Back to resultsInternal Versus External Tocodynamometry and Labor Outcome
Primary Purpose
Dystocia, Contractions
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intrauterine pressure catheter
External tocodynamometry
Sponsored by
About this trial
This is an interventional treatment trial for Dystocia focused on measuring internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia
Eligibility Criteria
Inclusion Criteria:
- gestational age ≥ 37 weeks
- singleton pregnancy
- a fetus in cephalic position
- normal cardiotocograph in the time of randomization
- cervical ripening < 7 cm
- either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section
Exclusion Criteria:
- parturient with hepatitis or HIV or other significant viral infection
- Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
- Estimated fetal weight over 4,5 kg
- Suspected fetal abnormality
Sites / Locations
- Cetral Finland Central Hospital
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intrauterine pressure catheter
External tocodynamometry
Arm Description
Intrauterine pressure catheter is used during labor to follow up the contractions
External tocodynamometry is used during labor to follow up the contractions
Outcomes
Primary Outcome Measures
Number of cesarean sections
Number of operative vaginal deliveries
Secondary Outcome Measures
Duration of labor
Newborn admission to the pediatric care unit
The use of Oxytocin during labor
Apgar scores
Ph of umbilical artery
Full Information
NCT ID
NCT02941393
First Posted
September 7, 2016
Last Updated
March 19, 2018
Sponsor
Tampere University Hospital
Collaborators
Central Finland Hospital District
1. Study Identification
Unique Protocol Identification Number
NCT02941393
Brief Title
Internal Versus External Tocodynamometry and Labor Outcome
Official Title
Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Central Finland Hospital District
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystocia, Contractions
Keywords
internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrauterine pressure catheter
Arm Type
Active Comparator
Arm Description
Intrauterine pressure catheter is used during labor to follow up the contractions
Arm Title
External tocodynamometry
Arm Type
Active Comparator
Arm Description
External tocodynamometry is used during labor to follow up the contractions
Intervention Type
Device
Intervention Name(s)
Intrauterine pressure catheter
Other Intervention Name(s)
Internal tocodynamometry
Intervention Type
Device
Intervention Name(s)
External tocodynamometry
Primary Outcome Measure Information:
Title
Number of cesarean sections
Time Frame
through study completion, an average of 6 years
Title
Number of operative vaginal deliveries
Time Frame
through study completion, an average of 6 years
Secondary Outcome Measure Information:
Title
Duration of labor
Time Frame
From time of first regular contraction to birth
Title
Newborn admission to the pediatric care unit
Time Frame
3 days after birth
Title
The use of Oxytocin during labor
Time Frame
From beginning of the use of oxytocin to the birth
Title
Apgar scores
Time Frame
10 min after birth
Title
Ph of umbilical artery
Time Frame
immediately after birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
gestational age ≥ 37 weeks
singleton pregnancy
a fetus in cephalic position
normal cardiotocograph in the time of randomization
cervical ripening < 7 cm
either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section
Exclusion Criteria:
parturient with hepatitis or HIV or other significant viral infection
Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
Estimated fetal weight over 4,5 kg
Suspected fetal abnormality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuija Hautakangas, MD
Organizational Affiliation
Central Finland Central Hospital, Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cetral Finland Central Hospital
City
Jyväskylä
State/Province
Central Finland
ZIP/Postal Code
40640
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internal Versus External Tocodynamometry and Labor Outcome
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