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

• Sponsor: Mustafa Kemalpasa Government Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02541682
• Collaborator: (none)
• Enrollment: 252
• Location: 1
• Arms: 4
• Duration (Months): 28
• Patients Per Site Per Month: 9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperemesis Gravidarum; Temperament; Morning Sickness	Other: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 252 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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.
Other: 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.	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.
Other: 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.	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.
Other: 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.	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.

Outcome Measures

Primary Outcome Measures

1. TEMPS-A scale measurement [1 day]

   The participants filled out TEMPS-A survey at their first visit.

2. PUQE scoring index [2 months]

   The investigators performed this test to subjects three times of session separated by a month

Secondary Outcome Measures

1. Hospital anxiety and depression scale [1 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 41 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mustafakemalpasa Government Hospital	Bursa		Turkey

Sponsors and Collaborators

• Mustafa Kemalpasa Government Hospital

Investigators

• Principal Investigator: ALI BAHADIRLI, M.D., Recruiting

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ALI BAHADIRLI, Specialist, Mustafa Kemalpasa Government Hospital
• ClinicalTrials.gov Identifier: NCT02541682
• Other Study ID Numbers: TUTF-GOKAEK 2013/50
• First Posted: Sep 4, 2015
• Last Update Posted: Nov 23, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Hyperemesis Gravidarum; Morning Sickness; Vomiting

Study Results

No Results Posted as of Nov 23, 2015