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

Primary Purpose

Hyperemesis Gravidarum, Temperament, Morning Sickness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Sponsored by
Mustafa Kemalpasa Government Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hyperemesis Gravidarum

Eligibility Criteria

16 Years - 41 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mustafakemalpasa Government Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Control

Mild nausea and vomiting of pregnancy

Moderate nausea and vomiting of pregnancy

Severe nausea and vomiting of pregnancy

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

TEMPS-A scale measurement
The participants filled out TEMPS-A survey at their first visit.
PUQE scoring index
The investigators performed this test to subjects three times of session separated by a month

Secondary Outcome Measures

Hospital anxiety and depression scale
Used for excluding patients with the risk of anxiety disorder or depression.

Full Information

First Posted
August 30, 2015
Last Updated
November 20, 2015
Sponsor
Mustafa Kemalpasa Government Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02541682
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemalpasa Government Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemesis Gravidarum, Temperament, Morning Sickness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
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.
Arm Title
Mild nausea and vomiting of pregnancy
Arm Type
Other
Arm Description
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.
Arm Title
Moderate nausea and vomiting of pregnancy
Arm Type
Other
Arm Description
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.
Arm Title
Severe nausea and vomiting of pregnancy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Intervention Description
Participants filled out the TEMPS-A survey at their first visit.
Primary Outcome Measure Information:
Title
TEMPS-A scale measurement
Description
The participants filled out TEMPS-A survey at their first visit.
Time Frame
1 day
Title
PUQE scoring index
Description
The investigators performed this test to subjects three times of session separated by a month
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Hospital anxiety and depression scale
Description
Used for excluding patients with the risk of anxiety disorder or depression.
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALI BAHADIRLI, M.D.
Organizational Affiliation
Recruiting
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mustafakemalpasa Government Hospital
City
Bursa
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16006438
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. Erratum In: Hum Reprod Update. 2007 Mar-Apr;13(2):207.
Results Reference
result
PubMed Identifier
8373648
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.
Results Reference
result
PubMed Identifier
23863575
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.
Results Reference
result
PubMed Identifier
8903768
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.
Results Reference
result
PubMed Identifier
16449112
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.
Results Reference
result
PubMed Identifier
18500939
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.
Results Reference
result
PubMed Identifier
2611170
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.
Results Reference
result
PubMed Identifier
22866186
Citation
Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84.
Results Reference
result
PubMed Identifier
22125621
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.
Results Reference
result

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

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