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Internal Versus External Tocodynamometry and Labor Outcome

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02941393
Collaborator
Central Finland Hospital District (Other)
1,500
Enrollment
2
Locations
2
Arms
62
Duration (Months)
750
Patients Per Site
12.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intrauterine pressure catheter
  • Device: External tocodynamometry
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intrauterine pressure catheter

Intrauterine pressure catheter is used during labor to follow up the contractions

Device: Intrauterine pressure catheter
Other Names:
  • Internal tocodynamometry

    		•
    Active Comparator: External tocodynamometry

    External tocodynamometry is used during labor to follow up the contractions

    Device: External tocodynamometry

    Outcome Measures

    Primary Outcome Measures

    1. Number of cesarean sections [through study completion, an average of 6 years]

    2. Number of operative vaginal deliveries [through study completion, an average of 6 years]

    Secondary Outcome Measures

    1. Duration of labor [From time of first regular contraction to birth]

    2. Newborn admission to the pediatric care unit [3 days after birth]

    3. The use of Oxytocin during labor [From beginning of the use of oxytocin to the birth]

    4. Apgar scores [10 min after birth]

    5. Ph of umbilical artery [immediately after birth]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cetral Finland Central Hospital Jyväskylä Central Finland Finland 40640
    2 Tampere University Hospital Tampere Pirkanmaa Finland 33520

    Sponsors and Collaborators

    • Tampere University Hospital
    • Central Finland Hospital District

    Investigators

    • Principal Investigator: Tuija Hautakangas, MD, Central Finland Central Hospital, Tampere University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tuija Hautakangas, Medical doctor, Tampere University Hospital
    ClinicalTrials.gov Identifier:
    NCT02941393
    Other Study ID Numbers:
    • R12229
    First Posted:
    Oct 21, 2016
    Last Update Posted:
    Mar 20, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Tuija Hautakangas, Medical doctor, Tampere University Hospital
    internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia
    Additional relevant MeSH terms:
    Dystocia

    Study Results

    No Results Posted as of Mar 20, 2018