Internal Versus External Tocodynamometry and Labor Outcome

March 19, 2018 updated by: Tuija Hautakangas, Tampere University Hospital

Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Central Finland
      • Jyväskylä, Central Finland, Finland, 40640
        • Cetral Finland Central Hospital
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of cesarean sections
Time Frame: through study completion, an average of 6 years
through study completion, an average of 6 years
Number of operative vaginal deliveries
Time Frame: through study completion, an average of 6 years
through study completion, an average of 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of labor
Time Frame: From time of first regular contraction to birth
From time of first regular contraction to birth
Newborn admission to the pediatric care unit
Time Frame: 3 days after birth
3 days after birth
The use of Oxytocin during labor
Time Frame: From beginning of the use of oxytocin to the birth
From beginning of the use of oxytocin to the birth
Apgar scores
Time Frame: 10 min after birth
10 min after birth
Ph of umbilical artery
Time Frame: immediately after birth
immediately after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Central Finland Hospital District

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R12229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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