Internal Versus External Tocodynamometry and Labor Outcome

Study Overview
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Brief Summary
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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.

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

Conditions
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Dystocia, Contractions

Intervention / Treatment
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* Device: Intrauterine pressure catheter
* Device: External tocodynamometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrauterine pressure catheter<br>Intrauterine pressure catheter is used during labor to follow up the contractions | Device: Intrauterine pressure catheter<br> <br> * Other names: Internal tocodynamometry;|
| Active Comparator: External tocodynamometry<br>External tocodynamometry is used during labor to follow up the contractions | Device: External tocodynamometry<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of labor |  | From time of first regular contraction to birth | 
| 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 | 
| Apgar scores |  | 10 min after birth | 
| Ph of umbilical artery |  | immediately after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia