Hyperemesis Gravidarum Clinical Trial
Official title:
Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
Verified date | November 2015 |
Source | Mustafa Kemalpasa Government Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
In this study, the investigators aimed to research the relationship between affective temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The investigators aimed to assess temperament differences between healthy pregnant women and pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.
Status | Completed |
Enrollment | 252 |
Est. completion date | July 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 41 Years |
Eligibility |
Inclusion Criteria: - To be 16 years or older - To be at the level of education to understand and answer the survey questions - To have singleton live pregnancy within the first six weeks of pregnancy according to ultrasound measurement or the level of human chorionic gonadotropine in the blood - Agreed to participate the study by signing a voluntary informed consent form Exclusion Criteria: - History of any medical problems (eg. endocrine, gastrointestinal, cardiovascular, pulmonary system diseases, vertigo) - Presence of a history of psychiatric disorder (eg. depression, anxiety, bipolar disorder, delirium, eating disorders and other psychotic disorders) - Multiple pregnancy - Pregnancy complicating situation (eg. imminent abortion, trophoblastic disease, ectopic pregnancy) - Presence of a history of regular medication use (Including drug use within the last six months for psychiatric illness) - To be not at the risk for anxiety disorder or depression according to the result of hospital anxiety and depression scale |
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Turkey | Mustafakemalpasa Government Hospital | Bursa |
Lead Sponsor | Collaborator |
---|---|
Mustafa Kemalpasa Government Hospital |
Turkey,
Bashiri A, Neumann L, Maymon E, Katz M. Hyperemesis gravidarum: epidemiologic features, complications and outcome. Eur J Obstet Gynecol Reprod Biol. 1995 Dec;63(2):135-8. — View Citation
Einarson TR, Piwko C, Koren G. Quantifying the global rates of nausea and vomiting of pregnancy: a meta analysis. J Popul Ther Clin Pharmacol. 2013;20(2):e171-83. Epub 2013 Jul 13. Review. — View Citation
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McCarthy FP, Khashan AS, North RA, Moss-Morris R, Baker PN, Dekker G, Poston L, Kenny LC; SCOPE Consortium. A prospective cohort study investigating associations between hyperemesis gravidarum and cognitive, behavioural and emotional well-being in pregnan — View Citation
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Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84. — View Citation
Weigel RM, Weigel MM. Nausea and vomiting of early pregnancy and pregnancy outcome. A meta-analytical review. Br J Obstet Gynaecol. 1989 Nov;96(11):1312-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TEMPS-A scale measurement | The participants filled out TEMPS-A survey at their first visit. | 1 day | No |
Primary | PUQE scoring index | The investigators performed this test to subjects three times of session separated by a month | 2 months | No |
Secondary | Hospital anxiety and depression scale | Used for excluding patients with the risk of anxiety disorder or depression. | 1 day | No |
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