Page last updated: 2024-11-01

ondansetron and Complications, Pregnancy

ondansetron has been researched along with Complications, Pregnancy in 20 studies

Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

Research Excerpts

ExcerptRelevanceReference
"To examine the risk of birth defects in children born to women who used ondansetron early in pregnancy for nausea and vomiting of pregnancy or hyperemesis gravidarum."8.93Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review. ( Carstairs, SD, 2016)
"To examine the medical evidence regarding the clinical efficacy and cost-effectiveness of the application of continuous subcutaneous metoclopramide and ondansetron to treat nausea and vomiting during pregnancy."8.88Reviewing the evidence for using continuous subcutaneous metoclopramide and ondansetron to treat nausea & vomiting during pregnancy. ( Kirkbride, MS; Reichmann, JP, 2012)
"The objective of this study was to describe ondansetron drug utilization patterns during pregnancy to treat nausea and vomiting in pregnancy (NVP)."8.12Ondansetron use in nausea and vomiting during pregnancy: A descriptive analysis of prescription patterns and patient characteristics in UK general practice. ( Candore, G; Flynn, R; Kurz, X; Nordeng, H; Pinheiro, L; Quinten, C; Slattery, J, 2022)
"Ondansetron is an effective antiemetic that is being widely used as a second-line treatment option for severe nausea and vomiting of pregnancy in accordance with clinical guidelines."8.02Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC). ( Cassina, M; Damkier, P; Diav-Citrin, O; Kaplan, YC; Shechtman, S; Weber-Schoendorfer, C, 2021)
" The rash started 2 days after the patient had started taking ondansetron 8 mg for alleviation of moderate-to-severe nausea and vomiting of pregnancy."7.88Pityriasis rosea-like eruption associated with ondansetron use in pregnancy. ( Alame, MM; Chamsy, DJ; Zaraket, H, 2018)
"To use data from two large studies of birth defects to describe time trends in ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy and to investigate associations, either previously reported or undescribed, between first-trimester ondansetron use and major birth defects."7.88Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects. ( Anderka, M; Mitchell, AA; Parker, SE; Van Bennekom, C, 2018)
"Ondansetron is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for the fetus has not been well studied."7.79Ondansetron in pregnancy and risk of adverse fetal outcomes. ( Hviid, A; Pasternak, B; Svanström, H, 2013)
"This is a descriptive retrospective case series of 14 pregnant women treated with ondansetron for hyperemesis gravidarum (HG) at CHU Sainte-Justine, from January 2002 to October 2011."7.78Ondansetron use during pregnancy: a case series. ( Bussières, JF; Ferreira, E; Gillet, M; Lelièvre, J, 2012)
"Ondansetron (Zofran) is a drug used for the treatment of nausea and vomiting caused by cancer chemotherapy."7.72The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study. ( Einarson, A; Kennedy, D; Koren, G; Maltepe, C; Navioz, Y; Tan, MP, 2004)
"To examine the risk of birth defects in children born to women who used ondansetron early in pregnancy for nausea and vomiting of pregnancy or hyperemesis gravidarum."4.93Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review. ( Carstairs, SD, 2016)
"For mild symptoms of nausea and emesis of pregnancy, ginger, pyridoxine, antihistamines, and metoclopramide were associated with greater benefit than placebo."4.93Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy: A Systematic Review. ( Beyer, F; Bradley, J; Bryant, A; McParlin, C; Moloney, E; Muirhead, CR; Nelson-Piercy, C; Newbury-Birch, D; Norman, J; O'Donnell, A; Robson, SC; Shaw, C; Simpson, E; Swallow, B; Vale, L; Yates, L, 2016)
"To examine the medical evidence regarding the clinical efficacy and cost-effectiveness of the application of continuous subcutaneous metoclopramide and ondansetron to treat nausea and vomiting during pregnancy."4.88Reviewing the evidence for using continuous subcutaneous metoclopramide and ondansetron to treat nausea & vomiting during pregnancy. ( Kirkbride, MS; Reichmann, JP, 2012)
"The objective of this study was to describe ondansetron drug utilization patterns during pregnancy to treat nausea and vomiting in pregnancy (NVP)."4.12Ondansetron use in nausea and vomiting during pregnancy: A descriptive analysis of prescription patterns and patient characteristics in UK general practice. ( Candore, G; Flynn, R; Kurz, X; Nordeng, H; Pinheiro, L; Quinten, C; Slattery, J, 2022)
"Ondansetron is an effective antiemetic that is being widely used as a second-line treatment option for severe nausea and vomiting of pregnancy in accordance with clinical guidelines."4.02Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC). ( Cassina, M; Damkier, P; Diav-Citrin, O; Kaplan, YC; Shechtman, S; Weber-Schoendorfer, C, 2021)
" The rash started 2 days after the patient had started taking ondansetron 8 mg for alleviation of moderate-to-severe nausea and vomiting of pregnancy."3.88Pityriasis rosea-like eruption associated with ondansetron use in pregnancy. ( Alame, MM; Chamsy, DJ; Zaraket, H, 2018)
"To use data from two large studies of birth defects to describe time trends in ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy and to investigate associations, either previously reported or undescribed, between first-trimester ondansetron use and major birth defects."3.88Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects. ( Anderka, M; Mitchell, AA; Parker, SE; Van Bennekom, C, 2018)
"Evidence for the fetal safety of ondansetron, a 5-HT3 receptor antagonist that is commonly prescribed for nausea and vomiting during pregnancy, is limited and conflicting."3.88Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring. ( Bateman, BT; Desai, RJ; Gray, KJ; Hernández-Díaz, S; Huybrechts, KF; Mogun, H; Patorno, E; Straub, L; Zhu, Y, 2018)
"Ondansetron is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for the fetus has not been well studied."3.79Ondansetron in pregnancy and risk of adverse fetal outcomes. ( Hviid, A; Pasternak, B; Svanström, H, 2013)
"This is a descriptive retrospective case series of 14 pregnant women treated with ondansetron for hyperemesis gravidarum (HG) at CHU Sainte-Justine, from January 2002 to October 2011."3.78Ondansetron use during pregnancy: a case series. ( Bussières, JF; Ferreira, E; Gillet, M; Lelièvre, J, 2012)
"Ondansetron (Zofran) is a drug used for the treatment of nausea and vomiting caused by cancer chemotherapy."3.72The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study. ( Einarson, A; Kennedy, D; Koren, G; Maltepe, C; Navioz, Y; Tan, MP, 2004)
"A client could have weight loss, dehydration, nutritional deficiencies, metabolic deficiencies, difficulty with daily activities, psychosocial stress and depression."1.35A case study approach to Hyperemesis Gravidarum: home care implications. ( Jennings-Sanders, A, 2009)

Research

Studies (20)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (5.00)18.2507
2000's4 (20.00)29.6817
2010's11 (55.00)24.3611
2020's4 (20.00)2.80

Authors

AuthorsStudies
Slattery, J1
Quinten, C1
Candore, G1
Pinheiro, L1
Flynn, R1
Kurz, X1
Nordeng, H1
Huybrechts, KF3
Hernandez-Diaz, S4
Straub, L2
Gray, KJ2
Zhu, Y2
Mogun, H2
Bateman, BT3
Damkier, P1
Kaplan, YC1
Shechtman, S1
Diav-Citrin, O1
Cassina, M1
Weber-Schoendorfer, C1
Alame, MM1
Chamsy, DJ1
Zaraket, H1
Parker, SE1
Van Bennekom, C1
Anderka, M2
Mitchell, AA2
Patorno, E1
Desai, RJ1
Kiernan, E1
Jones, KL1
Pasternak, B1
Svanström, H1
Hviid, A1
Carstairs, SD1
McParlin, C1
O'Donnell, A1
Robson, SC1
Beyer, F1
Moloney, E1
Bryant, A1
Bradley, J1
Muirhead, CR1
Nelson-Piercy, C1
Newbury-Birch, D1
Norman, J1
Shaw, C1
Simpson, E1
Swallow, B1
Yates, L1
Vale, L1
Jennings-Sanders, A1
Tan, PC1
Omar, SZ1
Louik, C1
Werler, MM1
Rasmussen, SA1
Ferreira, E1
Gillet, M1
Lelièvre, J1
Bussières, JF1
Reichmann, JP1
Kirkbride, MS1
Quinla, JD1
Hill, DA1
Schumann, R1
Hudcova, J1
Einarson, A1
Maltepe, C1
Navioz, Y1
Kennedy, D1
Tan, MP1
Koren, G1
World, MJ1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022[NCT06055192]200 participants (Anticipated)Observational2023-09-30Not yet recruiting
The Effect of Adjuvant Hypnosis Added to Conventional Therapy on Nausea and Vomiting in Hyperemesis Gravidarum: A Prospective Randomized Study[NCT04828967]41 participants (Actual)Interventional2017-01-01Completed
Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?[NCT02960113]Phase 4240 participants (Actual)Interventional2016-05-31Completed
IRB-HSR# 14583: Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients[NCT01414777]Phase 2/Phase 368 participants (Actual)Interventional2009-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Level of Nausea After Eversion of the Uterus

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after eversion of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: After eversion of the uterus until replacement of the uterus

Interventionunits on a scale (Mean)
Scopolamine Patch1.28
Acupressure Point P61.09
Scopolamine Patch + Acupressure Point P61.40

Level of Nausea After Replacement of the Uterus

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after replacement of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: After replacement of the uterus and to the next 15 minutes

Interventionunits on a scale (Mean)
Scopolamine Patch2.19
Acupressure Point P62.19
Scopolamine Patch + Acupressure Point P62.51

Level of Nausea After the Administration of the Regional Anesthesia Medications

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after the administration of the regional anesthesia medications. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: From administration of anaesthesia until eversion of uterus

Interventionunits on a scale (Mean)
Scopolamine Patch2.71
Acupressure Point P62.57
Scopolamine Patch + Acupressure Point P62.84

Level of Nausea Upon Arrival to the Post-operative Recovery Room

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) upon arrival to the post-operative recovery room. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit

Interventionunits on a scale (Mean)
Scopolamine Patch0.18
Acupressure Point P60.25
Scopolamine Patch + Acupressure Point P60.23

Number of Patients With Nausea

The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group. (NCT02960113)
Timeframe: Throughout the entire surgical procedure

InterventionParticipants (Count of Participants)
Scopolamine Patch40
Acupressure Point P639
Scopolamine Patch + Acupressure Point P646

Number of Patients With Vomiting

The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: Throughout the surgical procedure

InterventionParticipants (Count of Participants)
Scopolamine Patch24
Acupressure Point P625
Scopolamine Patch + Acupressure Point P631

Number of Patients With Vomiting After Eversion of the Uterus

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: After eversion of to replacement of the uterus

InterventionParticipants (Count of Participants)
Scopolamine Patch8
Acupressure Point P66
Scopolamine Patch + Acupressure Point P69

Number of Patients With Vomiting After Replacement of the Uterus

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: After replacement of the uterus and for next 15 minutes

InterventionParticipants (Count of Participants)
Scopolamine Patch10
Acupressure Point P615
Scopolamine Patch + Acupressure Point P612

Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: After the administration of the regional anesthesia medications until eversion of the uterus

InterventionParticipants (Count of Participants)
Scopolamine Patch20
Acupressure Point P615
Scopolamine Patch + Acupressure Point P620

Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit

InterventionParticipants (Count of Participants)
Scopolamine Patch1
Acupressure Point P61
Scopolamine Patch + Acupressure Point P64

Satisfaction With Intraoperative Antiemetic Treatment

Patients are asked their nausea and vomiting treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Patients are also asked their overall satisfaction with the procedure (0 = Not Satisfied, 10 = Extremely Satisfied). (NCT02960113)
Timeframe: Throughout the surgical procedure

Interventionunits on a scale (Mean)
Scopolamine Patch9.29
Acupressure Point P68.96
Scopolamine Patch + Acupressure Point P69.59

Reviews

7 reviews available for ondansetron and Complications, Pregnancy

ArticleYear
Contextualizing Potential Risks of Medications in Pregnancy for the Newborn-the Case of Ondansetron.
    JAMA pediatrics, 2020, 08-01, Volume: 174, Issue:8

    Topics: Antiemetics; Female; Humans; Infant, Newborn; Maternal Exposure; Ondansetron; Pregnancy; Pregnancy C

2020
Medications that Cause Fetal Anomalies and Possible Prevention Strategies.
    Clinics in perinatology, 2019, Volume: 46, Issue:2

    Topics: Abnormalities, Drug-Induced; Acetaminophen; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Analg

2019
Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review.
    Obstetrics and gynecology, 2016, Volume: 127, Issue:5

    Topics: Abnormalities, Drug-Induced; Antiemetics; Female; Humans; Hyperemesis Gravidarum; Infant, Newborn; O

2016
Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy: A Systematic Review.
    JAMA, 2016, 10-04, Volume: 316, Issue:13

    Topics: Acupuncture; Adrenal Cortex Hormones; Antiemetics; Doxylamine; Female; Histamine Antagonists; Humans

2016
Contemporary approaches to hyperemesis during pregnancy.
    Current opinion in obstetrics & gynecology, 2011, Volume: 23, Issue:2

    Topics: Adrenal Cortex Hormones; Antiemetics; Diet; Doxylamine; Female; Humans; Hyperemesis Gravidarum; Obst

2011
Reviewing the evidence for using continuous subcutaneous metoclopramide and ondansetron to treat nausea & vomiting during pregnancy.
    Managed care (Langhorne, Pa.), 2012, Volume: 21, Issue:5

    Topics: Antiemetics; Evidence-Based Medicine; Female; Humans; Infusions, Subcutaneous; Metoclopramide; Nause

2012
Nausea and vomiting of pregnancy.
    American family physician, 2003, Jul-01, Volume: 68, Issue:1

    Topics: Acupressure; Antiemetics; Diagnosis, Differential; Doxylamine; Female; Humans; Hyperemesis Gravidaru

2003

Other Studies

13 other studies available for ondansetron and Complications, Pregnancy

ArticleYear
Ondansetron use in nausea and vomiting during pregnancy: A descriptive analysis of prescription patterns and patient characteristics in UK general practice.
    British journal of clinical pharmacology, 2022, Volume: 88, Issue:10

    Topics: Antiemetics; Female; Folic Acid; General Practice; Humans; Nausea; Ondansetron; Pregnancy; Pregnancy

2022
Intravenous Ondansetron in Pregnancy and Risk of Congenital Malformations.
    JAMA, 2020, 01-28, Volume: 323, Issue:4

    Topics: Abnormalities, Drug-Induced; Administration, Oral; Adult; Antiemetics; Cleft Lip; Cleft Palate; Fema

2020
Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC).
    Basic & clinical pharmacology & toxicology, 2021, Volume: 128, Issue:4

    Topics: Antiemetics; Cleft Lip; Cleft Palate; Contraindications, Drug; Drug Labeling; European Union; Female

2021
Pityriasis rosea-like eruption associated with ondansetron use in pregnancy.
    British journal of clinical pharmacology, 2018, Volume: 84, Issue:5

    Topics: Adult; Antiemetics; Female; Humans; Ondansetron; Pityriasis Rosea; Pregnancy; Pregnancy Complication

2018
Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects.
    Obstetrics and gynecology, 2018, Volume: 132, Issue:2

    Topics: Abnormalities, Drug-Induced; Adult; Antiemetics; Case-Control Studies; Drug Administration Schedule;

2018
Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring.
    JAMA, 2018, 12-18, Volume: 320, Issue:23

    Topics: Abnormalities, Drug-Induced; Adult; Antiemetics; Cleft Lip; Cleft Palate; Female; Heart Defects, Con

2018
Ondansetron in pregnancy and risk of adverse fetal outcomes.
    The New England journal of medicine, 2013, Feb-28, Volume: 368, Issue:9

    Topics: Abnormalities, Drug-Induced; Abortion, Spontaneous; Adult; Antiemetics; Female; Fetus; Humans; Infan

2013
A case study approach to Hyperemesis Gravidarum: home care implications.
    Home healthcare nurse, 2009, Volume: 27, Issue:6

    Topics: Adult; Dehydration; Female; Fluid Therapy; Follow-Up Studies; Humans; Hyperemesis Gravidarum; Ondans

2009
Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects.
    Birth defects research. Part A, Clinical and molecular teratology, 2012, Volume: 94, Issue:1

    Topics: Abnormalities, Drug-Induced; Adult; Case-Control Studies; Cleft Lip; Cleft Palate; Female; Humans; H

2012
Ondansetron use during pregnancy: a case series.
    Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique, 2012, Volume: 19, Issue:1

    Topics: Adult; Antiemetics; Evidence-Based Medicine; Female; Humans; Hyperemesis Gravidarum; Ondansetron; Pr

2012
Cholestasis of pregnancy, pruritus and 5-hydroxytryptamine 3 receptor antagonists.
    Acta obstetricia et gynecologica Scandinavica, 2004, Volume: 83, Issue:9

    Topics: Cesarean Section; Cholestasis, Intrahepatic; Dose-Response Relationship, Drug; Female; Follow-Up Stu

2004
The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study.
    BJOG : an international journal of obstetrics and gynaecology, 2004, Volume: 111, Issue:9

    Topics: Adult; Analysis of Variance; Antiemetics; Female; Humans; Nausea; Ondansetron; Pregnancy; Pregnancy

2004
Ondansetron and hyperemesis gravidarum.
    Lancet (London, England), 1993, Jan-16, Volume: 341, Issue:8838

    Topics: Adult; Female; Humans; Hyperemesis Gravidarum; Nephritis; Ondansetron; Pregnancy; Pregnancy Complica

1993