LaborPP-PERINCT03126136
Pulse Pressure Variability With Position Before EPIdural Analgesia
A study testing Nicom (TM) in people with Labor and Epidural Analgesia, run by Hopital Foch at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Epidural Analgesia
- What is being tested?
- Nicom (TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Dec 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women
- gestational age ≥ 36 weeks
- single eutrophic fetus
- wishing for epidural analgesia
- cervical dilatation less than or equal to 5 cm
- spontaneous labor
Show all 16Show fewer
- 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
- 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%
Who cannot join
- induction of labour using oxytocin before epidural analgesia
- newborn weight > 4kg at birth
Trial locations and contacts
4 sites in 1 country.
France4 sites
AP-HP Hopital Antoine Beclere
Clamart, 92140
Institut Hospitalier Franco-Britannique
Levallois-Perret, 92300
Institut Mutualiste Montsouris
Paris, 75014
Hopital Foch
Suresnes, 92150
About this study
Official title: Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities
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.
- Conditions
- Labor, Epidural Analgesia
- Being tested
- Nicom (TM)
- Keywords
- Fetal heart rate abnormalities, Pregnancy, Epidural analgesia, Pulse pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | Not described Receives: Device: Nicom (TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Secondary outcomes (4)
Fetal heart rate
Fetal heart rate abnormalities occurring during the labor (>1 hour) and requiring an intervention. Comparison of the prognostic performance of pulse pressure and cardiac output to detect fetal heart rate abnormalities
Measured: 4 days
Mode of delivery
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 mode of delivery.
Measured: 4 days
Newborn heart rate, blood pressure, pulse pressure, and cardiac output
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 newborn health status.
Measured: 4 days
Number of patients with hemodynamic abnormalities
Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start12 Dec 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hôpital FochMarc Fischler, MD PhD, Study chair, Hôpital FochFrédéric Mercier, MD PhD, Study chair, AP-HP Hôpital A. Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126136
- Sponsor's protocol ID
- 2016/31
- Other IDs
- 2016- A00846-45
- Acronym
- PP-PERI
- Status last verified
- Aug 2022
- First submitted
- 21 Mar 2017
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23769849
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities
- ClinicalTrials.gov ID
- NCT03126136
- Acronym / sponsor ID
- PP-PERI / 2016/31
- Conditions
- Labor, Epidural Analgesia
- Keywords
- Fetal heart rate abnormalities, Pregnancy, Epidural analgesia, Pulse pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Device: Nicom (TM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- pregnant women
- gestational age ≥ 36 weeks
- single eutrophic fetus
- wishing for epidural analgesia
- cervical dilatation less than or equal to 5 cm
Key exclusion criteria (2 listed)
- induction of labour using oxytocin before epidural analgesia
- newborn weight > 4kg at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicom (TM)Heart rate, arterial pressure and cardiac output measurements (monitor NICOM) performed in the dorsal decubitus position and in the left lateral decubitus | Device | Pregnant women |
Primary outcome
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.
4 secondary outcomes
Fetal heart rate
Time frame: 4 days
Mode of delivery
Time frame: 4 days
Newborn heart rate, blood pressure, pulse pressure, and cardiac output
Time frame: 4 days
Number of patients with hemodynamic abnormalities
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 23769849Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Le Guen, MD principal investigator
Hôpital Foch
Marc Fischler, MD PhD study chair
Hôpital Foch
Frédéric Mercier, MD PhD study chair
AP-HP Hôpital A. Béclère
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicom (TM) in people with Labor and Epidural Analgesia, run by Hopital Foch at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal heart rate (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.