This study is a randomized clinical trial. The sample population is pregnant women in Kashan city. One hundred women will be under continuous care model (case group) and one hundred women will be received routine care (control group). The subjects will be recruited by random multistage method. The Kashan city will be divided according to the comprehensive health centers. Seven centers will be selected randomly. The sample size of every area will be calculated according to the population coverage of the centers. The eligible samples will be appointed randomly. The control and case group will be matched according to the number of pregnancies, birth, age, education, occupation, economic status and residency. The data will be gathered using questionnaire, interview form and check list. Maternal and neonatal outcomes and maternal satisfaction will be compared in two groups using SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408318801N9
Registration date:2016-08-15, 1395/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-15, 1395/05/25
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University Of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of continuous midwifery care model during pregnancy, labor and postpartum on maternal and neonatal
Public title
Development and evaluating a model of continuous midwifery care during pregnancy, labor and postpartum, an action research study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The Low risk pregnant women that:
- Their gestational age is under fourteen weeks
- They have not any diseases
- They have not previous high risk pregnancy
- They have not history for infertility
- They have not previous cesarean section
- They have not previous abdominal surgery
Exclusion criteria:
- Their pregnancy be high risk
- They have no desire to continue staying in the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not 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 Kashan University of Medical Sciences
Street address
Nurse street, Ravand High Way
City
Kashan
Postal code
8715587111
Approval date
2014-10-11, 1393/07/19
Ethics committee reference number
پ/29/5/1/3312
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
000-099
ICD-10 code description
Supervision of normal pregnancy, unspecified
Primary outcomes
1
Description
maternal satisfaction
Timepoint
1 month after intervention
Method of measurement
Questionnaire
2
Description
maternal outcomes
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
3
Description
neonatal outcomes
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
4
Description
number of visits in pregnancy
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
5
Description
number of sonography
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
6
Description
fetal death before or after 24 weeks
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
7
Description
hospitalization
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
8
Description
bleeding before delivery
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
9
Description
husband presence in visits
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
10
Description
induction
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
11
Description
physiologic delivery
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
12
Description
analgesic and anesthesia
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
13
Description
duration of labor
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
14
Description
duration of hospitalization
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
15
Description
delivery type
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
16
Description
episiotomy
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
17
Description
perineal laceration
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
18
Description
gestational age at the termination
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
19
Description
neonatal weight
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
20
Description
preterm neonate
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
21
Description
5th minute Apgar score
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder
22
Description
NICU hospitalization
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
23
Description
depression after delivery
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and interview
24
Description
breast feeding onset
Timepoint
at the end of intervention
Method of measurement
interview
25
Description
continuous pain after delivery
Timepoint
at the end of intervention
Method of measurement
interview
26
Description
expenditure
Timepoint
at the end of intervention
Method of measurement
observe the hospital folder and calculation
Secondary outcomes
empty
Intervention groups
1
Description
The intervention in case group includes: Hiring a responsible midwife for every pregnant woman. This midwife is a member of management team and provides direct care during prenatal, delivery and postpartum stages. If pregnant women need special care, the midwife will refer her to the specialist and will take feedback. Responsible midwife will continuously be available for pregnant women in different settings of home, health centers and hospital.
Category
Other
2
Description
The control group will receive routine care. In routine method, pregnant women refer to health center. There is not responsible midwife or continuous relationship with care provider. Most of women are under supervision of specialist no matter, they are high or low risk. Care providers change repeatedly during prenatal, delivery and postpartum stages. Care provider may be unknown for women.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabih Khani Hospital
Full name of responsible person
Fatemeh Rezvanitabar
Street address
Shahid Beheshti Street, Kashan
City
Kashan
2
Recruitment center
Name of recruitment center
Golabchi health center
Full name of responsible person
Fatemeh Nazarneia
Street address
Emam street, Kashan
City
Kashan
3
Recruitment center
Name of recruitment center
Moslem health center
Full name of responsible person
Maliheh Sarvizadeh
Street address
Rajaee Street, Kashan
City
Kashan
4
Recruitment center
Name of recruitment center
Emam Ali health center
Full name of responsible person
Fatemeh Rafee
Street address
Nagiabad street, Kashan
City
Kashan
5
Recruitment center
Name of recruitment center
Sadeghpour health center
Full name of responsible person
Maryam Javani
Street address
Emam Javad street, Kashan
City
Kashan
6
Recruitment center
Name of recruitment center
Karegar health center
Full name of responsible person
Zohreh Rabbani
Street address
Karegar street, Kashan
City
Kashan
7
Recruitment center
Name of recruitment center
Matini health center
Full name of responsible person
Zahra Zare
Street address
Amir Kabir Street, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
Kashan University of Medical Sciences
Full name of responsible person
Azam Bagheri
Position
Trainee
Other areas of specialty/work
Street address
Nurse Street, Ravand High Way
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
asambagheri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
Associate Professor
Other areas of specialty/work
Street address
Crossing Vali-Asr Neiayesh
City
Tehran
Postal code
Phone
+98 21 8820 2519
Fax
Email
msimbar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Azam Bagheri
Position
Trainee
Other areas of specialty/work
Street address
Midwifery Group, School of nursing and midwifery, Nurse Street, Ravand High Way, Kashan
City
Kashan
Postal code
8715587111
Phone
+98 31 5554 0021
Fax
+98 31 5554 3366
Email
asambagheri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)