1. Determine and compare the effect of early and late amniotomy on the outcomes of labor
Design
In this clinical trial study with control group, 70 non-complicated pregnant women with term pregnancy and beginning of spontaneous labor are randomly divided into two groups: Intervention group 1 or early amniotomy (<4 cm) and Intervention group 2 or late amniotomy(≤4 cm). The duration of labor and Apgar score were compared in two groups.
Settings and conduct
Pregnant women who referred to the Imam Ali Hospital(Amol), and had a tendency to participate in research and normal delivery conditions, were randomly divided into two groups. Written consent was received from them after the explanation of the terms of the work.
Participants/Inclusion and exclusion criteria
Major entry conditions: Primigravida pregnant women; and Major exit conditions: Multiple pregnancy, Preterm labor, Previous cesarean section.
Intervention groups
Intervention group 1 or early amniotomy group
Intervention group 2 or late amniotomy group
Main outcome variables
The length of the first stage of labor, the length of the second stage of labor, and the length of the third stage of labor, first minute Apgar, fifth minute Apgar.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120630010147N3
Registration date:2018-11-11, 1397/08/20
Registration timing:retrospective
Last update:2018-11-11, 1397/08/20
Update count:0
Registration date
2018-11-11, 1397/08/20
Registrant information
Name
omolbanin zare
Name of organization / entity
Islamic Azad University of Babol Branch
Country
Iran (Islamic Republic of)
Phone
+98 12 1323 9525
Email address
zare@baboliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of babol branch
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-21, 1395/06/31
Actual recruitment start date
2016-06-04, 1395/03/15
Actual recruitment end date
2016-11-05, 1395/08/15
Trial completion date
2017-04-09, 1396/01/20
Scientific title
Comparison of the Effectiveness of Early and late Amniotomy in Delivery Outcomes in primigravida women
Public title
Early and late Amniotomy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
primigravida pregnant women who have normal delivery conditions
They are 20 to 35 years old
Single and live birth fetus (37-40 weeks) is with a cephalic presentation
Water bag is healthy
In the first stage, pregnant women were randomly assigned to one of two groups using two envelopes containing early or late amniotomy procedure, the first person in the late amniotomy group and the next in the group of early amniotomy, and thus continued.
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 Islamic Azad University, Babylon Branch
Street address
Islamic Azad University of Babol Branch, 3 km Babol Road to Qa'em city
City
Babol
Province
Mazandaran
Postal code
47471-37381
Approval date
2018-09-02, 1397/06/11
Ethics committee reference number
IR.IAU.BABOL.REC.1397.002
Health conditions studied
1
Description of health condition studied
Amniotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The length of the first stage of labor
Timepoint
The end of the first stage
Method of measurement
A clock
2
Description
The length of the second stage of labor
Timepoint
The end of the second stage
Method of measurement
A clock
3
Description
The length of the third stage of labor
Timepoint
The end of the third stage
Method of measurement
A clock
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group or early amniotomy,which was done the rupture of the membranes in the dilatation less than 4 cm, and Amniotomy was performed with a device called the amniotomy hook of Qavami's manufactured products in Irn.
Category
N/A
2
Description
Control group: The control group or the late amniotomy, which was done the rupture of the membranes in the dilatation equal to or greater than 4 cm, based on routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Mahbobeh Baghipour
Street address
Imam Ali Hospital, Noor Road
City
Amol
Province
Mazandaran
Postal code
4149746171
Phone
+98 11 4426 4662
Email
baghipour425@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Babol Branch
Full name of responsible person
Reza changizi
Street address
Islamic Azad University of Babol Branch, 3 km from Babol Road to Qa'em city
City
Babol
Province
Mazandaran
Postal code
47471-37381
Phone
+98 11 3241 5078
Email
changizi@baboliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Babol Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University of Babol Branch
Full name of responsible person
Ommolbanin Zare
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University of Babol Branch, 3 km from Babol Road to Qa'em city
City
Babol
Province
Mazandaran
Postal code
47471-37381
Phone
+98 11 4329 4955
Fax
Email
mahyazare@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Babol Branch
Full name of responsible person
Ommolbanin Zare
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University of Babol Branch, 3 km from Babol Road to Qa'em city
City
Babol
Province
Mazandaran
Postal code
47471-37381
Phone
+98 11 4329 4955
Fax
Email
mahyazare@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Babol Branch
Full name of responsible person
Ommolbanin Zare
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University of Babol Branch, 3 km from Babol Road to Qa'em city
City
Babol
Province
Mazandaran
Postal code
47471-37381
Phone
+98 11 4329 4955
Fax
Email
mahyazare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the main outcome is shared.
When the data will become available and for how long
The start of the access period will be 6 months after the publication of the results.
To whom data/document is available
Data will be available to researchers working in academic institutions.
Under which criteria data/document could be used
To advance science
From where data/document is obtainable
mahyazare@yahoo.com
What processes are involved for a request to access data/document