Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial

Ostenfeld, Anne; Petersen, Tonny Studsgaard; Futtrup, Tina Bergmann; Andersen, Jón Trærup; Jensen, Andreas Kryger; Westergaard, Hanne Brix; Pedersen, Lars Henning; Løkkegaard, Ellen

doi:10.1136/bmjopen-2019-034712

Cited by 8 publications

(8 citation statements)

References 36 publications

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“…The use is approved for treatment of major depressive disorder, but might also be effective in anxiety disorders 4,5 . Additionally, mirtazapine has antiemetic effect 6 and might be an effective treatment in hyperemesis gravidarum 7–9 . Thus, knowledge of the safety of mirtazapine use in pregnancy is warranted.…”

Section: Introductionmentioning

confidence: 99%

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Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study

Ostenfeld

Petersen

Pedersen

et al. 2022

Acta Psychiatr Scand

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Objective To investigate the association between mirtazapine exposure in pregnancy and risk of specific adverse pregnancy outcomes. Methods A register‐based nationwide cohort study was conducted including all registered pregnancies in Denmark from 1997 to 2016. Mirtazapine‐exposed pregnancies were compared with mirtazapine unexposed pregnancies in a 1:4 ratio matched according to propensity scores. Outcomes were major congenital malformations analyzed using log binomial models, and spontaneous abortion, stillbirth and neonatal death analyzed using Cox proportional hazard regression. Results From a source population of 1,650,649 pregnancies, the propensity score‐matched cohort included 4475 pregnancies (895 mirtazapine exposed) in the analysis of major congenital malformations. The analyses of spontaneous abortion included 9 500 pregnancies (1900 mirtazapine exposed), and for the analyses of stillbirths and neonatal deaths 9725 (1 945 mirtazapine‐exposed) and 4485 pregnancies (897 mirtazapine‐exposed) were included, respectively. Thirty‐one (3.5%) children were diagnosed with major congenital malformation among the mirtazapine exposed compared with 152 (4.3%) among the unexposed pregnancies (OR=0.81, 95% CI 0.55–1.20). Spontaneous abortion occurred in 237 (12.5%) of the mirtazapine exposed compared with 931 (12.3%) of the unexposed pregnancies (HR = 1.04%, 95% CI 0.91–1.20). The analyses revealed no increased risk of stillbirth (HR = 0.88%, 95% CI 0.34–2.29) or neonatal death (HR = 0.60%, 95% CI 0.18–2.02). Conclusions In this nationwide Danish register study, mirtazapine exposure in pregnancy was not associated with major congenital malformations, spontaneous abortion, stillbirth, or neonatal death. Clinicians and patients can be reassured that mirtazapine is safe in pregnancy.

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Section: Introductionmentioning

confidence: 99%

“…4,5 Additionally, mirtazapine has antiemetic effect 6 and might be an effective treatment in hyperemesis gravidarum. [7][8][9] Thus, knowledge of the safety of mirtazapine use in pregnancy is warranted.…”

Section: Introductionmentioning

confidence: 99%

Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study

Ostenfeld

Petersen

Pedersen

et al. 2022

Acta Psychiatr Scand

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“…132 Yet since the publication of these systematic reviews, only one large trial of prednisolone verses placebo has been published and one RCT protocol for mirtazapine verses ondansetron and no others are currently registered with clinicaltrials.gov. 86 96 …”

Section: Discussionmentioning

confidence: 99%

“…Four of these assessed the safety of ondansetron specifically 78 80 81 84. Six were RCTs,35 36 46 49 85 86 ten were retrospective cohort studies and two were prospective cohort studies 37 38. There were also three retrospective case–control studies,87–89 two surveys90 91 and two case reports/series 92 93…”

Section: Question 4: Is Hg Preventable? What Is the Effect Of Prevent...mentioning

confidence: 99%

Systematic evidence map of evidence addressing the top 10 priority research questions for hyperemesis gravidarum

et al. 2022

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ObjectiveKnowledge gaps regarding hyperemesis gravidarum (HG) are substantial. We aimed to systematically identify and map recent evidence addressing the top 10 priority questions for HG, as published in 2021 in a James Lind Alliance Priority Setting Partnership.DesignSystematic evidence map.MethodsWe searched MEDLINE and EMBASE on 12 January 2021 and CINAHL on 22 February 2021 with search terms hyperemesis gravidarum, pernicious vomiting in pregnancy and their synonyms. Results were limited to 2009 onwards. Two reviewers independently screened titles and abstracts to assess whether the studies addressed a top 10 priority questions for HG. Differences were discussed until consensus was reached. Publications were allocated to one or more top 10 research questions. Study design was noted, as was patient or public involvement. Two reviewers extracted data synchronously and both cross-checked 10%. Extracted data were imported into EPPI-Reviewer software to create an evidence map.Outcome measuresThe number and design of studies in the search yield, displayed per the published 10 priority questions.ResultsSearches returned 4338 results for screening; 406 publications were included in the evidence map. 136 publications addressed multiple questions. Numerous studies address the immediate and long-term outcomes or possible markers for HG (question 8 and 9, respectively 164 and 82 studies). Very few studies seek a possible cure for HG (question 1, 8 studies), preventative treatment (question 4, 2 studies) or how to achieve nutritional requirements of pregnancy (question 10, 17 studies). Case reports/series were most numerous with 125 (30.7%) included. Few qualitative studies (9, 2.2%) were identified. 25 (6.1%) systematic reviews addressed eight questions, or aspects of them. 31 (7.6%) studies included patient involvement.ConclusionsThere are significant gaps and overlap in the current HG literature addressing priority questions. Researchers and funders should direct their efforts at addressing the gaps in the top 10 questions.

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“…It is of great significance to intervene in the adverse mental state of pregnant women with HG. Ostenfeld et al combined conventional drugs with psychological treatment for HG, effectively promoted the relief of pregnant women's condition [7]. McParlin et al found that psychological treatment can effectively reduce the anxiety and depression of pregnant women with HG and improve the treatment effect [8].…”

Section: Introductionmentioning

confidence: 99%

Effect of Vitamin B6 and Acupressure on Vomiting Symptoms in Pregnant Women with Hyperemesis Gravidarum

Mahmood¹,

Shah²,

Rasool³

et al. 2021

AJBLS

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Introduction: Hyperemesis Gravidarum (HG) is a common early pregnancy syndrome that usually occurs around 6 weeks of pregnancy. The patient may cause dehydration, electrolyte metabolism disorders and abnormal fat metabolism, causing increased risk of pregnancy-induced. Objective: The effects of vitamin B and acupressure application combined with psychological adjuvant therapy on vomiting symptoms and mental health in pregnant women with severe vomiting. Methods: Study Type: Randomized Control Trial Duration of Study: Twelve Months from January 2019 to December 2019 Sampling Technique: The data has been collected from the subject index coming to the gynecology OPD of Gulab Devi Teaching Hospital, Lahore, Pakistan. Control group: aged 20 to 37 years, with an average of (26.12±2.44) years; 8 to 17 weeks of gestation, with an average of (9.18±1.77) weeks. Sample Selection Inclusion Criteria: All persons who have 1) meet the diagnostic criteria for HG; 2) 20 to 40 years of age; 3) both signed informed consent. Exclusion Criteria: vomiting caused by medical diseases such as hydatidiform mole, gastrointestinal disease, viral hepatitis, cholecystitis. This study was approved by the Medical Ethics Committee of Gulab Devi Teaching hospital. Pregnant women who were enrolled were divided into control group and experimental group according to the random number table method, with 48 cases in each group. Study Tools: Questionnaire and Interview Sample size (n)=96. Results: After 7 days of treatment the effective percentage rate in the experimental group was higher as compare to the control group in terms of clinical efficacy, SAS and SDS scores, antiemetic and hospitalization time and cost was much lower and within limits in the experimental group as compare to control group. Discussion: In addition to physiological treatment such as fluid replacement, psychological treatment should not be ignored. Conclusion: vitamin B6 and acupressure application combined with psychological adjunctive treatment of HG had a significant effect and could significantly relieve pregnant women Anxiety, depression and promote the recovery of pregnant women.

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Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial

Cited by 8 publications

References 36 publications

Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study

Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study

Systematic evidence map of evidence addressing the top 10 priority research questions for hyperemesis gravidarum

Effect of Vitamin B6 and Acupressure on Vomiting Symptoms in Pregnant Women with Hyperemesis Gravidarum

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