Comparison of the average score of pregnancy experiences between the two intervention and control groups
Design
A randomized clinical trial will be conducted on 60 women with unplanned pregnancies. The participants will be entered into two intervention and control groups by random block method with blocks of four and six with allocation ratio of 1:1.
Settings and conduct
The research population includes all pregnant mothers with unplanned pregnancies, who refer to Tabriz health centers for prenatal care in 1403. At this stage, sampling of mothers Qualified to participate in the present study will be done in the available method, then complete explanations in The subject of research, its goals and the method of its implementation will be left at the disposal of women. In case of desire to participate in the study, written informed consent will be obtained from the women and The participants will be provided with sufficient assurance regarding the confidentiality of the information obtained. In this study, pregnancy experience will be measured as the primary outcome and depression, anxiety, violence and attachment of the mother to the fetus and premature birth will be measured as secondary outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Women with unplanned pregnancy
2. Mother's age is 18-45 years
3. Single pregnancy
4. Live fetus
Criteria for not entering the study
1. Vaginal bleeding (threat of abortion).
3. Previous history of depression according to mother's statement
4. Having maternal or fetal indications for termination of pregnancy
5. Disagreement with the wife according to the statement of the mother
Intervention groups
After the implementation of phase one and two of the study, interventions to improve unplanned pregnancy experiences will be determined and implemented and evaluated during this phase.
Main outcome variables
Pregnancy experience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170506033834N12
Registration date:2024-02-12, 1402/11/23
Registration timing:prospective
Last update:2024-02-12, 1402/11/23
Update count:0
Registration date
2024-02-12, 1402/11/23
Registrant information
Name
Roghaiyeh Nourizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
nourizadehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and implementation of interventions to improve unplanned pregnancy experiences
Public title
Design and implementation of interventions to improve unplanned pregnancy experiences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with unplanned pregnancies
Mother's age is 18-45 years
singleton pregnancy
Live fetus
Exclusion criteria:
Vaginal bleeding (threat of miscarriage)
Previous history of depression according to mother's statement
Having maternal or fetal indications for termination of pregnancy
Disagreement with the wife according to mother's statement
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign the participants to the study groups, using the random block method, allocated according to the type of unplanned pregnancy (unwanted or untimely) It will be used with the size of blocks of 4 and 6 and with an allocation ratio of 1:1. For Allocation Concealment, the type of intervention is written on paper and inside matte envelopes on the back of the head. It will also be numbered. Then, the related envelope will be determined by a person not involved in open sampling and the type of intervention received.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is in line with the policy of having children and improving unplanned pregnancy experiences and reducing elective abortions
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht St., Tabriz University of Medical Sciences, Faculity of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.TBZMED.REC.1402.740
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pregnancy experiences
Timepoint
before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy with control of the baseline effect
Method of measurement
PES (Pregnancy Experience Scale) Questionnaire
Secondary outcomes
1
Description
Mother's anxiety
Timepoint
before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy by controlling the effect of the baseline score
Method of measurement
PRAQ (Pregnancy-Related Anxiety Questionnaire)
2
Description
depression
Timepoint
before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy by controlling the effect of the baseline score
Method of measurement
Edinburgh's Depression During Pregnancy Tool
3
Description
Perceived maternal violence
Timepoint
before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy with control of the baseline effect
before the start of the intervention and again after the intervention in the 35th to 37th week of pregnancy with control of the baseline effect
Method of measurement
Cranley's mother-fetus attachment questionnaire
5
Description
Preterm delivery
Timepoint
Frequency of preterm delivery with effect adjustment of baseline values
Method of measurement
Baby care card
Intervention groups
1
Description
Intervention group:The target population will be women aged 18 to 45 with an unplanned pregnancy who refer to Tabriz city health centers for prenatal care in 1403. In this step, sampling of mothers eligible to participate in the present study will be done using the available method, then Full explanations about the research, its goals and the method of its implementation will be given to the women. In case of desire to participate in the study, written informed consent will be obtained from the women and The participants will be provided with sufficient assurance regarding the confidentiality of the information obtained. , the violence and attachment of the mother to the fetus will be completed. In this study, pregnancy experience will be measured as the primary outcome and depression, anxiety, violence and attachment of the mother to the fetus and premature birth will be measured as secondary outcomes. In order to assign the participants to the study groups, using the random block method, allocated according to the type of unplanned pregnancy (unwanted or untimely) It will be used with the size of blocks of 4 and 6 and with an allocation ratio of 1:1. For Allocation Concealment, the type of intervention is written on paper and inside matte envelopes on the back of the head. It will also be numbered. Then the related envelope will be determined by a person not involved in open sampling and the type of intervention received. The type of intervention applied in the intervention group will be determined after reviewing the literature and qualitative study and holding an expert panel.
Category
Other
2
Description
Control group: No intervention will be applied in the control group and only routine prenatal care will be given.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
All health centers in Tabriz city
Full name of responsible person
Masoumeh Paiandeh
Street address
Resalat, Iqbal Azar Street, Shayan Mehr Complex
City
Tabriz
Province
East Azarbaijan
Postal code
5178757398
Phone
+98 83 4822 2257
Email
m_paiande@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Central Building, University of Tabriz, Golgasht St. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 7310 3335
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Paiandeh
Position
PhD student in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5313644351
Phone
+98 41 6770 3479
Email
m_paiande@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 0648
Email
nourizadehr@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
6615615733
Phone
+98 41 3477 0648
Email
nourizadehr@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available