The aim of the study is to compare medical and psychologial interventions to prevent psychiatric disordres after miscarriage. The 80 eligible women (40 persons with aborted fetus under 12 weeks and 40 persons above 12 weeks) who were18-40 years old,at least 5 years primary education, elective abortion with medical materna/fetal causes will be divided in to two experimental groups. Women with reccuent abortion, elective abortion with non-medical cause, maternal cause termination that not permited after pregnancy, sever psychiatric complications, history of nifertily will be excluded. 40 persons of experimental group 1 will be received individually medical counseling 2-hours duration by a midwife in a room in the gynecological ward. In this session will be focused on general health and next pregnancy.The experimental group 2 will be referred to a psychologist to consult the patients with grief approach. All the patients will be filled grief questionnaire and Hospital Depression anxiety scale. Also, Patients who suffered from severe psychiatric disorders will be referred to a psychiatric excluded the study. Also, patients with depression, anxiety, or unsolved grief will be invited to psychotherapy in the end of the study.
General information
Acronym
psychological interventions and miscarriage
IRCT registration information
IRCT registration number:IRCT201312255931N4
Registration date:2014-01-03, 1392/10/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
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
2014-09-23, 1393/07/01
Expected recruitment end date
2016-09-27, 1395/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of medical and psychological interventions on women's psychiatric disorders after miscarriage
Public title
The comparison effect of medical and psychological interventions on women's psychiatric disorders after miscarriage
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: pregnant women under 20 weeks; 18-40 years old; sponteneous abortion or selective abortion; at least 5 years primary education
Exclusion criteria: Reccuent abortion; elective abortion with non-medical cause; maternal cause termination with not permited next pregnancy; sever psychiatric complications; history of nifertily
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:
80
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 University of Medical Sciences, Gang Afroz street
City
Babol
Postal code
47474747
Approval date
2010-12-05, 1389/09/14
Ethics committee reference number
3461
Health conditions studied
1
Description of health condition studied
psychiatric disorder after abortion
ICD-10 code
o08.8
ICD-10 code description
Other complications following abortion and ectopic and molar pregnancy
Primary outcomes
1
Description
Depression
Timepoint
immidiately, 4 and 16 weeks after consult
Method of measurement
Hospital Depression and anxiety scale
2
Description
anxiety
Timepoint
immidiately, 4 weeks, 16 weeks after intervention
Method of measurement
Hospital Depresion Anxiety Scale
Secondary outcomes
1
Description
Grief
Timepoint
Immidiately, 4, 16, after intervention
Method of measurement
Grief Questionnaire
Intervention groups
1
Description
Experimental group1: Medical consult for 1 session (2 hours)
Category
Prevention
2
Description
Experimental group2: psychotherapy for 1 session (2 hours)
Category
Prevention
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, Gang Afroz street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Amrolah Mostafazadeh
Street address
Babol University of Medical Sciences, Gang Afroz street
City
Babol
Grant name
3461
Grant code / Reference number
3461
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Science
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 University of Medical Sciences, Gang Afroz street
City
Babol
Postal code
47474747
Phone
+98 11 1329 4453
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com
Web page address
mubabol.ac.ir
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 University of Medical Sciences, Gang Afroz street
City
Babol
Postal code
47474747
Phone
+98 11 1329 4456
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com
Web page address
mubabol.ac.ir
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 University of Medical Sciences, Gang Afroz street
City
Babol
Postal code
47474747
Phone
+98 11 1219 9595
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com
Web page address
mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)