In a randomized clinical trial 86 pregnant women above 18 years, singleton, first trimester with moderate nausea / vomiting and inform consent to enter the study will be selected. Women will be assigned randomly to two groups; either control (pharmacotherapy alone) or experimental (pharmacotherapy plus psychotherapy) group. Pharmacotherapy group will be give pyridoxine hydrochloride (40 mg daily) for 3 weeks. Experimental group will receive pyridoxine hydrochloride (40 mg daily) and psychotherapy in eight individual sessions over 3 weeks. All participants will completed the Rodeshes index of nausea, vomiting and retching (RINVR), the hospital anxiety and depression scale (HADS), and prenatal distress questionnaire (PDQ) at baseline, 3 weeks after baseline, and at 1 month post-treatment follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304035931N2
Registration date:2013-04-16, 1392/01/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-16, 1392/01/27
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2013-02-01, 1391/11/13
Expected recruitment end date
2014-12-23, 1393/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of psychotherapy and pharmacotherapy to improvement of nausea and vomiting of pregnancy
Public title
The comparison of effectiveness of psychotherapy and pharmacotherapy to improvement of nausea and vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age above 18 years; singleton pregnancy and first trimester.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol- Gang Afroz
City
Babol
Postal code
4715864247
Approval date
2013-01-22, 1391/11/03
Ethics committee reference number
2006
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
Naesea/vomiting
Timepoint
Beginning of the study and after 4 weeks
Method of measurement
Rodesh scale
Secondary outcomes
1
Description
anxiety and depression
Timepoint
beginning, after 3 weeks, 1 month follow-up
Method of measurement
hospital anxiety and depression scale (HADS)
Intervention groups
1
Description
This group will be given pyridoxine hydrochloride (40 mg daily) for 3 weeks.
Category
Treatment - Drugs
2
Description
Group psycotherapy , will be given treatment session 1 hour weekly for 3 weeks
Category
Treatment - Other
3
Description
Control group do not recieve any intervention except routin notritional nausea/vomoting.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani hospital
Full name of responsible person
Mahbobeh faramarzi
Street address
Babol University of Medical sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
ِDr Mostafazadeh
Street address
Babol University of Medical Sciences
City
babol
Grant name
پژوهشی
Grant code / Reference number
2006
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Assistant professor
Other areas of specialty/work
Street address
Babol-Babol University of Medical Sciences
City
Babol
Postal code
47158644247
Phone
+98 11 1329 4456
Fax
Email
mahbob330@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Assistant professor
Other areas of specialty/work
Street address
Babol-Babol University of Medical Sciences
City
Babol
Postal code
47158644247
Phone
+98 11 1329 4456
Fax
Email
mahbob330@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Assistant professor
Other areas of specialty/work
Street address
Babol- Babol University of Medical Sciences
City
Babol
Postal code
47158644247
Phone
+98 11 1329 4456
Fax
Email
mahbob330@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)