Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy

Hyperemesis Gravidarum Clinical Trial

Official title:

Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541682
• Other study ID #: TUTF-GOKAEK 2013/50
• Status: Completed
• Phase: N/A
• First received: August 30, 2015
• Last updated: November 20, 2015
• Start date: March 2013
• Est. completion date: July 2015

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hyperemesis Gravidarum
• Morning Sickness
• Temperament

Intervention

Other:
• TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.

Locations

Country	Name	City	State
Turkey	Mustafakemalpasa Government Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemalpasa Government Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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

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. — View 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. — View 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. Erratum in: Br J Gen Pract 1993 Aug;43(373):325. — View 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 pregnan — View 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. Epub 2005 Jul 8. Review. Erratum in: Hum Reprod Update. 2007 Mar-Apr;13(2):207. — View Citation

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

Outcome

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