- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01649063
Comparing the Shape and Frequency of Uterine Contractions
July 24, 2012 updated by: Samira Ebrahimzadeh Zagami, Mashhad University of Medical Sciences
Principle Investigator
Dystocia is the most common indication for primary cesarean section.
The most common cause of dystocia is uterine dysfunction.
In all cephalopelvic disproportion studies, more attention is usually paid on fetus and pelvic rather than on the role of uterine contraction in delivery.
So we decided to determine the relationship between dystocia and uterine contraction patterns.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
95
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
primiparous women
Description
Inclusion Criteria:
- age 18-35 years
- singleton pregnancy with cephalic term presentation
- tendency to do vaginal delivery
- having no medical or mental diseases
- having no pregnancy complications
- Intact membranes
- BMI<26
Exclusion Criteria:
- using oxytocin before and during the monitoring of contractions
- performing cesarean section for any reason except arrested delivery or pelvic constriction
- the birth weight< 2500 or >4000
- using the analgesia such as epidural anesthesia morphine and pethidine during the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
the shape and frequency of uterine contractions in delivery
Uterine contractions were recorded by using fetal monitoring system (Model FC1400) at the beginning of the active phase (cervical dilatation 3-4 cm) for 30 min in two groups.
|
|
the shape and frequency of uterine contractions in cesarean
Uterine contractions were recorded by using fetal monitoring system (Model FC1400) at the beginning of the active phase (cervical dilatation 3-4 cm) for 30 min in two groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the shape and frequency of uterine contractions
Time Frame: up to 15 months
|
Uterus contractions were recorded using electronic fetal monitoring at the beginning of the active phase of labor (dilatation 3-5 cm) for 30 min.
|
up to 15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 21, 2012
First Submitted That Met QC Criteria
July 24, 2012
First Posted (Estimate)
July 25, 2012
Study Record Updates
Last Update Posted (Estimate)
July 25, 2012
Last Update Submitted That Met QC Criteria
July 24, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- vaginal delivery and cesarean
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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