Protocol summary

Summary
Objective: We assessed the results of using partogram in labor management. Methods: a prospective controlled trial was carried out on 200 primiparous laboring women who were in active labor in Alborz hospital (Karaj, Iran) between Jul 2006-Feb 2007. They were randomly assigned in two groups. Decision making in labor management in partogram group was taken based on partogram guidelines whereas routine intrapartum care via written notes in control group. We assesed the following variables: comparison the prolonged labor in two groups, comparison the mean length of the first stage of labor in two groups, comparison the mean length of the second stage of labor in two groups, comparison the mean total length of labor in two groups, comparison cesarean and normal vaginal delivery rate in two groups, comparison the neonatal outcomes on the basis of 1th and 5th minute Apgar score in two groups.

General information

Acronym
Labor management based on partogram
IRCT registration information
IRCT registration number: IRCT2012122811911N1
Registration date: 2013-09-24, 1392/07/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-24, 1392/07/02
Registrant information
Name
Zarrin Ajoodani
Name of organization / entity
Islamic Azad university
Country
Iran (Islamic Republic of)
Phone
+98 26134418143
Email address
zarin.ajoodani@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research office, Islamic Azad University, Karaj Branch
Expected recruitment start date
2005-07-23, 1384/05/01
Expected recruitment end date
2006-07-23, 1385/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Results of using partogram in labor management
Public title
Labour control based on labor chart( partogram)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: all of the primiparous laboring women who admitted in Alborz hospital (Karaj,Iran) for delivery. We excluded parturient who had gestational age ≤ 37 weeks; history of any prior operation on uterus; malpresentation; multiparty; multiple pregnancies; cervical dilation ≥ 4 cm at the time of admitting; symptoms of fetal distress or obstetric/medical complication.
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Karaj Branch
Street address
ALBORZ
City
karaj
Postal code
Approval date
2005-04-13, 1384/01/24
Ethics committee reference number
47281/4

Health conditions studied

1

Description of health condition studied
Partogram
ICD-10 code
O80-84
ICD-10 code description
Delivery

Primary outcomes

1

Description
The length of labor stages
Timepoint
1 hour interval in labor
Method of measurement
partogram of WHO

Secondary outcomes

1

Description
Delivery method
Timepoint
At the end of delivery
Method of measurement
Record of normal vaginal delivery or cesarean

2

Description
Neonatal outcomes
Timepoint
1th and 5th minute after delivery
Method of measurement
APGAR score system

Intervention groups

1

Description
Intervention group: Progress of labor was recorded on standard partogram chart based on cervical dilatation and descend in partogram group and decision making in labor management was taken based on WHO - partogram guidelines. Once cervicograph cut the alarm line, intervention included amniotomy and low dose oxytocin augmentation carried out;also if cervix was unripe, anticholinergic drugs such as Atropin or Hyocsin intramuscularly administered, or Promethazin for vomitting was used. when the cervicograph lagged the action line cesarean section was performed.
Category
Other

2

Description
Control group :, partogram was recorded for control group as well as partogram group, but decision making was only based on routine and exprimental intrapartum care through responsible physicion, without partogram results
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alborz hospital
Full name of responsible person
zarrin ajoodani
Street address
Baghestan
City
karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research office of Islamic Azad University of Karaj Branch
Full name of responsible person
Dr. Hajikhani
Street address
Moazen street
City
Karj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research office of Islamic Azad University of Karaj Branch
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
Islamic Azad University of Karaj Branch
Full name of responsible person
Zarrin Ajoodani
Position
Obstetrician& gynacologist
Other areas of specialty/work
Street address
Moazen blv.
City
Karaj
Postal code
Phone
+98 264182577
Fax
Email
zarrinajoodani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Karaj Branch
Full name of responsible person
Zarrin Ajoodani
Position
Obstetrician& gynacologist
Other areas of specialty/work
Street address
Moazen street
City
Karaj
Postal code
Phone
+98 26 3418 2577
Fax
Email
zarrinajoodani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Karaj Branch
Full name of responsible person
Zarrin Ajoodani
Position
Obstetrician& gynacologist
Other areas of specialty/work
Street address
Moazen street
City
Karaj
Postal code
Phone
Fax
Email
zarrinajoodani@yahoo.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
Loading...