Internal Versus External Tocodynamometry and Labor Outcome

Not Applicable

Completed

• Conditions: Dystocia; Contractions
• Interventions: Device: External tocodynamometry; Device: Intrauterine pressure catheter

• Registration Number: NCT02941393
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External tocodynamometry	External tocodynamometry	External tocodynamometry is used during labor to follow up the contractions
Intrauterine pressure catheter	Intrauterine pressure catheter	Intrauterine pressure catheter is used during labor to follow up the contractions

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Duration of labor	From time of first regular contraction to birth
Apgar scores	10 min after birth
Ph of umbilical artery	immediately after birth

Trial Locations

Locations (2)

Cetral Finland Central Hospital; 🇫🇮 Jyväskylä, Central Finland, Finland

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland