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OpenTrials
Completed

NCT Number: NCT02941393

Internal Versus External Tocodynamometry and Labor Outcome

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.

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Key information

Conditions

Dystocia Contractions Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cetral Finland Central Hospital, Jyväskylä, Central Finland, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrauterine Pressure Catheter

Device

Other names: Internal tocodynamometry

External tocodynamometry

Device

Primary outcomes

  1. Number of cesarean sections

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

  2. Number of operative vaginal deliveries

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

Secondary outcomes

  1. Duration of labor

    Time frame: From time of first regular contraction to birth

  2. Newborn admission to the pediatric care unit

    Time frame: 3 days after birth

  3. The use of Oxytocin during labor

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

  4. Apgar scores

    Time frame: 10 min after birth

  5. Ph of umbilical artery

    Time frame: immediately after birth

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Central Finland Hospital District

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2016
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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