaker's bureau for Merck.
NVP, and about 1.2% suffer from hyperemesis gravidarum, the most severe form of NVP. Symptoms, including nausea, gag- Disclosure of unlabeled use
ging, retching, dry heaving, and vomiting, may persist ‘round NPWH policy requires authors to disclose to participants the clock—despite the common term morning sickness. In a when presenting information about unlabeled use of a com- recent literature review, mean onset of NVP was day 39 from mercial product or device or an investigational use of a drug the last menstrual period (LMP); 13% of women began to ex- or device not yet approved for any use.
perience NVP before day 28 and 90% before day 56 (i.e., the end of week 8 after their LMP). Peak incidence of NVP oc- Participating faculty determine the editorial content of the curred during weeks 7-9. By week 16, NVP ceased in 91% of CE activity; the content does not necessarily represent the women. Recent reports indicate that NVP persists beyond views of NPWH. This content has been peer reviewed for vali- week 20 in 2.5%-10% of women.
dation of clinical content. Although every effort has been Educational objectives
made to ensure that the information is accurate, clinicians At the conclusion of this activity, participants should be bet- are responsible for evaluating this information in relation to generally accepted standards in their own communities and www.NPWOMENSHEALTHCARE.com May 2015 Women's Healthcare 7
integrating the information in this activity with those of es- pants to 1. Go to
tablished recommendations of other authorities, national and read the learning objectives, disclo- guidelines, FDA-approved package inserts, and individual pa- sures, and disclaimers; 2. study the material in the learning ac-
tivity; and 3. during the approval period, complete the activity
evaluation and score 70% or higher on the posttest.
Successful completion of this activity
Successful completion of this activity, J-15-05, requires partici-
Commercial support: Duchesnay
nadotropin (hCG) concentrations Before reading the article,to take the pretest. and peak NVP symptoms, one ofthe most likely candidates for theemetogenic stimulus arising fromthe placenta is the rising level ofhCG or one of its isoforms.10 Other Despite its pervasive nature and potential severity, nausea and vomiting of pregnancy (NVP) is frequently regarded as something a woman must endure—even though authors theorize that NVP may effective management of the condition can greatly improve serve as the body's natural mecha-nism for avoiding ingestion of ter- quality of life, reduce risks for maternal and fetal complications, atogenic substances during em- and cut healthcare and societal costs. To help healthcare providers and their pregnant patients reach these goals, this article details the scope, etiology, impact, assessment, and management of NVP.
Although the etiology of NVP hasnot been precisely determined, its KEY WORDS: nausea and vomiting of pregnancy, NVP, quality of life,
effect on pregnant women is clear.
Studies utilizing a wide range ofmeasurement tools have identi-fied detrimental and far-reaching Scope of the problem
of week 8 after their LMP). Peak consequences of NVP on maternal The traditional classification of incidence of NVP occurred dur - QOL.7 In particular, women report nausea and vomiting of preg- ing weeks 7-9. By week 16, NVP adverse effects of NVP on physical nancy (NVP)—that is, the contin- ceased in 91% of women. Recent functioning, energy, social func- uum ranging from mild to moder- reports indicate that NVP persists tioning, work, performance of ate to severe—is inadequate to beyond week 20 in 2.5%-10% of household duties, and parent- characterize this condition's full ef- ing.13,14 A prospective study of fect.1-3 According to a recent 367 pregnant women who com- meta-analysis, about 70% of preg- pleted a QOL questionnaire nant women experience NVP, and To address the unpleasant symp- showed that those with moderate about 1.2% suffer from hypereme- toms of NVP and the adverse im- to severe NVP had scores similar to sis gravidarum (HG), the most se- pact of the condition on quality of those of women with breast can- vere form of NVP.4 Symptoms, in- life (QOL), it would be useful to cer or myocardial infarction, and cluding nausea, gagging, retching, know the etiology. Unfortunately, those with severe NVP had QOL dry heaving, and vomiting, may although several theories have likened to postnatal depression.15 persist ‘round the clock—despite been proposed, the etiology of In fact, studies suggest that the common term morning sick- NVP has not yet been clearly de- NVP of any magnitude can jeop- ness.3,5 In a recent literature re- fined.9 NVP is most likely due to a ardize women's mental health.15 view, mean onset of NVP was day complex interplay of hormonal, An interesting aspect of the bur- 39 from the last menstrual period metabolic, physiologic, and psy- den that NVP places on a woman (LMP)6; 13% of women began to chosocial factors.5 Because of the and her psyche is that this condi- experience NVP before day 28 and close temporal association be- tion is considered a normal part of 90% before day 56 (i.e., the end tween peak human chorionic go- pregnancy; frequent nausea and 8 May 2015 Women's Healthcare www.NPWOMENSHEALTHCARE.com
vomiting (N/V) in any other set- Differential diagnosis
should order laboratory tests for ting would be considered patho- Although NVP is the most obvi- urinary ketones, blood urea nitro- logic and worthy of evaluation, di- ous diagnosis when a pregnant gen, creatinine, liver enzymes, agnosis, management, and wom an presents with N/V, it is electrolytes, amylase, and thyroid- emotional support. As a result, not the only possibility. An im- stimulating hormone.8 Ultrasonog- NVP might not be taken as seri- portant distinguishing feature of raphy is recommended to check for ously because it is so common NVP is that it begins prior to 10 multiple gestation or molar gesta- and because it is temporary, lead- weeks' gestation; N/V onset after tion. If other causes of N/V have ing some sufferers to feel frus- 10 weeks usually has an alternate been ruled out, and if a woman's trated and guilty that they are cause. A history and physical ex- symptoms are severe and persist- even complaining about their amination should rule out these ent, HCPs should investigate possi- ble complications such as dehydra- Nausea and vomiting of preg- • Gastrointestinal disorders such
tion and thiamine deficiency.
nancy can take a physical and psy- as gastroenteritis, cholecystitis, Providers may base their initial chological toll on a pregnant hepatitis, peptic ulcer disease, approach to NVP management on woman, and may have an adverse pancreatitis, appendicitis, and a woman's subjective description effect on her partner, family mem- Helicobacter pylori infection; of her symptoms. To obtain a more bers, and even co-workers. How- • Genitourinary tract disorders
complete picture, they can add ever, mild to moderate NVP has not such as pyelonephritis or uremia; objective measures that not only been shown to harm the fetus and • Metabolic disorders such as dia-
help define the magnitude of the may, in fact, be associated with fa- betic ketoacidosis, porphyria, problem but also help them moni- vorable pregnancy outcomes, par- Addison's disease, and tor treatment response. Several ticularly in terms of rates of miscar- objective measures are available, riage, congenital malformations, • Neurologic disorders such as
including the Pregnancy-Unique and preterm births.17 Of note, vestibular lesions, migraines, Quantification of Emesis and Nau- though, infants of HG sufferers may and central nervous system sea (PUQE) scale,21 the Nausea be born prematurely, be small for and Vomiting of Pregnancy Instru- gestational age, have significantly • Infections and drug toxicity/
ment,22 the modified PUQE lower birth weights, or have 5- scale,23 the Health-Related Quality minute Apgar scores <7.18 of Life for Nausea and Vomiting NVP is a diagnosis of exclusion.3 during Pregnancy (NVPQOL) ques- Assessment
tionnaire,24,25 and the 24-hour The first step in assessment of a PUQE (PUQE-24) scale.26 pregnant patient who reports ex- Certain physical findings may periencing distressful N/V is to suggest conditions other than rule out other possible causes of pregnancy that are causing the Clinical evidence suggests that the N/V besides pregnancy itself.
N/V. These findings include ab- use of antiemetics earlier in preg- Healthcare providers (HCPs) dominal pain/tenderness that nancy may improve maternal QOL, should ask about the onset, tim- precedes N/V or that is out of pro- prevent severe NVP—along with ing, and severity of the N/V; ag- portion to the N/V (although associated maternal and fetal gravating and alleviating factors; some epigastric pain secondary complications—and reduce hospi- and appearance of the vomitus.3,8 to prolonged retching may occur tal-related costs.17,27 Because the A clinical picture of a positive with NVP); fever, which is not etiology of NVP has not been de- pregnancy test result coupled present in NVP; and concurrent termined, management is directed with N/V that (1) began 30-60 neurologic findings such as at symptoms. A reasonable ap- days after a patient's LMP, (2) oc- headache, neck stiffness, and/or proach, which is individually tai- curs nearly every day between 9 changes in vision.20 lored, depends on symptom sever- AM and noon, and (3) is relieved ity and the potential impact of to some degree by eating dry treatment on the patient and the foods or carbohydrates is likely to When a cause of N/V other than fetus. For mild to moderate NVP, represent NVP.
pregnancy is suspected, HCPs dietary and lifestyle alterations www.NPWOMENSHEALTHCARE.com May 2015 Women's Healthcare 9
may be sufficient. Some patients OTC and CAM therapies
stated that pyridoxine, alone or in may prefer to try OTC (over-the- Systematic reviews of random - combination with doxylamine, an counter) or CAM (complementary iz ed and/or controlled trials have H1-receptor antagonist usually and alternative medicine) thera- shown that pyridoxine (vitamin B6) used as an antihistamine or hyp- pies before progressing to phar- improves mild to moderate nausea notic, is safe and effective for NVP macologic interventions. However, but does not significantly reduce and should be considered first-line pharmacologic treatment may be vomiting27,32 or it has limited evi- pharmacotherapy.37 If OTC pyri- necessary and beneficial for some dence of efficacy.5 When used as doxine 25 mg TID alone is inade- patients if symptoms persist. Pa- monotherapy, the initial dosage of quate in easing symptoms, pa- tients with severe NVP may re- pyridoxine is 25 mg orally every tients can add OTC doxylamine quire hospitalization and exten- 6-8 hours; the maximum dosage 12.5 mg (one-half tablet of Uni- sive medical management.
suggested for pregnant women is som SleepTabs) TID. However, this 200 mg/day.33 A 2014 systematic OTC regimen has its drawbacks: (1) Avoidance of triggers
review and meta-analysis of ran- several Unisom products are avail- Many women with NVP report that domized trials showed that ginger, able; only one of them contains certain odors stimulate or exacer- relative to placebo, improved nau- doxylamine; (2) patients must split bate N/V. Avoiding stimuli such as sea but not vomiting.34 A common the small 25-mg tablet in half to pungent odors from food and per- dosage is powdered ginger 500- get the correct dose; (3) patients fumes or visual stimuli may allevi- must take two separate pills 3-4 ate their symptoms.28 A suggested Acupressure using a wristband times a day; and (4) these immedi- strategy is to maintain a food di- or manual pressure at the P6 (Nei- ate-release OTC formulations may ary, which may help determine Guan) point, located 4.5 cm above not "cover" patients 24/7.3 tastes, textures, and odors that the wrist on the palmar side of the In April 2013, the FDA approved trigger N/V.
forearm, is a common treatment Diclegis,® a combination of de- for NVP.35 One such wristband, layed-release doxylamine 10 mg PrimaBella®, has been approved and pyridoxine 10 mg, for the The most common dietary recom- by the FDA for this indication.36 treatment of NVP.38 This product is mendations are to eat frequent However, a 2014 systematic review the only FDA Pregnancy Category small meals/snacks composed of of randomized trials did not find A-approved therapy specifically in- high-carbohydrate, low-fat foods, P6 acupressure wristbands to be dicated for NVP.3,39 Diclegis is ini- with protein added to every snack significantly more effective than tially given as two delayed-release and meal; and to avoid an empty pills at bedtime; if symptoms are stomach.19,29-31 For many women, Clinical evidence to support the not adequately controlled, the eating dry food or carbohydrates efficacy of hypnosis or psycho - dose can be increased to a maxi- before getting out of bed in the therapy as a primary treatment for mum of four tablets daily (one in morning is helpful. Drinking liq- NVP is insufficient. Supportive the morning, one mid-afternoon, uids in between meals, instead of therapy, counseling, or a review of and two at bedtime).3,40 with meals, helps avoid gastric dis- psychological factors in cases with A doxylamine-pyridoxine com- tention. Patients should be reas- persistent NVP symptoms, is rec- bination pill, previously called sured that their diet during preg- Bendectin, was removed from the nancy, even if not "ideal," will not U.S. market in 1983 following un- founded allegations that it caused These dietary recommendations Dietary changes and OTC/CAM birth defects. Since that time, nu- apply to women with HG. However, therapy, if tried, may not be suffi- merous meta-analyses and stud- in women with HG who have sus- cient in easing NVP symptoms. If ies have supported the safety of tained significant weight loss, nutri- so, patients may benefit from this product—in fact, no other tional deficiencies may result in a pharmacotherapy. agents given in pregnancy have compromised fetus or, at the least, more conclusive safety data with cause some harm to the mother.31 regard to teratogenicity.39,41 In In these cases, more aggressive in- The American Congress of Obste- addition, a major trial, which was terventions are needed.
tricians and Gynecologists has requested by the FDA before it 10 May 2015 Women's Healthcare www.NPWOMENSHEALTHCARE.com
would grant approval for Diclegis, (PO) every 4-6 hours or 10-50 mg ized controlled trial comparing showed evidence of efficacy.42 intravenously (IV) or intramuscu- metoclopramide and prometh - In this double-blind study, 161 larly (IM) every 4-6 hours as azine for the treatment of HG women with NVP were random- needed; meclizine 25 mg PO every showed no difference in efficacy, ized to receive extended-release 4-6 hours as needed; and dimen- although metoclopramide was less doxylamine-pyridoxine (n = 131) hydrinate 50-100 mg PO or rectally sedating.47 Recommended dosing or placebo (n = 125) for 14 days; (PR) every 4-6 hours as needed.44 is metoclopramide 5-10 mg PO or active treatment, as compared IV every 6 hours as needed.44 with placebo, resulted in a signifi- Dopamine antagonists
cantly larger improvement in NVP For women who do not respond to 5-HT3 antagonists
symptoms based on both PUQE doxylamine and/or pyridoxine, an- If NVP symptoms are still inade- score (–4.8 ± 2.7 vs. –3.9 ± 2.6; other option is to substitute or add quately controlled, women can try P = .006) and QOL. If delayed- a drug from an different category a serotonin 5-hydroxytryptamine such as a dopamine antagonist.
3-receptor (5-HT3) antagonist alone does not relieve patients' Within this category are pheno thia - such as ondansetron (Zofran®), symptoms to a sufficient extent, zine antiemetics (e.g., prochlorper- granisetron (Kytril®), or dolasetron then alternate or additional inter- azine [Compazine®], promethazine (Anzemet®). Although these ventions can be explored.
[Phenergan®]) and meto clopramide agents are used primarily for (Reglan®), which has antiemetic and chemotherapy-related N/V, they H1-receptor antagonists
prokinetic effects.3 are widely used for NVP—espe- Other H1-receptor antagonists be- A major downside of the phe- cially because, until early 2013, sides doxylamine can be tried, in- nothiazines is that, although effec- there were no FDA-approved cluding diphenhydramine (e.g., Be- tive as antiemetics, these agents drugs for NVP.3,48 In fact, the use nadryl®), dimenhydrinate (e.g., can cause sedation, hypotension, of ondansetron for NVP has in- Dramamine®), meclizine (e.g., An- dry mouth, and extrapyramidal creased from 50,000 monthly pre- tivert®), cyclizine (Marezine®), and symptoms. Although the FDA has scriptions in 2008 to 110,000 hydroxyzine (e.g., Vistaril®). If any placed phenothiazines in Preg- monthly prescriptions in 2013, de- of these agents is added to dox yl - nancy Category C, multiple obser- spite unresolved concerns regard- amine or Diclegis, low doses are vational studies of patients ex- ing fetal safety (e.g., risk for cleft used to avoid compounding anti- posed to various these agents have palate in the newborn49) and FDA histamine side effects such as ex- failed to demonstrate an increased warnings about serious maternal cess drowsiness. Pooled data from risk for major malformations.45 seven controlled trials indicated No specific dosing guidelines for Using a large Danish birth reg- that antihistamines are effective in the phenothiazines exist for preg- istry, two groups of researchers reducing vomiting in pregnant nant women. Possible regimens are reached different conclusions re- women and appear to have a pro- those established for adults and in- garding the safety of ondansetron: tective effect in terms of the risk clude promethazine 12.5-25 mg PO Pasternak et al50 reported that on- for fetal malformations.24 A pre - or PR every 4-6 hours as needed dansetron was not associated with vious meta-analysis of 24 con- (promethazine has a black-box increased rates of spontaneous trolled studies enrolling a total of warning for severe tissue injuries abortion, stillbirth, major birth de- more than 200,000 women using with IV or subcutaneous adminis- fects, preterm delivery, low birth antihistamines during pregnancy tration) and prochlorperazine 5-10 weight, or small size for gesta- had shown no link of the drugs to mg PO or 10-25 mg PR every 6 tional age, whereas Andersen et birth defects or serious adverse hours as needed.44 al51 found a 2-fold increased risk maternal or fetal outcomes.43 Be- In terms of metoclopramide, a for cardiac malformations. cause no specific H1-receptor Pregnancy Category B agent, the Data from a large Swedish birth blocker dosing guidelines con- largest study to date, published in registry and a Swedish registry of cerning pregnant women are avail- 2013, showed no increased risk for prescribed drugs were reviewed to able, standard adult dosages are major congenital malformations investigate the teratogenic effects with more than 28,000 first- of ondansetron.52 A total of 1349 diphenhydramine 25-50 mg orally trimester exposures.46 A random- infants born of women who had www.NPWOMENSHEALTHCARE.com May 2015 Women's Healthcare 11
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Mazzotta P, Magee LA. A risk- For readers of the online benefit assessment of pharmacological and nonpharmacological treatments Viljoen E, Visser J, Koen N, for nausea and vomiting of preg- to participate in this CE Musekiwa A. A systematic review and meta-analysis of the effect and safety Pasternak B, Svanström H, Møl- of ginger in the treatment of preg- gaard-Nielsen D, et al. Metoclo- www.NPWOMENSHEALTHCARE.com May 2015 Women's Healthcare 13
Social Movements and Social Policy: The Bolivian Renta Dignidad Political Science Department, University of North Carolina at Chapel Hill Sara Niedzwiecki* Political Science Department, University of New Mexico, Albuquerque email@example.com (856) 725-3672 * We would like to thank Evelyne Huber, John Stephens, and Camila Arza for comments on previous versions of this paper.
Sonderdruck Nr. 1501 aus gwa 3/2007 des Schweizerischen Vereins des Gas- und Wasserfaches (SVGW), Zürich Irene Hanke, Eawag Umweltchemie Heinz Singer, Eawag Umweltchemie Christa McArdell-Buergisser, Eawag Umweltchemie Matthias Brennwald, Eawag Wasserressourcen und Trinkwasser Daniel Traber, Bundesamt für Umwelt (BAFU), Gruppe NAQUA Reto Muralt, Bundesamt für Umwelt (BAFU), Gruppe NAQUA Thilo Herold, Bundesamt für Umwelt (BAFU), Gruppe NAQUA Rahel Oechslin, Amt für Lebensmittelkontrolle und Umweltschutz des Kantons Schaffhausen Rolf Kipfer, ETH Zürich, Institut für Isotopengeologie und mineralische Rohstoffe