NCT02541682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

November 23, 2015

Status Verified

November 1, 2015

Enrollment Period

2.1 years

First QC Date

August 30, 2015

Last Update Submit

November 20, 2015

Conditions

Hyperemesis GravidarumTemperamentMorning Sickness

Outcome Measures

Primary Outcomes (2)

  • TEMPS-A scale measurement

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

    1 day

  • PUQE scoring index

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

    2 months

Secondary Outcomes (1)

  • Hospital anxiety and depression scale

    1 day

Study Arms (4)

Control

OTHER

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)

Mild nausea and vomiting of pregnancy

OTHER

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)

Moderate nausea and vomiting of pregnancy

OTHER

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)

Severe nausea and vomiting of pregnancy

OTHER

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)

Interventions

TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)OTHER

Participants filled out the TEMPS-A survey at their first visit.

ControlMild nausea and vomiting of pregnancyModerate nausea and vomiting of pregnancySevere nausea and vomiting of pregnancy

Eligibility Criteria

Age16 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafakemalpasa Government Hospital

Bursa, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 16006438RESULT

  • 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.

    PMID: 8373648RESULT

  • 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.

    PMID: 23863575RESULT

  • 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.

    PMID: 8903768RESULT

  • 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.

    PMID: 16449112RESULT

  • 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.

    PMID: 18500939RESULT

  • 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.

    PMID: 2611170RESULT

  • Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84.

    PMID: 22866186RESULT

  • 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.

    PMID: 22125621RESULT

MeSH Terms

Conditions

Hyperemesis GravidarumMorning Sickness

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ALI BAHADIRLI, M.D.

    Recruiting

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

August 30, 2015

First Posted

September 4, 2015

Study Start

March 1, 2013

Primary Completion

April 1, 2015

Study Completion

July 1, 2015

Last Updated

November 23, 2015

Record last verified: 2015-11

Locations

TU(1)