Pulse Pressure Variability With Position Before EPIdural Analgesia

NCT ID: NCT03126136

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Epidural Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant women

Group Type EXPERIMENTAL

Nicom (TM)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicom (TM)

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


* 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%

Exclusion Criteria

* induction of labour using oxytocin before epidural analgesia
* newborn weight \> 4kg at birth
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Morgan Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Marc Fischler, MD PhD

Role: STUDY_CHAIR

Hôpital Foch

Frédéric Mercier, MD PhD

Role: STUDY_CHAIR

AP-HP Hôpital A. Béclère

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AP-HP Hopital Antoine Beclere

Clamart, , France

Site Status

Institut Hospitalier Franco-Britannique

Levallois-Perret, , France

Site Status

Institut Mutualiste Montsouris

Paris, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23769849 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016- A00846-45

Identifier Type: OTHER

Identifier Source: secondary_id

2016/31

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oxytocin and Fetal Heart Rate Changes
NCT03232918 RECRUITING PHASE4