Internal Versus External Tocodynamometry and Labor Outcome
Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn
1 other identifier
interventional
1,500
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
2 active sites
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
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMarch 20, 2018
March 1, 2018
5.2 years
September 7, 2016
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of cesarean sections
through study completion, an average of 6 years
Number of operative vaginal deliveries
through study completion, an average of 6 years
Secondary Outcomes (5)
Duration of labor
From time of first regular contraction to birth
Newborn admission to the pediatric care unit
3 days after birth
The use of Oxytocin during labor
From beginning of the use of oxytocin to the birth
Apgar scores
10 min after birth
Ph of umbilical artery
immediately after birth
Study Arms (2)
Intrauterine pressure catheter
ACTIVE COMPARATORIntrauterine pressure catheter is used during labor to follow up the contractions
External tocodynamometry
ACTIVE COMPARATORExternal tocodynamometry is used during labor to follow up the contractions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Central Finland Hospital Districtcollaborator
Study Sites (2)
Cetral Finland Central Hospital
Jyväskylä, Central Finland, 40640, Finland
Tampere University Hospital
Tampere, Pirkanmaa, 33520, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuija Hautakangas, MD
Central Finland Central Hospital, Tampere University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
September 7, 2016
First Posted
October 21, 2016
Study Start
November 1, 2012
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
March 20, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share