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The effect of continuity of midwifery care during labor on child birth Outcomes in patients referring to 29 Bahman hospital, Tabriz, 1388.

Protocol summary

Summary
This study with quasi – experimental design, will be conducted to assess the effect of continuity of midwifery care, in childbirth course, on mother and child health, in non- complicated (medical and obstetrical complications in pregnancy) parturient, which referring to study center for normal vaginal delivery. Parturient in two groups, will receive different kind of midwifery care. In conventional care group: the clients will be cared (from admission time in delivery part till one hour after delivery) by a group of duty midwives, and visit regularly at 1:30–2 hour intervals, in admission and labor and delivery sections. But in continuity of care group, one midwife will care, from admission time in delivery part till one hour after delivery; she lefts clients bedside only for several minutes. Then consequences of each kind of care, as childbirth outcome, will be recorded in self administer check list and analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104103027N4
Registration date: 2011-07-11, 1390/04/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-11, 1390/04/20
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of the Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuity of midwifery care during labor on child birth Outcomes in patients referring to 29 Bahman hospital, Tabriz, 1388.
Public title
The effect of continuity of midwifery care during labor on child birth Outcomes in patients referring to 29 Bahman hospital, Tabriz, 1388.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Parity lowers than 5; normal pregnancy (without multiple pregnancies, fetus and placental problems…); lack of internal – surgical affliction in mother; no distress in fetus; normal pelvic diameters (by vaginal examination); lack of psychological disorders and communication barriers in mother; lack of drug abuse in mother; being in active phase of labor; lack of cesarean section in history; maternal age 18 – 35; viable and term fetus; estimated body weight in fetus lower than 4000 germs; without premature rupture of membranes and abnormal vaginal bleeding and willing to participate in the study Exclusion criteria: Client's changing mind from continuity of care; fetal distress; emergency problems for mother such as placental abruption.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Primary sampling from the society by non- probability sampling (convenience) and allocation of the samples in two groups by simple random sampling

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan
City
Tabriz
Postal code
Approval date
2008-12-16, 1387/09/26
Ethics committee reference number
5/4/2421

Health conditions studied

1

Description of health condition studied
The effect of special manner of the midwifery cares offering in delivery stages on normal delivery outcomes
ICD-10 code
O36.9
ICD-10 code description
Maternal care for fetal problem, unspecified

Primary outcomes

1

Description
Kind of delivery
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

2

Description
First and fifth minute neonate’s Apgar score
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

3

Description
Length of first and second stage of labor
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

4

Description
Induced ( episiotomy) and spontaneous tears in perinea and vagina
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

Secondary outcomes

1

Description
Uterus atonia in fourth stage
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

2

Description
Method of membranes rupture
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

3

Description
Amount of used Oxytocine in labor
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

4

Description
Neonate’s gender and body weight
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

5

Description
Client’s fertility characteristics
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

6

Description
Fetal heart rates pattern in labor
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

7

Description
Uterus contractions pattern in labor
Timepoint
In first, second, third and fourth stage of delivery and childbirth
Method of measurement
Validated and reliable self administer check list for record the birth outcomes

Intervention groups

1

Description
In conventional care group: the clients (from admission time in delivery part till one hour after delivery), will care by a group of duty midwives, visit regularly at 1:30–2 hour intervals, in admission, labor and delivery sections. In this group, continuity and continuous presence of caregiver will not present.
Category
Other

2

Description
In continuity of care group: the clients will care by one midwife from admission time in delivery part till one hour after delivery. This midwife will not leave client's bedside for more than a few minutes. The caregiver(midwife) will offer midwifery care in labor; will perform delivery and all postpartum cares. The caregiver will remain in parturient's bedside, when she is examining by on call obstetrician and will perform all of the physician’s orders.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz, 29 Bahman hospital
Full name of responsible person
Fahimeh Sehhatie Shafaie
Street address
Nursing & midwifery faculty of Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mir Ali Eateraf Oskui
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
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
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Uroumieh University of Medical Sciences
Full name of responsible person
Maryam Najarzadeh
Position
Master in midwifery
Other areas of specialty/work
Street address
Shahid Rasi hospital, Shahid Dast Geyb Street, Pasdaran Avenue, Shahindezh, West Azerbaijan
City
Shahindezh
Postal code
Phone
+98 41 1422 2135
Fax
Email
maryam.najjarzadeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Mmedical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
Master in midwifery, Instructor of Tabriz nursing & midwifery faculty
Other areas of specialty/work
Street address
Tabriz nursing & midwifery faculty, South Shariaty Street, Shariaty Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
Phone
Fax
Email
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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