Internal Versus External Tocodynamometry and Labor Outcome

Tampere University Hospital1,500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,500

Conditions

Dystocia Contractions

Interventions

Intrauterine pressure catheterDEVICE

External tocodynamometryDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Cetral Finland Central Hospital

Jyväskylä, Central Finland, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Outcomes

Primary Outcomes

Number of cesarean sections

Time frame: through study completion, an average of 6 years

Number of operative vaginal deliveries

Time frame: through study completion, an average of 6 years

Secondary Outcomes

Duration of labor

Time frame: From time of first regular contraction to birth

Newborn admission to the pediatric care unit

Time frame: 3 days after birth

The use of Oxytocin during labor

Time frame: From beginning of the use of oxytocin to the birth

Apgar scores

Time frame: 10 min after birth

Ph of umbilical artery

Time frame: immediately after birth

Data from ClinicalTrials.gov

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