NCT03126136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

3.1 years

First QC Date

March 21, 2017

Last Update Submit

August 2, 2022

Conditions

LaborEpidural Analgesia

Keywords

Fetal heart rate abnormalitiesPregnancyEpidural analgesiaPulse pressure

Outcome Measures

Primary Outcomes (1)

  • Fetal heart rate

    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.

    4 days

Secondary Outcomes (4)

  • Fetal heart rate

    4 days

  • Mode of delivery

    4 days

  • Newborn heart rate, blood pressure, pulse pressure, and cardiac output

    4 days

  • Number of patients with hemodynamic abnormalities

    4 days

Study Arms (1)

Pregnant women

EXPERIMENTAL
Device: Nicom (TM)

Interventions

Nicom (TM)DEVICE

Heart rate, arterial pressure and cardiac output measurements (monitor NICOM) performed in the dorsal decubitus position and in the left lateral decubitus

Pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • prematurity (\< 36 weeks of amenorrhea) or post-term birth
  • intention of induction of labour using oxytocin before epidural analgesia or prostaglandin
  • contraindication to epidural analgesia
  • history of hypertension or gravidic hypertension or heart disorder
  • gestational diabetes
  • foetal malformation or oligohydramnios or fetal growth abnormality
  • fœtal macrosomia diagnosed by ultrasonic scanning
  • hematocrit less than 20%

You may not qualify if:

  • induction of labour using oxytocin before epidural analgesia
  • newborn weight \> 4kg at birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AP-HP Hopital Antoine Beclere

Clamart, 92140, France

Location

Institut Hospitalier Franco-Britannique

Levallois-Perret, 92300, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (1)

  • Miller NR, Cypher RL, Nielsen PE, Foglia LM. Maternal pulse pressure at admission is a risk factor for fetal heart rate changes after initial dosing of a labor epidural: a retrospective cohort study. Am J Obstet Gynecol. 2013 Oct;209(4):382.e1-8. doi: 10.1016/j.ajog.2013.05.049. Epub 2013 Jun 13.

    PMID: 23769849BACKGROUND

Study Officials

  • Morgan Le Guen, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

  • Marc Fischler, MD PhD

    Hôpital Foch

    STUDY CHAIR

  • Frédéric Mercier, MD PhD

    AP-HP Hôpital A. Béclère

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 24, 2017

Study Start

December 12, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)