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Clinical Trials/NCT03126136
NCT03126136
Completed
N/A

Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities

Hopital Foch4 sites in 1 country1 target enrollmentDecember 12, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Labor
Sponsor
Hopital Foch
Enrollment
1
Locations
4
Primary Endpoint
Fetal heart rate
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in women with a low admission pulse pressure than those with a normal admission pulse. The aim of the present study is to look for a statistical link between the occurrence of a fetal heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions: dorsal decubitus position and in the left lateral decubitus.

Registry
clinicaltrials.gov
Start Date
December 12, 2018
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • pregnant women
  • gestational age ≥ 36 weeks
  • single eutrophic fetus
  • wishing for epidural analgesia
  • cervical dilatation less than or equal to 5 cm
  • spontaneous labor
  • scheduled for a vaginal delivery.
  • Non-inclusion Criteria:
  • prematurity (\< 36 weeks of amenorrhea) or post-term birth
  • intention of induction of labour using oxytocin before epidural analgesia or prostaglandin

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Fetal heart rate

Time Frame: 4 days

Fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention. Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention.

Secondary Outcomes

  • Newborn heart rate, blood pressure, pulse pressure, and cardiac output(4 days)
  • Mode of delivery(4 days)
  • Number of patients with hemodynamic abnormalities(4 days)
  • Fetal heart rate(4 days)

Study Sites (4)

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