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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
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
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
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.
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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
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Peter’s Principle
(25-50-25)
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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 NVPHG
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.
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
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.
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
PUQE Index …Caring hearts, healing hands
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
P6 Acupressure Point
Proprietary and confidential — do not distribute
Proprietary and confidential — do not distribute
Ginger Tea/ Ginger Ale in Pregnancy
use ginger Liberally in Salad & Preparation of Food
YouTube is Full of it
Proprietary and confidential — do not distribute
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
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
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
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
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
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
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
Proprietary and confidential — do not distribute
Proprietary and confidential — do not distribute
Proprietary and confidential — do not distribute
First Trimester
ondansetron exposure
increases risk of
cardiac birth defects in
the offspring
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
Maternal First
Trimester Ondansetron
Use Increases Risk of
Cleft Palate in Children
Proprietary and confidential — do not distribute
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
Proprietary and confidential — do not distribute
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
IT IS IMPORTANT THAT DOCTORS
HAVE OBLIGATION & MEDICAL
DUTYNOT TO PRESCRIBE ANY
MEDICATION WHICH
INFANT,S BIRTH DEFECTS
Stop Using Ondansetron in pregnancy
Proprietary and confidential — do not distribute

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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
  • 5. Proprietary and confidential — do not distribute 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
  • 6. Proprietary and confidential — do not distribute 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
  • 7. Proprietary and confidential — do not distribute Peter’s Principle (25-50-25)
  • 8. Proprietary and confidential — do not distribute 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
  • 9. Proprietary and confidential — do not distribute Maternal Effects of NVPHG 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
  • 10. Proprietary and confidential — do not distribute 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
  • 11. Proprietary and confidential — do not distribute 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.
  • 12. Proprietary and confidential — do not distribute 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
  • 13. Proprietary and confidential — do not distribute 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.
  • 14. Proprietary and confidential — do not distribute 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
  • 15. Proprietary and confidential — do not distribute 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
  • 16. Proprietary and confidential — do not distribute 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
  • 17. Proprietary and confidential — do not distribute PUQE Index …Caring hearts, healing hands
  • 18. Proprietary and confidential — do not distribute 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
  • 19. Proprietary and confidential — do not distribute P6 Acupressure Point
  • 20. Proprietary and confidential — do not distribute
  • 21. Proprietary and confidential — do not distribute Ginger Tea/ Ginger Ale in Pregnancy use ginger Liberally in Salad & Preparation of Food YouTube is Full of it
  • 22. Proprietary and confidential — do not distribute 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
  • 26. Proprietary and confidential — do not distribute 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
  • 27. Proprietary and confidential — do not distribute 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
  • 29. Proprietary and confidential — do not distribute
  • 30. Proprietary and confidential — do not distribute
  • 31. Proprietary and confidential — do not distribute First Trimester ondansetron exposure increases risk of cardiac birth defects in the offspring
  • 32. Proprietary and confidential — do not distribute 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
  • 33. Proprietary and confidential — do not distribute 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
  • 34. Proprietary and confidential — do not distribute Maternal First Trimester Ondansetron Use Increases Risk of Cleft Palate in Children
  • 35. Proprietary and confidential — do not distribute 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
  • 36. Proprietary and confidential — do not distribute 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 DUTYNOT TO PRESCRIBE ANY MEDICATION WHICH INFANT,S BIRTH DEFECTS Stop Using Ondansetron in pregnancy
  • 38. Proprietary and confidential — do not distribute