Pregnancy Unique Quantification Of Emesis Score Research Articles

Validation of Sinhala and Tamil translations of the motherisk: Pregnancy unique quantification of emesis (PUQE) scoring system

Aims: Nausea and vomiting in pregnancy (NVP), where there are no other underlying causes, is one of the most common symptoms in the early part of the pregnancy. It is responsible for up to 80% of pregnant population. By using PUQE score system, it is very convenient to categorize pregnant women with nausea and vomiting come to outpatient department (OPD) or general practice into those who can manage in community setting or those who need inpatient treatments. Objectives: Validation of PUQE instrument to assess NVP and hyperemesis gravidarum (HG) women in Sri Lanka. Methods: Descriptive cross-sectional study conducted among 160 pregnant women presented to the Gynecology Unit of Teaching Hospital Anuradhapura (ATH) during three months duration. Translated self-administered PUQE questionnaire was applied to the patients with signs and symptoms with emesis in pregnancy. All study participants were undergoing clinical judgment as a confirmation test. Diagnostic test accuracy methods were used to assess criterion validity of the experimental tool. Data were analyzed by using SPSS statistical software version 25.0. Results: Study population has a mean age of 27.96 (SD 5.31). Majority of study participants were Sinhalese and according to the parity majority were primigravida pregnancies. Majority of study participants were diagnosed as NVP Stage II (N=134:53.8%) by the PUQE scoring system. According to the clinical judgment Stage II of NVP was diagnosed among 127 (79.4%) study participants. Mean score of the PUQE scale was 9.08 (SD=2.35). Reliability assessment of the PUQE scoring system was reported as an excellent level (Cronbach alpha=0.804). Five types of management strategies were detected among study participants. Significantly high percentage of study participants were given first line antiemetics and oral rehydration solutions. Calculated sensitivity of the PUQE scoring system to diagnose Stage I of NVP was 69.56% and specificity was 96.35%. Calculated sensitivity of the PUQE scoring system to diagnose Stage II of NVP was 100% and specificity was 78.78%. All pregnant women who were clinically detected as Stage II NVP patients were detected as Stage II NVP patients by the PUQE scoring system also. None of the false positives and false negatives regarding Stage II of NVP detected by the PUQE scoring system. Conclusion: First line antiemetics and oral rehydration solutions are usually used for treating pregnancy-related nausea and vomiting. Stage II NVP conditions were detected with a higher prevalence when NVP status was diagnosed clinically and with PUQE scoring system. Specificity of PUQE scoring system appeared higher while detecting NVP Stage I and for NVP Stage II, sensitivity of PUQE scoring system appeared high. For Stage III NVP, clinical judgments and PUQE scoring system values were completely compatible. Management strategies used for treating pregnancy-related hyperemesis status should be further studied. Conducting these studies at different study settings may help to achieve more successful results. Pregnancy unique quantification of emesis tool can be used to diagnose NVP status more descriptively. Also, this PUQE tool is a valid tool which can be effectively used for patient management. Application of PUQE scoring system should be published by planning and implementing staff awareness programs for both curative sector and public health sector.

Association of the 24-hour Pregnancy Unique Quantification of Emesis Index with Self-Rated Wellbeing Score: A Cross-Sectional Study

Introduction: Nausea and Vomiting of Pregnancy (NVP) are common symptoms of pregnancy. Often, treatment is guided by subjective symptoms, leading to hospitalisation of these patients and unnecessary health costs. The 24-hour Pregnancy-Unique Quantification of Emesis (PUQE) index helps objectively quantify these symptoms and guide the management of these patients. Aim: To assess the association of the 24-hour PUQE index with the self-rated well-being score in evaluating the severity of NVP. Materials and Methods: In this cross-sectional study, a total of 207 women at 5 to 12 weeks of singleton pregnancy were recruited after obtaining informed consent. They were interviewed regarding their symptoms of nausea and vomiting based on a 24-hour PUQE index questionnaire, and a score was assigned to them. They were stratified as mild, moderate, or severe based on the score. The association of these symptoms with a selfrated well-being score and subjective symptoms such as the ability to take multivitamins, sleep pattern, liquid intake, and the need for hospitalisation was assessed. They were followed-up after four weeks, and a repeat score was obtained. Chi-square test was performed to compare the severity of PUQE-24. Results: The mean well-being score at the first visit was 3.381±1.650, and at the follow-up visit, it was 7±1.763. At the first visit, 46 out of 207 had a mild 24-hour PUQE score, 140 out of 207 had a moderate score, and 21 out of 207 had a severe score. During the follow-up visit, 123 out of 207 had a mild score, 77 out of 207 had a moderate score, and seven out of 207 had a severe score. There was a significant association between the mean self-rated well-being score and the 24-hour PUQE score at the first and follow-up visits (p-value=0.0001). Among the patients hospitalised at the first visit (21 out of 28), 75% belonged to the severe PUQE category. The mean liquid intake at the first visit was 24.363±10.357 mL/kg/hr, and at the followup visit was 29.972±10.691, showing a significant association with the severity of the 24-hour PUQE score (p-value=0.0001). A significant association was observed between the 24-hour PUQE scores of the first and follow-up visits (p-value=0.002). Conclusion: In this study, there was a significant association between the 24-hour PUQE score and the well-being score at both visits. Stratifying the severity of NVP objectively will guide us to choose the appropriate treatment and reduce the need for hospitalisation.

Waterpipe Tobacco (Hookah) Use in Pregnancy: Associations with Nausea and Vomiting of Pregnancy.

Waterpipe tobacco (WPT) use is common among reproductive age patients and is often perceived as safer than cigarette use. Prior studies have shown a decrease in nausea and vomiting symptoms among pregnant women who use cigarettes, but no studies to date have examined these symptoms in pregnant women who use WPT. This study was aimed to investigate the extent of symptoms of nausea/vomiting of pregnancy among participants who self-reported WPT use during pregnancy. Secondary analysis of a prospective cohort study examining WPT use during pregnancy. Participants completed the Pregnancy-Unique Quantification of Emesis (PUQE) during first and third trimesters. Medical conditions were determined by medical record review. Participants were evaluated by sole WPT use versus dual/polysubstance WPT use and frequency of WPT use. Ninety-nine (100%) participants completed the PUQE questionnaire during first trimester and 82 (82.8%) completed the PUQE during third trimester. Almost all (91.9%) participants reported moderate nausea/vomiting symptoms at both assessments. There was no difference in frequency of WPT use in pregnancy or rates of dual/polysubstance WPT use in participants with all levels of the PUQE questionnaire. There was also no difference in rates of WPT use or PUQE scores between sole WPT users and dual/polysubstance users. When comparing low and high WPT use, those who were in the higher frequency use group had higher waterpipe dependence scale scores (7.2 vs. 5.3, p < 0.02). With regard to maternal medical comorbidities, the only difference between groups was that sole WPT users were more likely to have a diagnosis of asthma than dual/polysubstance users (36.8 vs. 14.9%, p < 0.02). There were no differences in symptoms of nausea and vomiting of pregnancy or medical conditions in pregnant women who use WPT with any frequency during pregnancy. However, sole WPT users had higher rates of asthma than dual/polysubstance WPT users. · Waterpipe tobacco use is one of the most common forms of tobacco use among reproductive age patients.. · Waterpipe tobacco use was not associated with any changes in nausea/vomiting of pregnancy symptoms.. · Future research on the use of waterpipe tobacco in pregnancy can aid in public health responses..

Nausea and vomiting of pregnancy beyond the first trimester and the risk of preterm birth

Although most pregnant persons with nausea and vomiting of pregnancy (NVP) have symptoms that improve after the first trimester, approximately 20% experience NVP later in gestation. Little is known about pregnancy outcomes among these individuals. We aimed to investigate pregnancy outcomes among those with NVP after the first trimester. This is a secondary analysis of 9117 nulliparas from the NuMoM2b cohort who underwent NVP assessment with the Pregnancy-Unique Quantification of Emesis (PUQE) scale at three study visits; “V1” at 12.5±2.7 weeks, “V2” at 19.4±2.5 weeks, and “V3” at 28.0±3.2 weeks. Scores ranged 3-15 and were classified as having no NVP symptoms (PUQE score=3), mild (4-6) or moderate/severe (≥ 7) NVP at each visit. Chi-square analyses were used to compare the rate of adverse pregnancy outcomes (APO); small for gestational age, gestational hypertension, stillbirth, gestational diabetes, preterm birth (PTB) < 34 weeks, PTB < 37 weeks, across NVP categories at each study visit. Separate logistic regression models were used to estimate the association between degree of NVP at each visit and the odds of PTB < 37 weeks – adjusted for covariates (age, body mass index, race/ethnicity, smoking, gestational hypertension, depression). A separate sensitivity analysis was performed with additional adjustment for rate of gestational weight gain (GWG) per week. Degree of NVP at V1 and V3 was not associated with APO. There was a higher rate of PTB < 37 weeks in those with mild (10.1%) and moderate/severe NVP (13.3% ) versus having no NVP (8.2%) in V2 (χ2=13.8, p=0.001) (Table 1). On adjusted analysis, there was a marginally higher odds of PTB < 37 weeks among those with mild NVP at V2 (OR 1.21, 95% CI 1.00 to 1.47, p=0.050) and significantly higher odds with moderate/severe NVP at V2 (OR 1.60, 95% CI 1.09 to 2.36, p=0.017) versus having no NVP. This relationship was strengthened after adding GWG as a covariate (OR 1.85, 95% CI: 1.20 to 2.86, p=0.005). Moderate/severe NVP in mid-gestation may be associated with a higher risk of PTB.

Recalling the severity of nausea and vomiting of pregnancy – a study using Pregnancy-Unique Quantification of Emesis Questionnaire

The accuracy of the recall of the severity of nausea and vomiting of pregnancy (NVP) with Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire has been questioned. We aimed to compare PUQE scores of women recalling the worst episode of NVP of their current pregnancy in different gestational weeks (gwks). Total of 2343 pregnant women (gwks 7–40) were recruited. Four groups were formed according to the gwks at reply: ≤16 gwks (n = 554), ≤20 gwks (n = 1209), >20 gwks (n = 1134) and ≥24 gwks (n = 495). PUQE scores were similar between the groups. Consequently, consistency of PUQE scores across the groups endorses the useability of the PUQE questionnaire in retrospective assessment of the overall severity of NVP in different gwks, regardless of passing of the peak NVP symptoms. Impact statement What is already known on this subject? Retrospective evaluation of the severity of nausea and vomiting of pregnancy (NVP) has been argued to be disposed to recall bias. Structured Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire is a validated tool for assessing the severity of NVP. What do the results of this study add? When the women recalled the most severe NVP symptoms of their current pregnancy, no differences in the PUQE scores were found despite different gestational weeks at reply. Of distinct PUQE questions, women answering in early pregnancy reported longer duration of nausea than women answering in late pregnancy, but other questions were rated similarly. What the implications are of these findings for clinical practice and/or further research? Our aim was to compare the PUQE scores between the women who filled in the PUQE questionnaire in early or in late pregnancy, instructed to recall their worst symptoms in their current pregnancy. As there were no differences between the groups in total PUQE scores, our results support the application of PUQE questionnaire to assess the severity of NVP during pregnancy not only concurrent to the peak symptoms but also retrospectively.

Impact of a Mobile Application for Tracking Nausea and Vomiting During Pregnancy (NVP) on NVP Symptoms, Quality of Life, and Decisional Conflict Regarding NVP Treatments: MinSafeStart Randomized Controlled Trial.

BackgroundPregnant women are active users of mobile apps for health purposes. These apps may improve self-management of health-related conditions. Up to 70% of pregnant women experience nausea and vomiting (NVP). Even mild NVP can significantly reduce quality of life (QoL), and it can become an economic burden for both the woman and society. NVP often occurs before the first maternal care visit; therefore, apps can potentially play an important role in empowering pregnant women to recognize, manage, and seek appropriate treatment for NVP, when required.ObjectiveThis study investigated whether the MinSafeStart (MSS) mobile app could impact NVP-related symptoms, QoL, and decisional conflict regarding NVP treatment.MethodsThis randomized controlled trial enrolled 268 pregnant women with NVP in Norway from 2019 to 2020. The intervention group had access to the MSS app, which could be used to track NVP symptoms and access tailored advice. NVP severity was rated with the Pregnancy Unique Quantification of Emesis (PUQE) score. The control group followed standard maternal care. We collected data on maternal baseline characteristics, NVP severity, QoL, and decisional conflict using 2 sets of online questionnaires. One set of questionnaires was completed at enrollment, and the other was completed after 2 weeks. We performed linear regression analyses to explore whether the use of the MSS app was associated with NVP severity, QoL, or decisional conflict.ResultsAmong the 268 women enrolled in the study, 192 (86.5%) completed the baseline questionnaires and were randomized to either the intervention (n=89) or control group (n=103). In the intervention group, 88 women downloaded the app, and 468 logs were recorded. In both groups, women were enrolled at a median of 8 gestational weeks. At baseline, the average PUQE scores were 4.9 and 4.7; the average QoL scores were 146 and 149; and the average DCS scores were 40 and 43 in the intervention and control groups, respectively. The app had no impact on NVP severity (aβ 0.6, 95% Cl −0.1 to 1.2), QoL (aβ −5.3, 95% Cl −12.5 to 1.9), or decisional conflict regarding NVP treatment (aβ −1.1, 95% Cl −6.2 to 4.2), compared with standard care.ConclusionsTracking NVP symptoms with the MSS app was not associated with improvements in NVP symptoms, QoL, or decisional conflict after 2 weeks, compared with standard care. Future studies should include a process evaluation to improve our understanding of how pregnant women use the app and how to optimize its utility within maternity care. Specifically, studies should focus on how digital tools might facilitate counseling and communication between pregnant women and health care providers regarding NVP management during pregnancy.Trial RegistrationClinicalTrails.gov (NCT04719286): https://www.clinicaltrials.gov/ct2/show/NCT04719286

Evaluation of plasma cholecystokinin levels and gallbladder functions in hyperemesis gravidarum: a prospective cohort study

This is a prospective cohort study aimed to compare women treated due to hyperemesis gravidarum (HG) (n = 24) to women with normal pregnancy attending regular antenatal outpatient care (n = 22) in terms of fasting and post-prandial cholecystokinin (CCK) levels, and gallbladder (GB) functions. The Pregnancy-Unique Quantification of Emesis (PUQE) scores, fasting and postprandial CCK levels, and ultrasonographic GB parameters were recorded at admission before any treatment. The median PUQE score in the study group was 8. There were no statistically significant differences in GB parameters (p>.05), and fasting and postprandial CCK levels between the groups (p=.851, p=.395, respectively). Fasting CCK levels were positively correlated with postprandial GB volume (PGv) (p=.022, r = 0.464). Although GB contractility is compromised during pregnancy, HG does not cause further GB impairment. The positive correlation between fasting CCK levels and PGv requires further evaluation. Impact Statement What is already known on this subject? The pathophysiology of hyperemesis gravidarum (HG) remains poorly understood. Altered cholecystokinin (CCK) levels may have potential consequences on gastric emptying, which may be related to nausea and vomiting. In this context, alterations in CCK secretion in women diagnosed with HG have been previously reported, and alterations in CCK levels lead to impaired gallbladder (GB) functions. What do the results of this study add? CCK levels and GB functions in pregnant women with HG are not statistically significantly different from those in healthy pregnant women. What are the implications of these findings for clinical practice and/or further research? Further studies designed in patients with different severities of HG and larger sample sizes are required for a better understanding of HG pathophysiology.

Evaluation of Nausea and Vomiting Severity in Pregnancies Conceived Through Assisted Reproduction

OBJECTIVE: This study aimed to evaluate the severity of nausea vomiting of pregnancy in assisted reproductive technologies pregnancies using the Pregnancy-Unique Quantification of Emesis scoring system which is a validated, clinically relevant method to assess nausea vomiting of pregnancy severity. STUDY DESİGN: A total of 101 pregnant women between 8+0-14+6 weeks of gestation were enrolled in this case-control study. Of these women, 53 had pregnancies conceived via assisted reproductive technologies (study group) and 48 had pregnancies conceived naturally (control group). The Pregnancy-Unique Quantification of Emesis-24 scale was utilized to evaluate nausea vomiting of pregnancy severity in both groups. Weight change during pregnancy and hospital admission due to nausea vomiting of pregnancy were also compared to assess severe nausea vomiting of pregnancy. RESULTS: According to the Pregnancy-Unique Quantification of Emesis scale, 67.9% of patients with assisted reproductive technologies pregnancies experienced mild nausea vomiting of pregnancy while 24.5% had moderate and 7.5% had severe nausea vomiting of pregnancy. In the spontaneous pregnancies group, 60.4% experienced mild nausea vomiting of pregnancy, 33.3% had moderate nausea vomiting of pregnancy and only 6.3% had severe nausea vomiting of pregnancy. The overall Pregnancy-Unique Quantification of Emesis score was 5 (3-8.5) in assisted reproductive technologies pregnancies and 5 (3-10) in spontaneous pregnancies (p=0.650). There was no statistically significant difference regarding hospitalization history due to nausea vomiting of pregnancy between assisted reproductive technologies and naturally-conceived pregnancies (p=0.619). CONCLUSION: Conception using assisted reproductive technologies does not increase nausea vomiting of pregnancy severity. Furthermore, weight change during pregnancy and hospitalization rates due to nausea vomiting of pregnancy were comparable between women conceived with assisted reproductive technologies and women with natural conception.

Comparison of the effectiveness of ondansetron versus metoclopramide in hyperemesis gravidarum: a randomized clinical trial

Objective: Nausea and vomiting are the most common complications and the first cause of hospitalization of pregnant women in the first trimester of pregnancy. Given the maternal and fetal complications as well as the negative psychosocial and economic effects of nausea and vomiting, the present study aimed to compare the antiemetic effects of ondansetron and metoclopramide.&#x0D; Methods: The present double-blind randomized clinical trial study was conducted on 153 pregnant women with a complaint of nausea and vomiting during pregnancy referred to the obstetrics and gynecology ward. Patients were randomly divided into two metoclopramide and ondansetron groups. The outcomes of interest were nausea and vomiting, the number of used doses of the drug, and the length of hospital stay. The Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire was used to assess the severity of nausea and vomiting.&#x0D; Results: The mean age was significantly higher in the metoclopramide group (28.44±6.45 vs. 25.43±5.42 years, P=0.004). On day 3, the PUQE score was significantly higher in the ondansetron group (6.60±1.10 vs. 6.56±0.88, P&lt;0.001). The decrease in the severity of nausea and vomiting was significantly higher in the ondansetron group (5.29±1.35 vs. 4.90±1.17, P=0.05) in the second day compared to the first day. In the repeated measure analysis, significant differences were found between the two treatment groups (F=7.01, P=0.009). There was no significant difference between the two groups in terms of the length of hospital stay (P&gt;0.05).&#x0D; Conclusion: In this study, ondansetron revealed more efficacy than metoclopramide on the nausea and vomiting of pregnancy (NVP) management. Ondansetron may, therefore, be considered as a safe and effective alternative for metoclopramide in the treatment of NVP.

Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomised control trial with patient preference arm

ObjectiveTo determine whether ambulatory (outpatient (OP)) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care.DesignNon-blinded randomised control trial (RCT) with patient preference arm.SettingTwo...

Plasma serotonin levels are elevated in pregnant women with hyperemesis gravidarum.

This study aimed to determine the association between serotonin and hyperemesis gravidarum. Plasma samples of 87 women in their first trimester pregnancies with HG (n = 28), morning sickness of pregnancy (n = 30) and control (n = 29) groups were obtained. Plasma levels of serotonin were compared between the groups, and the correlations with severity of symptoms using modified PUQE (Pregnancy Unique Quantification of Emesis) scoring, BMI, E2, hCG and TSH were calculated. When the groups were compared with respect to serotonin levels, the group with hyperemesis gravidarum was found to have significantly higher serotonin levels (p = 0.001). A significant positive correlation was found between the serotonin level and the PUQE score in all study subjects (r = 0.578, p = 0.0001). A serotonin threshold of >277.58 ng/mL had a sensitivity of 75%, specificity of 86.4%, positive predictive value of 72.4%, negative predictive value of 87.9%, and a likelihood ratio of 5.53 (p = 0.0001). Our findings support the possible role of serotonin in the pathogenesis of hyperemesis gravidarum.

Transdermal clonidine in the treatment of severe hyperemesis. A pilot randomised control trial: CLONEMESI

To study the efficacy of transdermal clonidine in the treatment of severe refractory hyperemesis gravidarum (HG), the most severe illness of pregnancy. The study had a randomised, double -blind, placebo-controlled, cross-over design (RCT). Single tertiary referral hospital after admission of patients. Twelve women of gestational age 6-12 weeks and a major grade of HG clinical severity who were unresponsive to standard antiemetic treatment. The patients were randomly treated with and without the active drug (5 mg patch) for two consecutive periods of 5 days. The patients were allocated to a random list to receive first placebo and then active drug or the other way round. Other antiemetic drugs were administered on a scheduled or as-needed basis. All patients received intravenous hydration and thiamine supplementation. Pregnancy Unique Quantification of Emesis (PUQE) and visual analog scale (VAS) clinical scores, positive morning urine ketonuria, number of doses of standard antiemetic drugs required, and number of days off intravenous therapy were compared in the two periods. Transdermal clonidine led to a significantly greater improvement compared with placebo of the primary (PUQE score P = 0.026 CI 0.43-3.24; VAS score P = 0.010 CI 2.17-12.83) and secondary outcome measures. A reduction of blood pressure was reported for systolic 6 mmHg P = 0.01 and diastolic 3 mmHg P = 0.055. This preliminary RCT demonstrates the efficacy of transdermal clonidine in the treatment of severe HG, leading to a significant reduction of symptoms and reducing the need for other supportive measures and medications.

Pharmacogenetic predictors of nausea and vomiting of pregnancy severity and response to antiemetic therapy: a pilot study

BackgroundNausea and vomiting of pregnancy (NVP) is a common condition. The objective of this study was to evaluate the association between response to antiemetics in the treatment of NVP and genetic polymorphisms in the serotonin receptor subunit genes HTR3A and HTR3B.MethodsPregnant women ≥18 years of age with NVP starting antiemetic therapy with promethazine, prochlorperazine, metoclopramide, or ondansetron at ≤ 16 weeks gestational age were eligible. The study recruited 29 women with complete data and sampling who returned for their one week follow-up and were genotyped for HTR3A and HTR3B polymorphisms. Severity of NVP was captured (using Pregnancy Unique Quantification of Emesis (PUQE) and Quality of Life (QOL) tools) upon enrollment and after one week of antiemetic therapy. These measures were correlated with pharmacogenetic variability.ResultsSubjects with genotype associated with high serotonin affinity of the 5-HT3B receptor (rs1176744, CC) required more antiemetic medications (p < 0.001) than other subjects. Those with genotypes associated with increased expression of the 5-HT3A receptor subunit (rs1062613, CT or TT) had worse final PUQE scores (p = 0.01) than other subjects while rs3782025 variants carriers had significantly better initial (p = 0.02) and final (p = 0.02) PUQE scores than other subjects.ConclusionsHTR3B and HTR3A gene variants may contribute to variability in response to antiemetic therapy for NVP.

Ghrelin, acylated ghrelin, leptin and PYY-3 levels in hyperemesis gravidarum

Objective: To assess the serum levels of gut and adipocyte-derived metabolic hormones that control appetite, adipocity, weight gain and energy hemostasis, namely total ghrelin (TG), acylated ghrelin (AG), leptin and PYY-3 in hyperemesis gravidarum (HG).Methods: Plasma samples of 86 women in their first trimester pregnancies with HG (n = 30), morning sickness of pregnancy (MSP) (n = 34) and control (n = 22) groups were obtained. Serum levels of TG, AG, leptin and PYY-3 were compared between the groups, and the correlations with severity of symptoms using modified PUQE (Pregnancy Unique Quantification of Emesis) scoring, BMI, E2, hCG and TSH were calculated.Results: Levels of TG, AG, PYY-3 and the TG/leptin ratio were significantly higher in HG group compared to MSP and the control groups (p ≤ 0.017). AG/TG ratio was significantly lower in the HG group compared to both MSP and control groups (p ≤ 0.017). There were either weak or no significant statistical correlations between the gut and adipose-related hormones and the modified PUQE scores, BMI, E2, hCG and TSH.Conclusion: Gut-derived metabolic hormones ghrelin, AG and PYY-3 may be involved in the HG pathophysiology.

Determinants of Adherence to Delayed-Release Doxylamine and Pyridoxine in Patients With Nausea and Vomiting of Pregnancy

Women often hesitate to take medications in pregnancy due to fears of perceived potential fetal damage. The authors' objective is to identify the determinants of adherence to delayed-release doxylamine-pyridoxine (Diclectin) in patients with nausea and vomiting of pregnancy (NVP). The authors performed a prespecified secondary analysis of a multicenter double-blind randomized controlled trial of Diclectin versus placebo for the treatment of NVP. Data on adherence to study medication were collected in all patients. The primary outcome of this analysis was adherence to study medication, which was determined by pill counting and patient diaries. The treatment regimen in the original trial was not fixed and depended on patient's symptoms. There was no difference in the adherence rates between subjects in the Diclectin or placebo arms of the study, so the 2 arms were analyzed as one cohort. The degree of adherence was analyzed in the various subgroups. Subsequently, a multiple linear regression model was constructed to identify predictors to adherence. Two hundred fifty-eight women were included in this analysis. There were no differences in adherence rates according to ethnicity, race, or the presence of adverse events. Gravidity, average number of prescribed tablets per day, site of enrollment, and change in NVP severity measured by the pregnancy unique-quantification of emesis score were associated with adherence. In multivariable analysis, average number of tablets per day, change in pregnancy unique-quantification of emesis, number of treatment days, site of enrollment were significantly predictive of adherence, with the former being negatively correlated. Adherence to antinauseants for NVP is affected by number of tablets prescribed per day, and treatment duration and effectiveness.

A novel approach to hyperemesis gravidarum: evaluation by a visual analogue scale score and treatment with transdermal clonidine.

A preliminary report on the symptomatic effect of clonidine in severe hyperemesis gravidarum (HG). Observational. Hospital based: Ospedale Sant'Anna, Torino, Italy. Twelve pregnant women, 8-16 weeks, affected by severe, refractory HG. Assessment by two clinical score indexes: Pregnancy Unique Quantification of Emesis (PUQE) score and a Visual Analogue Scale (VAS) 5-item questionnaire, filled out daily, to detect subjective improvement or worsening of symptoms. PUQE score and VAS score before and after transdermal clonidine treatment. We found substantial improvement of symptoms and severity score indexes after four and 14 days. The comparison of pretreatment and post-treatment scores shows a significant statistical difference P < 0.0001. Transdermal clonidine may be considered as a treatment for resistant severe HG.

Treatment of Severe Nausea and Vomiting of Pregnancy with Subcutaneous Medications

We examined treatment outcomes in women with severe nausea and vomiting of pregnancy (NVP) receiving outpatient nursing support and either subcutaneous metoclopramide or subcutaneous ondansetron via a microinfusion pump. Among women receiving outpatient nursing services, we identified those diagnosed with severe NVP having a Pregnancy-Unique Quantification of Emesis (PUQE) score of greater than 12 at enrollment and prescribed either metoclopramide (N = 355) or ondansetron (N = 521) by their physician. Maternal characteristics, response to treatment, and start versus stop values were compared between the medication groups. Allocation to group was based on intention-to-treat protocol. Maternal characteristics were similar between the groups. Days to reduction in PUQE score levels were similar (median 2 days, metoclopramide; 3 days, ondansetron; P = 0.206). Alteration from metoclopramide to ondansetron (31.8%) was more frequent than alteration from ondansetron to metoclopramide (4.4%; P < 0.001). Improvement of NVP symptoms and reduced need for hospitalization was noted with both medications. Treatment with either metoclopramide or ondansetron resulted in significant improvement of NVP symptoms with half of women showing a reduction from severe symptoms to moderate or mild symptoms within 3 days of treatment initiation. Alteration in treatment was significantly greater in patients initially prescribed metoclopramide.