Internal Versus External Tocodynamometry and Labor Outcome

Dystocia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941393
• Other study ID #: R12229
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: March 19, 2018
• Start date: November 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contractions
• Dystocia

Intervention

Device:
• Intrauterine pressure catheter

• External tocodynamometry

Locations

Country	Name	City	State
Finland	Cetral Finland Central Hospital	Jyväskylä	Central Finland
Finland	Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Central Finland Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cesarean sections		through study completion, an average of 6 years
Primary	Number of operative vaginal deliveries		through study completion, an average of 6 years
Secondary	Duration of labor		From time of first regular contraction to birth
Secondary	Newborn admission to the pediatric care unit		3 days after birth
Secondary	The use of Oxytocin during labor		From beginning of the use of oxytocin to the birth
Secondary	Apgar scores		10 min after birth
Secondary	Ph of umbilical artery		immediately after birth