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NVP Management Update
1. in Pregnancy
:an update
…Caring hearts, healing hands
ISSUED IN THE INTEREST OF A HEALTHY NEXT GENERATION
Nausea & Vomiting
Dr Sharda Jain
Sec General of DGF
2. For the use of registered medical practitioner or hospital or laboratory use only
Proprietary and confidential — do not distribute
THALIDOMIDE
TRAGEDY
GERMANY 1957
10 K CHILREN –MAINLY PHOCOMELIA
50% SURVIVED
WISH TO MAKE YOU AWARE OF ONDANSETRON RELATED MALFORMATIONS IN NVP
3. For the use of registered medical practitioner or hospital or laboratory use only
Proprietary and confidential — do not distribute
THALIDOMIDE
TRAGEDY
GERMANY 1957
10 K CHILREN –MAINLY PHOCOMELIA
50% SURVIVED
EFFECT IS LINGERING 60 YEARS LATTER
4. Proprietary and confidential — do not distribute
Nausea & Vomiting in Pregnancy (NVP)
Common condition affecting approximately 85% of pregnant women
Symptoms typically appear between 4 and 9 weeks of pregnancy & are usually most
severe between 7 – 9 weeks of pregnancy
In the majority of pregnant women, the symptoms subside between 12 and 16 weeks
of pregnancy
In about 15% of women, symptoms continue up to 20 weeks of gestation; <10% of
women suffer
Lee NM and Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin North Am. 2011 Jun;40(2):309-34, vii.
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2018 May;131(5):935.
…Caring hearts, healing hands
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Risk Factors
a m
Young
Primigravida
Obese and lean
Multiple pregnancy
Women with aternal/family history of NVP
Personal history of motion sickness
Lee NM and Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin North Am. 2011 Jun;40(2):309-34, vii.
NVP: Nausea & Vomiting in Pregnancy.
…Caring hearts, healing hands
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Etiopathogenesis
The etiology of NVP is unknown, factors
have been proposed including:
Lee NM and Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin North Am. 2011 Jun;40(2):309-34, vii.
NVP: Nausea & Vomiting in Pregnancy; hCG: Human chorionic gonadotropin
if after
10+6weeks of
gestation,
other causes
need to be
considered.
Metabolic and
hormonal
stimulus –hCG &
progesterone
Immune system
dysregulation
Gastrointestinal
motility
H. pylori
infection and
psychological
predisposition
…Caring hearts, healing hands
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Hyperemesis Gravidarum (HG)
HOPITALIZATION
Protracted NVP with the TRIAD of more than 5% pre-
pregnancy weight loss, dehydration, and
electrolyte imbalance.
In a survey of 808 women who terminated their pregnancies secondary to HG, 123 (15.2%) had at least
one termination due to HG, and 49 (6.1%) had multiple terminations. Prominent reasons given for the
terminations were inability to care for the family and self (66.7%), fear that they or their baby could die
(51.2%), or that the baby would be abnormal (22%).
…Caring hearts, healing hands
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Maternal Effects of NVPHG
Lee NM and Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin North Am. 2011 Jun;40(2):309-34, vii.
Wernicke encephalopathy
Splenic avulsion
Esophageal rupture
Pneumothorax
Systematic review
demonstrated significantly
higher depression & anxiety
scale scores in women with
NVP/HG
Wernicke’s
encephalopathy due to
vitamin B1 (thiamine)
deficiency classically
presents with blurred
vision, unsteadiness, and
confusion/memory
problems/drowsiness, and
on examination, there is
usually nystagmus,
ophthalmoplegia,
hyporeflexia or areflexia,
gait and/or finger–nose
ataxia.
Severe abdominal or
epigastric pain is unusual
in NVP and HG and may
warrant further
investigation of serum
amylase levels and an
abdominal ultrasound,
and possibly esophageal
gastroduodenoscopy,
which is considered safe
in pregnancy.
NVP: Nausea & Vomiting in Pregnancy.
…Caring hearts, healing hands
Rarely seen
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Non-Pharmacologic Treatment
Treatment Recommendations
Dietary
measures
Standard recommendation to take prenatal vitamins for 1 month before
pregnancy
Frequent, small meals every 1–2 hours to avoid a full stomach
Dietary modifications should include avoiding spicy food
Emotional
support
Emotional support always be offered by a medical professional.1
Supportive psychotherapy, behavioral therapy, and hypnotherapy may be
beneficial in women with severe NVP
Ginger Ginger helps by stimulating gastrointestinal tract motility and inducing the flow
of saliva, bile, and gastric secretions
Thiamine supplementation (either oral or intravenous) should be given to all women admitted with
prolonged vomiting, especially before administration of dextrose or parenteral nutrition.
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
NVP: Nausea & Vomiting in Pregnancy
…Caring hearts, healing hands
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THIAMINE SUPPLEMENTATION (either oral or
intravenous) should be given to all women admitted with
prolonged vomiting, especially before administration of
IV fluids or parenteral nutrition.
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Pharmacology Therapy (1/3)
Agents Pregnancy category Comment
Vitamin B6 (Pyridoxine)-
doxylamine combination
Pyridoxine (category A)
and doxylamine7
Approved by the USFDA for treatment of NVP5
Recommended as first-line pharmacotherapy
Found to be safe and does not cause adverse
effects in the fetus
Dopamine antagonists
Metoclopramide
Phenothiazine medications
(Promethazine,
Prochlorperazine)
Droperidol
Metoclopramide
(category B),
promethazine,
prochlorperazine
(category C)7
Side-effects of metoclopramide include dystonia,
restlessness, and somnolence7
In 2009, the FDA added a black box warning to
metoclopramide due to the risk of tardive dyskinesia
with chronic use.
Side-effects of droperidol include drowsiness,
dizziness, and cardiac arrythmias.
Droperidol bears black box warning as it
may cause QT prolongation and cardiac dysrhythmias.
Drug-induced extrapyramidal symptomsoculogyric crises can occur with the use of phenothiazines
and metoclopramide. If these occur, there should be prompt cessation of the medications and.
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
…Caring hearts, healing hands
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Drug-induced extrapyramidal symptomsoculogyric
crises can occur with the use of phenothiazines and metoclopramide.
If these occur, there should be prompt cessation of the medications and.
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Agents Pregnancy category Comment
Antihistamines
Diphenhydramine
Dimenhydrinate
Category B. Side effects include drowsiness, dizziness and
fatigue.
Serotonin
5-hydroxy tryptamine type 3 (5-HT3)
receptor antagonists
Ondansetron
Category B. Common adverse effects of ondansetron
include headache, drowsiness, fatigue, and
constipation.5
Ondansetron can prolong the QT interval,
especially in patients with underlying heart
problems.
There is insufficient data on fetal safety with
ondansetron use.
A possible association of ondansetron use in
the first trimester and cleft palate has been
reported.
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
HISTORY OF ONDANSETRON
Pharmacology Therapy (2/3) …Caring hearts, healing hands
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Corticosteroids
Methylprednisolone
Category B. Side effects include hyperglycemia and
possible increased risk of oral facial clefts
with first trimester use.
H2 blockers
Ranitidine
Category B. Side effects include drowsiness,
dizziness, diarrhea, or constipation.
Proton pump inhibitors
Lansoprazole
Esomeprazole
Category B. Side effects include nausea, diarrhea,
fatigue.
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
Pharmacology Therapy (3/3) …Caring hearts, healing hands
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An objective and validated index of nausea and
vomiting such as the Pregnancy-Unique
Quantification of Emesis (PUQE) score can be used
to classify the severity of NVP
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Management Algorithm for outdoor patients
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
NVP: Nausea & Vomiting in Pregnancy
…Caring hearts, healing hands
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Ginger Tea/ Ginger Ale in Pregnancy
use ginger Liberally in Salad & Preparation of Food
YouTube is Full of it
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Management Algorithm for outdoor patients
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
An objective and validated index of nausea and
vomiting such as the Pregnancy-Unique
Quantification of Emesis (PUQE) score can be
used to classify the severity of NVP
NVP: Nausea & Vomiting in Pregnancy
…Caring hearts, healing hands
23. Proprietary and confidential — do not distribute
Management Algorithm
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
NVP: Nausea & Vomiting in Pregnancy
…Caring hearts, healing hands
24. Proprietary and confidential — do not distribute
Hyperemesis Gravidarum
Hyperemesis affects between 0.3% and 2.3% of all pregnancies Hospitalization
The condition is defined as uncontrolled vomiting requiring hospitalization, severe
dehydration, muscle wasting, electrolyte imbalance, ketonuria, and weight loss of more
than 5% of body weight
Most of these patients also have hyponatremia, hypokalemia
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of Pregnancy.Obstet Gynecol. 2018 May;131(5):935
…Caring hearts, healing hands
25. Proprietary and confidential — do not distribute
Management
Erick M, Cox JT, Mogensen KM. ACOG Practice Bulletin 189: Nausea and Vomiting of
Pregnancy.Obstet Gynecol. 2018 May;131(5):935
Inpatient management should be considered if there is at least one of the following:
Continued nausea and vomiting and inability to keep down oral antiemetics
Continued nausea and vomiting associated with ketonuria and/or weight loss (greater than 5%of body
weight), despite oral antiemetics
Confirmed or suspected comorbidity (such as urinary tract infection and inability to tolerate oral
antibiotics)
Intravenous (IV) fluids should be provided to replenish the lost intravascular volume. Rehydration along
with replacement of electrolytes is very important in the treatment of hyperemesis.
Normal saline or Hartmann solution are suitable solutions; potassium chloride can be added as
needed.
While replacing electrolytes, the physician must consider the risks of rapid infusion in order to prevent
such conditions as central pontine myelinolysis.
…Caring hearts, healing hands
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Normal saline with additional potassium chloride
in each bag, with administration guided by daily
monitoring of electrolytes, is the most appropriate
intravenous hydration.
Dextrose infusions are not appropriate unless the
serum sodium levels are normal and thiamine has
been administered
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An Indian study demonstrated that excessive vomiting in pregnancy
(defined as vomiting that lasted beyond 5 months) was significantly (OR
4.48, 95% CI 1.10–18.28) associated with underweight children (in those
aged less than 3 years) compared with vomiting lasting less than 5 months.
When women with severe HG are considered, it has been shown that
those requiring repeated admissions have an 18% incidence of small-for-
gestational-age babies and significantly lower birthweights than babies of
women with HG and single admissions.
Sanghvi U, Thankappan KR, Sarma PS, Sali N. Assessingpotential risk factors for child malnutrition in rural Kerala,India. J Trop Pediatr2001;47:350–5.
Association Between Excessive Vomiting in
Pregnancy and Underweight Children
…Caring hearts, healing hands
28. STORY OF ONDANSETRON
VOMING OF POST CANCER
SURGERY ,CHEMOTHERAPY &
RADIOTHERAPY
PREGNANCY USE INCREASED LEFT & RIGHT ,THOUGH
FDA NEVER APPROVED IT FOR PREGNANCY
LITIGATION IN USA COARTS
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First Trimester
ondansetron exposure
increases risk of
cardiac birth defects in
the offspring
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Cardiac teratogenicity of ondansetron could be related to
the drug’s potential to prolong the QT interval , thereby
causing embryonic cardiac arrhythmia resulting in
reduced blood & oxygen supply t the developing heart &
subsequently causing reperfusion damage ,
including septal defects
A total of 864,083 MOTHER – CHILD pairs were identified in the study ,
early exposure to ondansetron occurred in 76,330 Mother – child pairs (8.8%) and
early exposure to medical administration of ondansetron occurred in 5,557 mother – child pairs (0.64%)
Ondansetron & pregnancy understanding the data . Obstet med 2016 mar,9(1):28-33
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Practice Pearls
• The study provided evidence of teretogenicity with first trimester ondansetron exposure
• The study conclude that women exposed to ondansetron were 2.68 & 1.62 times more likely
to give birth to children with atrioventricular septal defects & atrial septal defects,
respectively
• 1st trimester ondasetron exposure was also associated with an elevated risk of specific
structural defects such as orofacial cleft defects , circulatory defects, diaphragmatic hernia
& renal collecting system anomalies
Obstet med 2016 mar,9(1):28-33
• The findings highlighted that a significant proportion of women receive ondansetron as
a first – line therapy for NVP contrary to recommendations from the clinical guidelines
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Maternal First
Trimester Ondansetron
Use Increases Risk of
Cleft Palate in Children
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A Large Case – controlled study by the Slone Epidemiology
Centre & The Centres For Disease Control & Prevention
detected a 2- fold increased risk of claft palate with
ondansetron taken for NVP in the first trimester of
pregnancy (odds ratio (OD) 2.37 (95%) CL 1.18 to 4.76
A retrospective cohort study consisted of 1,816414 pregnancies (means age f mothers 24.3 (5.8) years
Women were considered exposed , if they filled at least one ondansetron prescription for NVP
DURING THE FIRST 3 MONTH
Ref. koren G motherisk update is ondansetron safe for use during pregnancy ?
Can fam physician . 2021 oct; 58(10):1092-3
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Practice Pearls
Maternal use of ondansetron for NVP in the 1st trimester is
associated with an increased risk of oral cleft especially cleft
palate in the offspring
From a pragmatic standpoint , ondansetron should
not be used as 1st line treatment for NVP at any stage
of pregnancy
37. IT IS IMPORTANT THAT DOCTORS
HAVE OBLIGATION & MEDICAL
DUTYNOT TO PRESCRIBE ANY
MEDICATION WHICH
INFANT,S BIRTH DEFECTS
Stop Using Ondansetron in pregnancy