NCT01649063

Brief 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. So we decided to determine the relationship between dystocia and uterine contraction patterns.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

July 21, 2012

Last Update Submit

July 24, 2012

Conditions

Keywords

Uterine contraction;Shape; Frequency;First stage labor;FallRise ratio.

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 15 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primiparous women

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Nursing & Midwifery

Study Record Dates

First Submitted

July 21, 2012

First Posted

July 25, 2012

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

July 25, 2012

Record last verified: 2012-07