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Nausea Gravidarum clinical trials

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NCT ID: NCT06059794 Completed - Anxiety Clinical Trials

Anxiety in Relation to Nausea and Vomiting in Pregnancy

Start date: January 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn more about the relation between anxiety (assessed by GAD-7 questionnaire) and the nausea and vomiting in pregnancy (objectively measured by PUQE score). Participants will answer 2 questionnaires: (GAD-7) for anxiety; and (PUQE score) for nausea and vomiting.

NCT ID: NCT05788796 Recruiting - Pregnancy Related Clinical Trials

The Effect of Band-Aid on Nausea-Vomiting During Pregnancy

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

Hormonal and physical changes during pregnancy can cause nausea and vomiting. Nausea and vomiting are common, especially in the first trimester. The incidence of nausea and vomiting during pregnancy varies between 50% and 80%. Symptoms range from mild nausea to excessive vomiting, dehydration, electrolyte imbalances, and weight loss to a severe form of nausea-vomiting called hyperemesis gravidarum (HG). Nausea-vomiting can cause discomfort in the pregnant woman in its mildest form, and a serious threat to the life of the mother and fetus in the most severe form. Nausea and vomiting during pregnancy is an important symptom that reduces the quality of life of the pregnant woman.In order to reduce the complaints of nausea and vomiting during pregnancy, women are offered suggestions such as changing their eating habits and staying away from stress. Complementary and alternative methods can also be used to reduce nausea and vomiting. Acupressure, which is one of these methods, is accepted as an important, effective, supportive and economical complementary method as a non-invasive technique that midwives can directly include in the control of nausea and vomiting during pregnancy, reducing the severity of labor pain, accelerating the birth process, gynecological problems and assisting breastfeeding. The efficacy of acupressure applied to P6, ST36 and CV8 points in cases of nausea and vomiting experienced after motion sickness, chemotherapy or surgery has been investigated in many studies. The CV8 point has not been studied sufficiently in reducing nausea and vomiting in pregnancy. Therefore, the aim of this study is to investigate the effect of a band-aid applied to the umbilical area (Shenque-CV8 point), which is a method that pregnant women can apply on their own, on nausea-vomiting during pregnancy.The sample of the study will consist of 60 pregnant women, 30 in the application group and 30 in the control group. Which of the application/control groups of the pregnant women constituting the sample group will be included will be determined by simple randomization. Pregnant women in the treatment group will be asked to fix a hazelnut-sized cotton ball to their navel with a Band-Aid regularly for five days before going to bed at night. Pregnant women in the control group will not be asked to make any life changes. Five days later, the nausea-vomiting levels of the pregnant women who applied and the pregnant women in the control group will be compared.

NCT ID: NCT05370170 Completed - Nausea Gravidarum Clinical Trials

Ottawa Nutritional Guidelines for Nausea and Vomiting

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)

NCT ID: NCT05337852 Completed - Anxiety Clinical Trials

Emotional Freedom Technique in Early Pregnancy

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

One of the most common discomforts in early pregnancy is nausea and vomiting. Although its etiology is not known exactly, it affects an average of 50-90% of pregnant women. The severity of nausea-vomiting can vary from person to person, as well as in different pregnancies of the woman. The severity of nausea-vomiting is affected by hormonal, psychological and social factors. Adaptation to pregnancy, spouse relations, future anxiety and social support perception in nausea and vomiting experienced during early pregnancy affect women negatively and cause anxiety. The severity of nausea and vomiting also increases due to anxiety. As the severity of nausea-vomiting increases, the search for solutions to this situation and their applications to health institutions increase. Many non-pharmacological methods (respiratory exercises, acupuncture, acupressure, etc.) are used in treatment, as well as hydration, rest and pharmacological agents. One of these methods is the emotional liberation technique, which is included in cognitive behavioral therapies. This method basically treats the person physiologically and psychologically as a whole, similar to other cognitive behavioral therapies, unless there is a physiological disorder. It is aimed to reach a solution by raising awareness for the emotion felt, avoiding negative emotions and focusing on affirmations to replace them. Emotional liberation technique is an easy-to-apply and fast-solving technique in cases recorded in the subconscious with negative emotions and in the treatment of stress disorders in general. No use of emotional liberation technique has been found in the literature for the severity of nausea-vomiting and anxiety experienced during early pregnancy. Therefore, it is thought that this study will contribute to the literature. In addition, it is thought that this method will enrich midwifery interventions as a non-pharmacological method applied to pregnant women in the treatment of nausea-vomiting and anxiety, because this method is fast and practical, and the result is easy to reach. The aim of this study is to determine the effect of emotional liberation technique applied during early pregnancy on nausea and vomiting severity and anxiety.

NCT ID: NCT05098067 Completed - Clinical trials for Hyperemesis Gravidarum

Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Start date: May 24, 2022
Phase: Phase 2
Study type: Interventional

Between fifty and eighty percent of pregnant women experience nausea and vomiting in pregnancy making it one of the most common medical complications of pregnancy. Hyperemesis gravidarum is an extreme form of nausea and vomiting of pregnancy and results in evidence of acute starvation (i.e. large ketonuria), and weight loss (>5% of a woman's pre-pregnancy weight). Hyperemesis gravidarum is also surprisingly common. In fact, it is the second leading cause of preterm hospitalization during pregnancy, second only preterm labor. Hospitalization is often required because hyperemesis is frequently refractory to common anti-nausea medications. However, capsaicin cream, a potent TRPV1 agonist, commonly used to relieve muscular and neuropathic pain, may be able to reduce the symptoms of nausea and emesis in patients with nausea and vomiting of pregnancy. Smaller studies have demonstrated capsaicin to be both safe and effective when used to treat intraoperative nausea during cesarean delivery. To begin to address whether capsaicin cream could be used to reduce preterm admissions and shorten emergency room visits for hyperemesis, this study will randomize women presenting to the emergency room for nausea and vomiting to treatment with capsaicin cream as an adjunctive medication or routine care. The project will investigate the impact of capsaicin cream on hospital length of stay as well as representation for additional treatment. If effective, capsaicin cream has the potential not only to reduce emergency room visits, hospital admissions and overall health care costs, but also to drastically improve patient quality of life.

NCT ID: NCT04926727 Not yet recruiting - Clinical trials for Vomiting of Pregnancy

Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

PURITY
Start date: October 4, 2021
Phase:
Study type: Observational

On February 25th, 2019, ITALFARMACO launched Nuperal® in Italy, an association of doxylamine succinate and pyridoxine hydrochloride authorized by AIFA for the symptomatic treatment of nausea and vomiting in pregnancy (NVP). This drug is also recommended as first choice drug therapy by the American College of Obstetricians and Gynecologists (ACOG) Guidelines and is supported by extensive international literature. Numerous epidemiological researches conducted in the US and Norway have highlighted the extent of vomiting and pregnant nausea. Unfortunately to date, there are no information on the prevalence of this phenomenon in Italy, on its impact on women's lives and on the interaction between woman and gynecologists. The research hypothesis of the present survey is that, using a representative sample of pregnant women in Italy, it will be possible to identify the prevalence and weight of nausea and vomiting symptoms during pregnancy in this country. The study is an open, non-comparative, multicenter survey and the aim is to evaluate the prevalence and weight that the symptoms of nausea and vomiting have in pregnant women in Italy. The study population will include 600 women found during weeks 18-22 of pregnancy who will arrive at the three sites or will contact the Investigators after the Ethics Committee (EC) approval.

NCT ID: NCT04284696 Completed - Clinical trials for Hyperemesis Gravidarum

Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum

Start date: February 11, 2020
Phase: N/A
Study type: Interventional

Nausea and vomiting is a common complication of pregnancy and occurs in 70-80% of all pregnancies. The symptoms usually start 2-4 weeks after fertilization and peak between the 9th and 16th week of gestation. In the 22nd week of pregnancy, the symptoms usually resolve. In up to 10% of all pregnancies nausea and vomiting may persist until delivery, which is called emesis gravidarum. In 0.3-2% of all pregnancies, nausea and vomiting occur with a pathological intensity called hyperemesis gravidarum. The cause of nausea and vomiting during pregnancy is unknown, but it is believed that the stimulus is the placenta and not the fetus. Antihistamines have proven to be an effective therapy. Histamine is increasingly produced during pregnancy by mast cells in the endometrium and myometrium, but also by mast cells in the placenta and in the decidua. High expression of the histamine-producing enzyme histamine-decarboxylase (HDC) in the placenta and many histamine receptors at the feto-maternal transition in the decidua indicate a physiological role of the histamine during pregnancy. The antidote is diamine oxidase (DAO), which is produced in the decidua and trophoblast and breaks down histamine. DAO acts as a barrier to prevent excessive passage of histamine into the maternal and fetal circulation. DAO levels increase exponentially in the first 20 weeks of pregnancy to 1000 times the baseline before pregnancy. It has been shown that intravenous vitamin C significantly reduces blood histamine levels in both allergic and non-allergic disorders. Another study with the German Navy also proved that oral vitamin C administration can reduce nausea in seasickness. In an Australian study in 2016, it was shown that chewing gum was not inferior to ondansetron therapy in patients with postoperative nausea and vomiting (PONV). From the available literature, we conclude that high maternal histamine concentrations in early pregnancy may be a cause of nausea and vomiting, whereas DAO is not sufficiently expressed by the transfer of histamine from the decidua and trophoblast into the maternal circulation prevent. Vitamin C has been identified in controlled clinical trials as a way to lower blood histamine levels. Furthermore, chewing gum was already described as a treatment option for nausea and vomiting. The aim of this study is therefore to test whether chewing gum containing vitamin C in pregnant women with emesis gravidarum has the potential to reduce nausea and vomiting.

NCT ID: NCT03785691 Terminated - Clinical trials for Hyperemesis Gravidarum

Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

VOMIT
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

The aim is to investigate the efficacy of mirtazapine and ondansetron as treatment for hyperemesis gravidarum(HG). The setup is a double-blind multicenter trial where patients suffering from HG will be randomized to treatment with either mirtazapine, ondansetron or placebo (1:1:1).

NCT ID: NCT03320226 Completed - Pregnancy Early Clinical Trials

A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy

Start date: January 9, 2018
Phase: N/A
Study type: Interventional

The purpose as well as the aim of this project is to understand the effect of probiotics on gastrointestinal (GI) dysfunction such as nausea, vomiting, and constipation that are found during the first and second trimesters of pregnancy. The primary objective of this project is to uncover whether probiotics have an effect on GI functional disorders. The secondary objective is to identify the microbiota associated with probiotic intake. The tested hypothesis is that gut microbiota influences the GI functions and may influence constipation, nausea, and vomiting during pregnancy.