The purpose of this study is the assessment of the effect of permanent fetus heart monitoring among low risk pregnancies during labor. In this study, 900 pregnant women who have one cephalic fetus, being in labor phases and not having the exclusion criteria such as IUGR; diabetes; preeclampsia will randomly assigned to 2 intervention and control groups using sealed envelopes. In intervention group, the FHR will be assessed by sonicate every 15 minutes and in control group the FHR will be assessed through monitoring machine permanently. After labor, neonatal outcomes such as Apgar score and root of delivery will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102330437N2
Registration date:2017-02-16, 1395/11/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-16, 1395/11/28
Registrant information
Name
Lida Jedi
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 6199
Email address
jeddil931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University Of Medical Science
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of Neonatal Outcome Of Fetus Heart Monitoring With Intermittent Auscultation And Permanent Monitoring In Low Risk Women During Labor
Public title
Evaluation Of Neonatal Outcome Of Fetus Heart Monitoring
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria : Pregnant women with one cephalic fetus admitted for labor.
Exclusion criteria : More than one fetus; Previous fetal death; Preeclampsia; Diabetes; Intra uterine growth retardation; Sepsis; Chorioamnionitis; Vaginal bleeding; Oxytocin usage.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
900
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using sealed envelopes
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University Of Medical Science
Street address
Pardise University, Azadi Square
City
Mashhad
Postal code
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.MUMS.fm.REC.1395.163
Health conditions studied
1
Description of health condition studied
Neonatal Out Come In Low Risk Pregnancy
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Neonatal Apgar Score
Timepoint
One minute and 5 minutes after birth
Method of measurement
Apgar Score Scale
Secondary outcomes
1
Description
Delivery by Cesarean Section
Timepoint
After Neonate Birth
Method of measurement
Registeration documents
2
Description
Asphyxia
Timepoint
After Neonate Birth
Method of measurement
Nochal cord PH, clinical examination
3
Description
NICU Admission
Timepoint
After Neonatal Birth
Method of measurement
Registeration documents
Intervention groups
1
Description
Intervention Group 1:Permanent FHR monitoring during labor with Bionet Fetal Monitor Machine made in Korea
Category
Diagnosis
2
Description
Control Group:FHR control with Bionet sonicate made in Korea every 15 minutes during labor.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Lida Jedi
Street address
Taghi Abad Square
City
Mashhad
2
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Lida Jedi
Street address
Emam Reza Square
City
Mashhad
3
Recruitment center
Name of recruitment center
Omol-Banin Hospital
Full name of responsible person
Lida Jedi
Street address
16th Behjat Khorasani Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Pardis University, Azadi Square
City
Mashhad
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,Mashhad 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
Mashhad University Of Medical Science
Full name of responsible person
Lida Jedi
Position
Obstetrics And Gynecology Assistant
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3768 6199
Fax
Email
jeddil931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Science
Full name of responsible person
Leila Pourali
Position
Gynocologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3801 2477
Fax
Email
pouralil@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Lida Jedi
Position
Obstetrics and Gynecology Assistant
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3768 6199
Fax
Email
jeddil931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)