Internal Versus External Tocodynamometry and Labor Outcome

Tampere University Hospital

Status: Completed

Conditions: Contractions; Dystocia

Treatments: Device: External tocodynamometry; Device: Intrauterine pressure catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02941393

R12229

Details and patient eligibility

About

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.

Enrollment: 1,500 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Intrauterine pressure catheter

Active Comparator group

Description:

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

Treatment:

Device: Intrauterine pressure catheter

External tocodynamometry

Active Comparator group

Description:

External tocodynamometry is used during labor to follow up the contractions

Treatment:

Device: External tocodynamometry