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European Journal of Obstetrics,... Jul 2019Hyperemesis gravidarum (HG) is the main cause of hospitalization during the first trimester of pregnancy. Although it has been associated with serious complications,...
PURPOSE
Hyperemesis gravidarum (HG) is the main cause of hospitalization during the first trimester of pregnancy. Although it has been associated with serious complications, little is known about its predictive factors. The aim of this systematic review was to search for and critically appraise the studies that investigate the predictive factors for HG.
METHODS
Search strategy included PubMed, CENTRAL and EMBASE databases (till December 2017). All studies examining risk factors for HG were included. Screening of available studies was carried out by two reviewers, as well as the quality assessment of the included studies, based on the Newcastle-Ottawa Scale for observational studies.
RESULTS
The search located 308 articles, of which 14 observational studies (four low-, eight medium- and two high-quality), involving 1400 women who met the eligibility criteria. In four studies, there was no association between Helicobacter (H.) Pylori infection and HG, in contrast to two studies which demonstrated such an association. Pre-pregnancy body mass index (BMI), adipose tissue, maternal age, leptin, ghrelin, beta-chorionic gonadotropin (β-hCG), total (T) and free thyroxine (fT) correlated with HG in various studies, and could be considered as predictive markers. Regarding the high-quality evidence, a cohort study associated leptin and nephatin-1 with HG, whereas a cross-sectional study found no association between H. pylori infection and HG.
CONCLUSIONS
More studies of high quality and adequate sample size have to be carried out to identify the predictive factors for HG.
Topics: Female; Humans; Hyperemesis Gravidarum; Pregnancy
PubMed: 31126753
DOI: 10.1016/j.ejogrb.2019.04.043 -
Frontiers in Pharmacology 2020Studies have reported that patient-related factors significantly impact the risk of Chemotherapy-Induced Nausea and Vomiting (CINV). The objective of this study was to...
BACKGROUND
Studies have reported that patient-related factors significantly impact the risk of Chemotherapy-Induced Nausea and Vomiting (CINV). The objective of this study was to analyze those risk factors of CINV through a systematic literature review.
METHODS
We searched MEDLINE to identify articles that addressed patient-related risk factors of CINV through clinical studies.
RESULTS
A total of 49 articles were selected for this study. A total of 28 patient-related risk-factors that significantly impact the risk of CINV were documented. Three factors are demographically related, 17 factors are intrinsic in nature and innate to patient's physiology or influenced by physiology, and eight factors are extrinsic in nature. At least five studies identified seven risk factors with notable summary odds ratio: history of nausea/vomiting (odds ratio: 3.13, 95% CI 2.40-4.07, p < 0.05), female sex (odds ratio: 2.79, 95% CI 2.26-3.44, p < 0.05), expectancy of CINV (odds ratio: 2.61, 95%CI 1.69-4.02, p < 0.05), younger age (odds ratio: 2.59, 95% CI 2.18-3.07, p < 0.05), anxiety (odds ratio: 2.57, 95% CI 1.94-3.40, p < 0.05), history of morning sickness (odds ratio: 1.97, 95% CI 1.46-2.65, p < 0.05), and low alcohol intake (odds ratio: 1.94, 95% CI 1.68-2.24, p < 0.05).
CONCLUSIONS
Oncologists can use these factors prior to the initiation of a chemotherapy regimen to identify patients at risk for CINV, in order to focus on more comprehensive antiemetic treatment options for those high-risk patients. This may enable better outcomes and avoid complications.
PubMed: 32296333
DOI: 10.3389/fphar.2020.00329 -
European Journal of Obstetrics,... May 2019Pregnant women have an increased demand for thiamine. In hyperemesis gravidarum (HG) thiamine rapidly depletes, which can lead to Wernicke's Encephalopathy (WE). Our...
Pregnant women have an increased demand for thiamine. In hyperemesis gravidarum (HG) thiamine rapidly depletes, which can lead to Wernicke's Encephalopathy (WE). Our objective was to systematically review the signs and symptoms of WE in HG. We conducted our search from inception using Mesh terms hyperemesis, Wernicke Encephalopathy, Korsakoff's syndrome, and pregnancy. We searched Pubmed, Embase, Cochrane, Web of Science, Psychinfo, PiCarta, and Cinahl. We defined WE as mental, oculomotor, and motoric alterations and thiamine deficiency; HG was defined as severe nausea, and vomiting during pregnancy; adequate WE treatment as >500 mg/day intramuscular or intravenous. Our search yielded 146 case studies reporting on 177 cases. Pregnant WE patients became thiamine depleted between 10-15 weeks of gestation. Patients had been vomiting for a median of 7 weeks before WE, and had lost 12.1 kg. Prodromal signs of WE were nausea and vomiting (100%), double vision (37.4%), and blurred vision (27.4%). Treatment with subtherapeutic thiamin dose was common (63.6%), WE was exacerbated by intravenous glucose administration (14.1%). We found chronic cognitive disorders occurred in 65.4%, pregnancy loss in 50%, and maternal death in 5% of cases. Thiamine supplementation was insufficient or absent from treatment plans. To eradicate WE in pregnancy, it is necessary to give 100 mg of intravenous or intramuscular thiamine in HG patients with persistent or severe late onset vomiting to prevent them from developing WE.
Topics: Female; Humans; Hyperemesis Gravidarum; Pregnancy; Thiamine; Vitamin B Complex; Wernicke Encephalopathy
PubMed: 30889425
DOI: 10.1016/j.ejogrb.2019.03.006 -
European Journal of Obstetrics,... Feb 2021Hyperemesis gravidarum (HG) is characterised by extreme nausea and vomiting of pregnancy, which can lead to dehydration, weight loss and electrolyte disturbances....
Hyperemesis gravidarum (HG) is characterised by extreme nausea and vomiting of pregnancy, which can lead to dehydration, weight loss and electrolyte disturbances. Historically research has been challenging due to a lack of diagnostic criteria and objective outcome measures. Most studies in this population group have focused on medical management of symptoms, with little known about the effect of HG on nutritional intake and how this relates to perinatal outcomes. The aim of this study was to synthesise current knowledge of the dietary intake of women with HG. A systematic search of search engines was conducted in April 2020 using the following databases: MEDLINE, Embase, CINAHL, Cochrane database, Scopus, NHS Evidence, BNI, Emcare, ClinicalTrials.gov, PROSPERO, Ethos and Open Grey. Titles and abstracts were screened independently by two reviewers against predefined inclusion and exclusion criteria. Studies were included where the authors described severe pregnancy nausea and vomiting as HG, regardless of how HG was defined. After removal of duplicates, 4402 titles were identified, of which 3992 were initially excluded based on abstract and title. Following full text review, four of 10 articles were included. Three of the studies were hospital-based case control studies, one was an observational women's cohort study. Assessment of dietary intake was heterogeneous, with both retrospective and prospective self-report methods used, over different timeframes. In three of the studies, dietary intake was reported at one time point only. In total, across all four studies, data from only 314 women were included. Overall, despite data collected from four different countries, over 30 years, with various methods, women with HG had a significantly poorer dietary intake compared to non-affected pregnant women, consuming less than 50 % of recommended intakes for most nutrients. Nutritional intake worsened with increasing severity of symptoms. As this was a scoping review, study quality was not assessed. Overall, this review has identified a paucity of data about the dietary intake of women with HG; the limited available data indicates that women with HG are at risk of malnutrition. Future research quantifying nutritional intake in women with HG at several time points during pregnancy would provide valuable reference data, enabling nutritional status and outcomes to be monitored and interventions to be evaluated.
Topics: Cohort Studies; Eating; Female; Humans; Hyperemesis Gravidarum; Pregnancy; Prospective Studies; Retrospective Studies
PubMed: 33360613
DOI: 10.1016/j.ejogrb.2020.12.003 -
Australian Journal of General Practice Oct 2022Nausea, vomiting and hyperemesis in early pregnancy are common in primary care, and hospital care is required in severe cases. The aim of this review is to appraise...
BACKGROUND AND OBJECTIVES
Nausea, vomiting and hyperemesis in early pregnancy are common in primary care, and hospital care is required in severe cases. The aim of this review is to appraise relevant clinical practice guidelines (CPGs) to manage hyperemesis gravidarum (HG) by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) checklist.
METHOD
A systematic search was conducted employing PubMed, Cochrane and ScienceDirect from inception until May 2021. The quality of four CPGs were evaluated by two appraisers independently using the AGREE II checklist.
RESULTS
Four international CPGs that fulfilled the criteria were included in this review; all scored over 50% according to the AGREE II tool. Applying a modified categorisation standard, CPGs were considered as either 'recommended' or 'recommended with modifications'.
DISCUSSION
The synthesis of all four CPGs suggested similar management strategies for HG, with minor differences. Medical practitioners could use the guiding principles of management on the basis of the needs of individual patients.
Topics: Female; Humans; Hyperemesis Gravidarum; Practice Guidelines as Topic; Pregnancy
PubMed: 36184858
DOI: 10.31128/AJGP-01-22-6288 -
The Cochrane Database of Systematic... Oct 2018Progesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. It has... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Progesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. It has been suggested that a causative factor in many cases of miscarriage may be inadequate secretion of progesterone. Therefore, clinicians use progestogens (drugs that interact with the progesterone receptors), beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage. This is an update of a review, last published in 2013.
OBJECTIVES
To assess the efficacy and safety of progestogens as a preventative therapy against recurrent miscarriage.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (6 July 2017) and reference lists from relevant articles, attempting to contact trial authors where necessary, and contacted experts in the field for unpublished works.
SELECTION CRITERIA
Randomized or quasi-randomized controlled trials comparing progestogens with placebo or no treatment given in an effort to prevent miscarriage.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two reviewers assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
Thirteen trials (2556 women) met the inclusion criteria. Nine of the included trials compared treatment with placebo and the remaining four trials compared progestogen administration with no treatment. The trials were a mix of multicenter and single-center trials, conducted in Egypt, India, Jordan, UK and USA. In six trials women had had three or more consecutive miscarriages and in seven trials women had suffered two or more consecutive miscarriages. Routes, dosage and duration of progestogen treatment varied across the trials. The majority of trials were at low risk of bias for most domains. Eleven trials (2359 women) contributed data to the analyses.The meta-analysis of all women, suggests that there is probably a reduction in the number of miscarriages for women given progestogen supplementation compared to placebo/controls (average risk ratio (RR) 0.69, 95% confidence interval (CI) 0.51 to 0.92, 11 trials, 2359 women, moderate-quality evidence). A subgroup analysis comparing placebo-controlled versus non-placebo-controlled trials and different routes of administration showed no differences between subgroups for miscarriage. However, there appears to be a subgroup difference for miscarriage between women with three or more prior miscarriages compared to women with two or more miscarriages, with a more pronounced effect in women with three or more prior miscarriages. However, it should be noted that there was high heterogeneity in the subgroup of women with three or more prior miscarriages.None of the trials reported on any secondary maternal outcomes, including severity of morning sickness, thromboembolic events, depression, admission to a special care unit, or subsequent fertility.There was probably a slight benefit for women receiving progestogen seen in the outcome of live birth rate (RR 1.11, 95% CI 1.00 to 1.24, 7 trials, 2086 women, moderate-quality evidence). While the rate of preterm birth is probably reduced for women receiving progestogen, this outcome was mainly driven by one trial and thus should be interpreted with great caution (RR 0.59, 95% CI 0.39 to 0.89, 5 trials, 811 women, moderate-quality evidence). No clear differences were seen for women receiving progestogen for the other secondary outcomes of neonatal death or fetal genital abnormalities. A possible reduction in stillbirth was seen, but again this outcome was driven mainly by one trial and should be interpreted with caution (RR 0.38, 95% CI 0.24 to 0.58, 3 trials, 1199 women). There may be little or no difference in the rate of low birthweight and trials did not report on the secondary child outcomes of teratogenic effects or admission to a special care unit.
AUTHORS' CONCLUSIONS
For women with unexplained recurrent miscarriages, supplementation with progestogen therapy probably reduces the rate of miscarriage in subsequent pregnancies.
Topics: Abortion, Habitual; Abortion, Spontaneous; Female; Humans; Live Birth; Placebos; Pregnancy; Pregnancy Trimester, Second; Premature Birth; Progestins; Randomized Controlled Trials as Topic
PubMed: 30298541
DOI: 10.1002/14651858.CD003511.pub4 -
BJOG : An International Journal of... Nov 2018Hyperemesis gravidarum (HG) is a common cause of hospital admission in early pregnancy. There is no international consensus on the definition of HG, or on outcomes that...
BACKGROUND
Hyperemesis gravidarum (HG) is a common cause of hospital admission in early pregnancy. There is no international consensus on the definition of HG, or on outcomes that should be reported in trials. Consistency in definition and outcome reporting is important for the interpretation and synthesis of data in meta-analyses.
OBJECTIVE
To identify which HG definitions and outcomes are currently in use in trials.
SEARCH STRATEGY
We searched the following sources: (1) Cochrane Central Register of Controlled Trials, (2) Embase and (3) Medline for published trials and the WHO-ICTRP database for ongoing trials (27 October 2017).
SELECTION CRITERIA
All randomised clinical trials reporting on any intervention for HG were eligible.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed trial eligibility and extracted data on HG definition and outcomes.
MAIN RESULTS
We included 31 published trials reporting data from 2511 women and three ongoing trials with a planned sample size of 360 participants. We identified 11 definition items. Most commonly used definition items were vomiting (34 trials) and nausea (30 trials). We identified 34 distinct outcomes. Most commonly reported outcomes were vomiting (29 trials), nausea (26 trials), need for hospital treatment (14 trials) and duration of hospital (re)admission(s) (14 trials).
CONCLUSION
There is substantial variation of HG definition and outcome reporting in trials. This hampers meaningful aggregation of trial results in meta-analysis and implementation of evidence in guidelines. To overcome this, international consensus on a definition and a core outcome set for HG trials should be developed.
TWEETABLE ABSTRACT
There is a wide variation of definitions and outcomes reported in trials on hyperemesis gravidarum.
Topics: Female; Humans; Hyperemesis Gravidarum; Outcome Assessment, Health Care; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic
PubMed: 29727913
DOI: 10.1111/1471-0528.15272 -
BJOG : An International Journal of... Jul 2020To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).
OBJECTIVE
To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG).
DESIGN
Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round.
SETTING
An international web-based survey combined with a consensus development meeting.
POPULATION
Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals.
METHODS
We used systematic review, semi-structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web-based survey rounds, followed by a face-to-face consensus development meeting and a web-based consultation round.
MAIN OUTCOME MEASURES
A core outcome set for research on HG.
RESULTS
Fifty-six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short- and long-term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death).
CONCLUSIONS
This core outcome set will help standardise outcome reporting in HG trials.
TWEETABLE ABSTRACT
A core outcome set for treatment of hyperemesis gravidarum in order to create high-quality evidence.
Topics: Adult; Antiemetics; Biomedical Research; Consensus; Delphi Technique; Female; Humans; Hyperemesis Gravidarum; Maternal Health; Pregnancy; Prenatal Care; Quality of Life; Research Design
PubMed: 32056342
DOI: 10.1111/1471-0528.16172 -
The Cochrane Database of Systematic... Nov 2019Progesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. It has... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Progesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. It has been suggested that a causative factor in many cases of miscarriage may be inadequate secretion of progesterone. Therefore, clinicians use progestogens (drugs that interact with the progesterone receptors), beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage. This is an update of a review, last published in 2013. Since publication of the 2018 update of this review, we have been advised that the Ismail 2017 study is currently the subject of an investigation by the Journal of Maternal-Fetal & Neonatal Medicine. We have now moved this study from 'included studies' to 'Characteristics of studies awaiting classification' until the outcome of the investigation is known.
OBJECTIVES
To assess the efficacy and safety of progestogens as a preventative therapy against recurrent miscarriage.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (6 July 2017) and reference lists from relevant articles, attempting to contact trial authors where necessary, and contacted experts in the field for unpublished works.
SELECTION CRITERIA
Randomized or quasi-randomized controlled trials comparing progestogens with placebo or no treatment given in an effort to prevent miscarriage.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two reviewers assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
Twelve trials (1,856 women) met the inclusion criteria. Eight of the included trials compared treatment with placebo and the remaining four trials compared progestogen administration with no treatment. The trials were a mix of multicenter and single-center trials, conducted in India, Jordan, UK and USA. In five trials women had had three or more consecutive miscarriages and in seven trials women had suffered two or more consecutive miscarriages. Routes, dosage and duration of progestogen treatment varied across the trials. The majority of trials were at low risk of bias for most domains. Ten trials (1684 women) contributed data to the analyses. The meta-analysis of all women, suggests that there may be a reduction in the number of miscarriages for women given progestogen supplementation compared to placebo/controls (average risk ratio (RR) 0.73, 95% confidence interval (CI) 0.54 to 1.00, 10 trials, 1684 women, moderate-quality evidence). A subgroup analysis comparing placebo-controlled versus non-placebo-controlled trials, trials of women with three or more prior miscarriages compared to women with two or more miscarriages and different routes of administration showed no clear differences between subgroups for miscarriage. None of the trials reported on any secondary maternal outcomes, including severity of morning sickness, thromboembolic events, depression, admission to a special care unit, or subsequent fertility. There was probably a slight benefit for women receiving progestogen seen in the outcome of live birth rate (RR 1.07, 95% CI 1.00 to 1.13, 6 trials, 1411 women, moderate-quality evidence). We are uncertain about the effect on the rate of preterm birth because the evidence is very low-quality (RR 1.13, 95% CI 0.53 to 2.41, 4 trials, 256 women, very low-quality evidence). No clear differences were seen for women receiving progestogen for the other secondary outcomes including neonatal death, fetal genital abnormalities or stillbirth. There may be little or no difference in the rate of low birthweight and trials did not report on the secondary child outcomes of teratogenic effects or admission to a special care unit.
AUTHORS' CONCLUSIONS
For women with unexplained recurrent miscarriages, supplementation with progestogen therapy may reduce the rate of miscarriage in subsequent pregnancies.
Topics: Abortion, Habitual; Abortion, Spontaneous; Female; Humans; Pregnancy; Pregnancy Trimester, First; Pregnancy Trimester, Second; Premature Birth; Progesterone; Progestins; Randomized Controlled Trials as Topic
PubMed: 31745982
DOI: 10.1002/14651858.CD003511.pub5 -
American Journal of Perinatology Sep 2014Antihistamines are commonly used to treat nausea and vomiting of pregnancy (NVP). We re-analyzed the 24 primary studies cited in a 1997 meta-analysis that concluded... (Meta-Analysis)
Meta-Analysis
Antihistamines are commonly used to treat nausea and vomiting of pregnancy (NVP). We re-analyzed the 24 primary studies cited in a 1997 meta-analysis that concluded antihistamine use for NVP was safe as they had been studied in more than 200,000 participating women and the pooled odds ratio for congenital malformations was 0.76 (95% confidence interval [CI]: 0.60-0.94). Our analysis of this meta-analysis showed that 139,414 women were included in 22 original studies involving antihistamines, 129,108 of which were in studies involving doxylamine. In these studies, 23,485 women were exposed to antihistamines, 14,624 of which were exposed to doxylamine. The summary relative risk (cohort studies) and odds ratio (case-control studies) for congenital malformations from antihistamine exposure were 1.09 (95% CI: 1.01-1.18) and 1.04 (95% CI: 0.91-1.19), and for doxylamine exposure, the summary relative risk and odds ratio were 0.94 (95% CI: 0.80-1.10) and 1.07 (95% CI: 0.93-1.23), respectively. Although not a new systematic review, our re-analysis demonstrates that the safety data for antihistamines, and doxylamine in particular, are based on many fewer than 200,000 participating women and exposures, and that doxylamine use is not associated with a decreased risk of malformations as previously reported.
Topics: Antiemetics; Congenital Abnormalities; Doxylamine; Female; Humans; Morning Sickness; Odds Ratio; Pregnancy; Risk
PubMed: 24323370
DOI: 10.1055/s-0033-1358772