Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
NCT ID: NCT02541682
Last Updated: 2015-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
252 participants
INTERVENTIONAL
2013-03-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Control
Participants who have PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 3 and showing no symptom of nausea and/or vomiting during the three control visits. Control visits are performed a month apart.
TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Mild nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 4-6 during the three control visits. Control visits are performed a month apart.
TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Moderate nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 7-12 during the three control visits. Control visits are performed a month apart.
TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Severe nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 13-15 during the three control visits. Control visits are performed a month apart.
TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Interventions
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TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
41 Years
FEMALE
Yes
Sponsors
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Mustafa Kemalpasa Government Hospital
OTHER
Responsible Party
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ALI BAHADIRLI
Specialist
Principal Investigators
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ALI BAHADIRLI, M.D.
Role: PRINCIPAL_INVESTIGATOR
Recruiting
Locations
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Mustafakemalpasa Government Hospital
Bursa, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84.
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.
Other Identifiers
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TUTF-GOKAEK 2013/50
Identifier Type: -
Identifier Source: org_study_id