Uterine ContractionsNCT01649063
Comparing the Shape and Frequency of Uterine Contractions
An observational study of Uterine Contractions and Delivery, run by Mashhad University of Medical Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Contractions, Delivery
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: primiparous women
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Uterine Contractions, Delivery
- Keywords
- Uterine contraction;, Shape; Frequency;, First stage labor;, Fall, Rise ratio.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
the shape and frequency of uterine contractions
Uterus contractions were recorded using electronic fetal monitoring at the beginning of the active phase of labor (dilatation 3-5 cm) for 30 min.
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ContractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Ebrahimzadeh Zagami, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649063
- Sponsor's protocol ID
- vaginal delivery and cesarean
- Status last verified
- Jul 2012
- First submitted
- 21 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principle Investigator
- ClinicalTrials.gov ID
- NCT01649063
- Acronym / sponsor ID
- vaginal delivery and cesarean
- Conditions
- Uterine Contractions, Delivery
- Keywords
- Uterine contraction;, Shape; Frequency;, First stage labor;, Fall, Rise ratio.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- primiparous women
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Contractions and Delivery, run by Mashhad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the shape and frequency of uterine contractions (time frame: up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2012.