Internal Versus External Tocodynamometry and Labor Outcome

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02941393

Enrollment

1500

Registered

2016-10-21

Start date

2012-11-30

Completion date

2017-12-31

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contractions, Dystocia

Keywords

internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia

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.

Interventions

DEVICEIntrauterine pressure catheter

DEVICEExternal tocodynamometry

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
Ph of umbilical artery	immediately after birth
Apgar scores	10 min after birth
Newborn admission to the pediatric care unit	3 days after birth

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026