Protocol summary

Summary
The study aims at determining the effect of delivery preparation consultation on the pregnancy outcome and the pregnant women's satisfaction in the Fatemieh hospital in Hamadan. Pregnancy outcome includes choosing the type of delivery, the experienced delivery, the infant's weight, the weight increase during pregnancy. The inclusion criteria are the pregnant women enjoying complete health, having no specific diseases, not having risky pregnancy, being at the gestational age ranging from 20 to 23 weeks, tending to participate in the educational classes, and not having taken part in similar classes. The population of the study is the pregnant women with mentioned criteria. The size of the sample is 170 women. Eighty five of them, as the experimental group, take part in consultation sessions, and 85 of them, as control group, just receive the routine pregnancy cares. The sampling technique will be randomized permutation block lie, AB BA, where A stands for experimental group and B for the control group. The design of this study is randomized trial-clinical control group. The experimental group will take part in 8 sessions of consultation classes from 20th to 36th week of their, but the control group will be exposed to routine pregnancy cares. Doing so, the pregnancy outcomes and the pregnant women's satisfaction will be compared in the groups. The instruments of collecting data are a researcher-made questionnaire concerning the satisfaction of pregnant women regarding delivery preparation consultation, demographic questionnaire, and the weighing balance of infant's and adult’s weight.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012513405N9
Registration date: 2015-05-19, 1394/02/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-19, 1394/02/29
Registrant information
Name
Seyyedeh Zahra Masoumi
Name of organization / entity
Hamedan University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
zahra.masoomi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-07-01, 1394/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of delivery preparation consult versus routine pregnancy cares on the pregnancy outcome and pregnant women’s satisfaction in the Fatemieh Hospital in Hamadan
Public title
The effect of delivery preparation consult on the pregnancy outcome and pregnant women’s satisfaction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Those women will be included who are certified by the physician to enjoy complete health; not being inflicted with a specific diseases such diabetes, cardio-vascular; their pregnancy will not be of high risk such as multi-twins, repeated abortion, placenta previa, preeclampsia; their gestational age will range from 20 to 23 weeks; having tendency to participate in educational classes; their previous delivery be NVD in the case of multipar women; and have not taken part in the similar educational classes. Exclusion criteria: Those women will be excluded who do not tend to participate in educational classes; make absence more than one session of consult; are not threatened by risk factors such as being conflicted with preeclampsia, amniotic fluid tear and preterm delivery.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 170
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
Ethics committee of Hamadan University of Medical Sciences
Street address
Research and Technology Deputy, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
6516645977
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
6371/9/35/16/پ

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
Z34.8
ICD-10 code description
Supervision of other normal pregnancy

Primary outcomes

1

Description
Birth weight
Timepoint
Immediately after delivery
Method of measurement
Weighing balance of infant's weight

2

Description
Choosing the type of delivery
Timepoint
20th and 36th week of pregnancy
Method of measurement
Questionnaire

3

Description
The type of delivery
Timepoint
Immediately after delivery
Method of measurement
Questionnaire

4

Description
Satisfaction
Timepoint
Before the intervention, after finishing the consult sessions
Method of measurement
Questionnaire

5

Description
The weight increase of mother during pregnancy
Timepoint
20th and 36th week of pregnancy
Method of measurement
Weighing balance

Secondary outcomes

1

Description
Apgar score
Timepoint
Immediately after delivery
Method of measurement
Check list

Intervention groups

1

Description
Experimental group: holding 8 session of consulting for pregnant women included nutrition, exercise, description about normal vaginal delivery etc, each taking 90 minutes
Category
Prevention

2

Description
Control group: routine pregnancy cares for pregnant women
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Simin Karimi (M.sc student of Consulting in Midwifery)
Street address
Fatemieh Hospital, Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Said Bashirian, Ph.D
Street address
Research and Technology Deputy, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoumi
Position
Associate professor
Other areas of specialty/work
Street address
The Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoumi
Position
Associate professor
Other areas of specialty/work
Street address
The Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
6516645977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Simin Karimi
Position
M.sc student of Consulting in Midwifery
Other areas of specialty/work
Street address
The Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
6515917734
Phone
+98 81 3824 5111
Fax
Email
Karimi.midwife.65@Gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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