Hyperemesis in Pregnancy Study: a pilot randomised controlled trial of midwife-led outpatient care

McParlin, Catherine; Carrick-Sen, Debbie; Steen, Ian Nicholas; Robson, Stephen C.

doi:10.1016/j.ejogrb.2016.02.016

Cited by 26 publications

(26 citation statements)

References 35 publications

(33 reference statements)

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“…In the trial of McParlin and colleagues, 88 the effectiveness of the same treatments (i.v. cyclizine and i.v.…”

Section: Pregnancy-unique Quantification Of Emesis and Nausea Scalementioning

confidence: 99%

“…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. 13,58,66,68,75,77,78,80,[87][88][89]91,92,96,101,115 In some instances, however, despite lack of blinding, the nature of the intervention meant that this was not relevant; for example, in McParlin and colleagues 88 where blinding of participants and staff was not possible as the packages of care delivered to the intervention and control groups varied in content. However, it is important to highlight that although it might not have been possible to blind patients or clinicians, outcome assessors and analysts handling the resultant data may nevertheless have been blinded.…”

Section: Allocation Concealmentmentioning

confidence: 99%

“…42,58,68,69,73,77,79,82,95,100,105,109,111 Other sources of bias Twenty of the included RCT studies were judged as having low risk of bias in this area. 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]…”

Section: Allocation Concealmentmentioning

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%

“…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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“…In the trial of McParlin and colleagues, 88 the effectiveness of the same treatments (i.v. cyclizine and i.v.…”

Section: Pregnancy-unique Quantification Of Emesis and Nausea Scalementioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

Section: Allocation Concealmentmentioning

confidence: 99%

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

Self Cite

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Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy

McParlin

O’Donnell

Robson

et al. 2016

JAMA

131

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Readmissions due to hyperemesis gravidarum: a nation-wide Finnish register study

Nurmi

Rautava

Gissler

et al. 2022

Arch Gynecol Obstet

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Purpose To evaluate the burden of illness caused by hyperemesis gravidarum (HG) and association of readmissions due to HG with maternal, environmental and pregnancy-related factors, and different pregnancy outcomes. Methods Data of women with HG diagnosis in Finland, 2005–2017, were retrieved from health-care registers. Associations between readmissions due to HG and age, gravidity, parity, pre-pregnancy body mass index (BMI), smoking, marital status, socioeconomic status, municipality population, assisted reproductive technology (ART), and number and sex of fetuses were analyzed in pregnancies resulting in delivery. Admissions and readmissions due to HG in deliveries, gestational trophoblastic disease, ectopic pregnancies, miscarriages and pregnancy terminations were calculated. Results 10,381 pregnancies with HG diagnosis were identified: 9518 live births, 31 stillbirths, 8 cases of gestational trophoblastic disease, 16 ectopic pregnancies, 299 miscarriages, and 509 pregnancy terminations. Both outpatients and inpatients were included. Readmission occurred in 60% of pregnancies, inpatient readmission in 17%. Parity of ≥ 5, multiple gestation and female sex of fetus were associated with higher odds of readmission, maternal age 36–40 years, BMI ≥ 35 kg/m2, smoking and ART with lower odds of readmission. Of the 9549 pregnancies resulting in delivery, 33% involved at least one outpatient visit or inpatient episode after the first trimester, and 8% in the third trimester. Conclusion The majority of women suffering from HG needed repeated medical care, often persisting after the first trimester. Our results provide practical information allowing clinicians to prepare for symptom duration beyond the first trimester and emphasize the importance of planning for eventual long-term treatment.

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Hyperemesis in Pregnancy Study: a pilot randomised controlled trial of midwife-led outpatient care

Abstract: This study suggests that day-case management plus ongoing midwifery support may be an effective alternative for treating women with severe NVP/HG. A larger trial is needed to determine if this intervention affects women's QoL.

Cited by 26 publications

References 35 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

Readmissions due to hyperemesis gravidarum: a nation-wide Finnish register study

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