Ondansetron Compared With Metoclopramide for Hyperemesis Gravidarum

Abas, Mohamed Norazam; Tan, Peng Chiong; Azmi, Noor; Omar, Siti Zawiah

doi:10.1097/aog.0000000000000242

Cited by 74 publications

(88 citation statements)

References 22 publications

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“…Additional UKTIS data on promethazine are reported in Appendix 7. 57,72,75,81,105 and one cohort study 121 compared the serotonin antagonist (ondansetron) against a range of alternatives for the treatment of women experiencing various severities of nausea in pregnancy. Of these, one study focussed on the safety of ondansetron versus the usual treatment regimen, 121 with symptom severity not specified.…”

Section: Safety Outcomesmentioning

confidence: 99%

“…57,60,61,63,64,66,67,73,76,78,[80][81][82][83][84][85]88,89,93,98,99,102,103,[105][106][107][108]112,118 Thirty studies did not provide sufficient information to allow a judgement of low or high risk and were therefore classed as unclear. 13,[41][42][43]58,59,62,65,[68][69][70][71]74,75,77,79,90,91,[94][95][96][97]100,…”

Section: Allocation Concealmentmentioning

confidence: 99%

“…Of the included RCT studies, 32 were judged to have low risk of bias in relation to the blinding of participants and other personnel involved in the trial, 41,57,[59][60][61][62][63][64]67,71,72,74,79,[81][82][83][84][85]90,93,99,100,102,103,105,106,108,110,112,113,116,117 generally through the provision of medication in identical formats for both active and placebo. Sixteen studies were judged to have high risk of bias in this respect, for example due to clear differences in either the appearance, dosage rates or mode of delivery between intervention and placebo comparator, or as a result of evidence that the research staff involved were aware of allocation status.…”

Section: Allocation Concealmentmentioning

confidence: 99%

“…13,41,42,61,62,64,67,70,71,74,81,83,88,96,[101][102][103]106,110,112 However, a substantial number (n = 44) were classed as unclear, due to lack of sufficient information in the paper to permit detailed assessment of whether or not an important risk of bias existed, or due to insufficient rationale or evidence that an identified problem had introduced serious levels of bias to the study. 43,[57][58][59][60]65,66,68,69,72,73,[75][76][77][78][79][80]82,84,85,87,[89][90][91][92][93][94][95][97]…”

Section: Allocation Concealmentmentioning

confidence: 99%

“…13,41,57,60,[62][63][64]66,67,69,70,76,[80][81][82][83][85][86][87][88][89]91,93,94,[98][99][100][101][102][103][104][106][107][108]110,[112][113][114][115] Methods employed included random number tables, computer-generated sequence generation 61,63,64,[81][82][83]88,93,94,98,99,106,108,…”

Section: Random Sequence Generationmentioning

confidence: 99%

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Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

O’Donnell

McParlin

Robson

et al. 2016

Health Technol Assess

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BackgroundNausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are more severe and the most severe form of NVP – hyperemesis gravidarum (HG) – affects 0.3–1.0% of pregnant women. There is no widely accepted point at which NVP becomes HG.ObjectivesThis study aimed to determine the relative clinical effectiveness and cost-effectiveness of treatments for NVP and HG.Data sourcesMEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, PsycINFO, Commonwealth Agricultural Bureaux (CAB) Abstracts, Latin American and Caribbean Health Sciences Literature, Allied and Complementary Medicine Database, British Nursing Index, Science Citation Index, Social Sciences Citation Index, Scopus, Conference Proceedings Index, NHS Economic Evaluation Database, Health Economic Evaluations Database, China National Knowledge Infrastructure, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects were searched from inception to September 2014. References from studies and literature reviews identified were also examined.Obstetric Medicinewas hand-searched, as were websites of relevant organisations. Costs came from NHS sources.Review methodsA systematic review of randomised and non-randomised controlled trials (RCTs) for effectiveness, and population-based case series for adverse events and fetal outcomes. Treatments: vitamins B6 and B12, ginger, acupressure/acupuncture, hypnotherapy, antiemetics, dopamine antagonists, 5-hydroxytryptamine receptor antagonists, intravenous (i.v.) fluids, corticosteroids, enteral and parenteral feeding or other novel treatment. Two reviewers extracted data and quality assessed studies. Results were narratively synthesised; planned meta-analysis was not possible due to heterogeneity and incomplete reporting. A simple economic evaluation considered the implied values of treatments.ResultsSeventy-three studies (75 reports) met the inclusion criteria. For RCTs, 33 and 11 studies had a low and high risk of bias respectively. For the remainder (n = 20) it was unclear. The non-randomised studies (n = 9) were low quality. There were 33 separate comparators. The most common were acupressure versus placebo (n = 12); steroid versus usual treatment (n = 7); ginger versus placebo (n = 6); ginger versus vitamin B6 (n = 6); and vitamin B6 versus placebo (n = 4). There was evidence that ginger, antihistamines, metoclopramide (mild disease) and vitamin B6 (mild to severe disease) are better than placebo. Diclectin®[Duchesnay Inc.; doxylamine succinate (10 mg) plus pyridoxine hydrochloride (10 mg) slow release tablet] is more effective than placebo and ondansetron is more effective at reducing nausea than pyridoxine plus doxylamine. Diclectin before symptoms of NVP begin for women at high risk of severe NVP recurrence reduces risk of moderate/severe NVP compared with taking Diclectin once symptoms begin. Promethazine is as, and ondansetron is more, effective than metoclopramide for severe NVP/HG. I.v. fluids help correct dehydration and improve symptoms. Dextrose saline may be more effective at reducing nausea than normal saline. Transdermal clonidine patches may be effective for severe HG. Enteral feeding is effective but extreme method treatment for very severe symptoms. Day case management for moderate/severe symptoms is feasible, acceptable and as effective as inpatient care. For all other interventions and comparisons, evidence is unclear. The economic analysis was limited by lack of effectiveness data, but comparison of costs between treatments highlights the implications of different choices.LimitationsThe main limitations were the quantity and quality of the data available.ConclusionThere was evidence of some improvement in symptoms for some treatments, but these data may not be transferable across disease severities. Methodologically sound and larger trials of the main therapies considered within the UK NHS are needed.Study registrationThis study is registered as PROSPERO CRD42013006642.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Safety Outcomesmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Random Sequence Generationmentioning

confidence: 99%

See 3 more Smart Citations

Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

O’Donnell

McParlin

Robson

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

show abstract

Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy

McParlin

O’Donnell

Robson

et al. 2016

JAMA

135

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Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring

Huybrechts

Hernández–Dı́az

Straub

et al. 2018

JAMA

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Importance: Evidence for the fetal safety of ondansetron, a 5-HT3 receptor antagonist that is commonly prescribed for nausea and vomiting in pregnancy, is limited and conflicting. Objective: To evaluate the association between ondansetron exposure during pregnancy and risk of congenital malformations. Design, Setting, and Participants: A retrospective cohort study nested in the 2000–2013 nationwide Medicaid Analytic eXtract. The cohort consisted of 1,816,414 pregnancies contributed by 1,502,895 women enrolled in Medicaid from 3 months before the last menstrual period through ≥1 month after delivery; infants were enrolled in Medicaid for ≥3 months after birth. The final date of follow-up was December 31, 2013. Propensity score stratification was used to control for treatment indication and other confounders. Exposure: Ondansetron dispensing during the first trimester, the period of organogenesis. Main Outcome(s) and Measure(s): Primary outcomes were cardiac malformations and oral clefts diagnosed during the first 90 days after delivery. Secondary outcomes included congenital malformations overall and subgroups of cardiac malformations and oral clefts. Results: Among 1,816,414 pregnancies (mean age, 24.3 [5.8] years), 88,467 (4.9%) were exposed to ondansetron during the first trimester. Overall, 14,577 of 1,727,947 unexposed and 835 of 88,467 exposed infants were diagnosed with a cardiac malformation, for an absolute risk of 84.4 (95% CI, 83.0 – 85.7) and 94.4 (88.0 – 100.8) per 10,000 births respectively. The absolute risks of oral clefts were 11.1 (10.6 – 11.6) and 14.0 (11.6 – 16.5) per 10,000 (1,912 unexposed and 124 exposed cases); and the risks of any congenital malformation were 370.4 (358.0 – 382.9) and 313.5 (310.9 – 316.1) per 10,000 (3,277 exposed and 54,174 unexposed cases). The adjusted relative risk (RR) for cardiac malformations was 0.99 (95% CI, 0.93 – 1.06) and the adjusted risk difference (RD) was −0.8 (−7.3 – 5.7 per 10,000 births). For oral clefts, the adjusted RR was 1.24 (1.03 – 1.48) and the RD was 2.7 (0.2 – 5.2 per 10,000 births). The adjusted estimate for congenital malformations overall was RR = 1.01 (0.98 – 1.05) and RD = 5.4 (−7.3 – 18.2 per 10,000 births). Conclusions and Relevance: Among offspring of mothers enrolled in Medicaid, first-trimester exposure to ondansetron was not associated with cardiac malformations or congenital malformations overall after accounting for measured confounders, but was associated with a small increased risk of oral clefts.

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Ondansetron Compared With Metoclopramide for Hyperemesis Gravidarum

Abstract: I.

Cited by 74 publications

References 22 publications

Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

Treatments for hyperemesis gravidarum and nausea and vomiting in pregnancy: a systematic review and economic assessment

Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy

Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring

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