Clinical trial NCT02541682: Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
Official title: Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperemesis Gravidarum
Temperament
Morning Sickness
Lead sponsor: Mustafa Kemalpasa Government Hospital
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 252
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 41
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: TEMPS-A scale measurement
timeFrame: 1 day
measure: PUQE scoring index
timeFrame: 2 months
Secondary outcomes:
measure: Hospital anxiety and depression scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Mustafakemalpasa Government Hospital
Study officials:
affiliation: Recruiting
name: ALI BAHADIRLI, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verberg MF, Gillott DJ, Al-Fardan N, Grudzinskas JG. Hyperemesis gravidarum, a literature review. Hum Reprod Update. 2005 Sep-Oct;11(5):527-39. doi: 10.1093/humupd/dmi021. Epub 2005 Jul 8.
citation: Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract. 1993 Jun;43(371):245-8.
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.
citation: 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. doi: 10.1016/0301-2115(95)02238-4.
citation: Fell DB, Dodds L, Joseph KS, Allen VM, Butler B. Risk factors for hyperemesis gravidarum requiring hospital admission during pregnancy. Obstet Gynecol. 2006 Feb;107(2 Pt 1):277-84. doi: 10.1097/01.AOG.0000195059.82029.74.
citation: Flaxman SM, Sherman PW. Morning sickness: adaptive cause or nonadaptive consequence of embryo viability? Am Nat. 2008 Jul;172(1):54-62. doi: 10.1086/588081.
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. doi: 10.1111/j.1471-0528.1989.tb03229.x.
citation: Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84.
citation: 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 pregnancy. PLoS One. 2011;6(11):e27678. doi: 10.1371/journal.pone.0027678. Epub 2011 Nov 18.