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Small for Gestational AgeHPAGNCT02964793

Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants

A study testing intervention group in people with Small for Gestational Age, run by University Hospital, Grenoble at 16 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and policy makers, and a central question is how to improve the performance of screening during pregnancy in order to provide appropriate care. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Small for Gestational Age
What is being tested?
intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,000 participants
Where
16 sitesFrance
Study dates
1 Jan 2018to 1 Jan 2020
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

  • Mothers will be recruited after delivery if they fulfill the following criteria:
  • Have a singleton pregnancy
  • book before or at 30 weeks GA in the maternity units
  • and deliver in the participating unit

Who cannot join

  • Terminations of pregnancy
  • Known fibroid uterus or uterine congenital malformations
  • Refusal to participate
  • Minor patient

Trial locations and contacts

16 sites in 1 country.

Eric VERSPYCK, PhD contact

Eric.Verspyck@chu-rouen.fr

astrid Picolet contact

0476767409

apicolet@chu-grenoble.fr

16 sites in 1 country

France16 sites, 16 recruiting

  • Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux

    Bordeaux, 33076

    loic sentilhes, 05 56 79 56 79, loicsentilhes@hotmail.com

    loic sentilhes, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Caen University Hospital, Caen

    Caen, 14003

    guillaume benoist, 02 31 27 25 32, benoist-gu@chu-caen.fr

    guillaume benoist, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Louis Mourier Hospital, Assistance Publique-Paris Hospitals (APHP)

    Colombes, 92700

    laurent mandelbrot, 01 47 60 63 39, laurent.mandelbrot@aphp.fr

    Laurent mandelbrot, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Grenoble University Hospital

    Grenoble, 38000

    pascale hoffmann, 04 76 76 92 23, PHoffmann@chu-grenoble.fr

    Pascale HOFFMANN, MD

    Recruiting

  • Department of Obstetrics, Gynecology, and Neonatal Care, Hôpital Jeanne de Flandre, University of Lille

    Lille, 59037

    Véronique Debarge, 03 20 44 67 99, Veronique.DEBARGE@CHRU-LILLE.FR

    Véronique Debarge, MD

    Not yet recruiting

  • Department of Obstetrics and Gynecology, North Hospital, Assistance Publique-Marseille Hospitals (APHM), Marseille

    Marseille, 13915

    florence bretelle, 04 91 96 46 72, Florence.BRETELLE@ap-hm.fr

    florence bretelle, MD

    Not yet recruiting

  • Department of Obstetrics and Gynecology, Cochin Hospital, Assistance Publique-Paris Hospitals (APHP), Port Royal

    Paris, 75014

    gilles grange, 01 58 41 39 39, gilles.grange@aphp.fr

    gilles grange, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Paris Hospitals (APHP)

    Paris, 75014

    gilles kayem, 01 44 73 51 18, gilles.kayem@inserm.fr

    Gilles kayem, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Paris Hospitals (APHP), Paris

    Paris, 75019

    thomas schmitz, 01 40 03 20 00, thomas.schmitz@rdb.aphp.fr

    Thomas schmitz, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Paris Hospitals (APHP), Kremlin-Bicêtre

    Paris, 94270

    marie-victoire senat, 01 45 21 77 64, marie-victoire.senat@aphp.fr

    marie-victoire senat, MD

    Recruiting

  • Department of Obstetrics, Hôpital Poissy-Saint Germain, Versailles-St Quentin University

    Poissy, 78300

    patrick rozenberg, 01 39 27 52 57, prozenberg@chi-poissy-st-germain.fr

    Patrick rozenberg, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Rouen University Hospital

    Rouen, 76031

    eric verspyck, 02.32.88.56.43, Eric.Verspyck@chu-rouen.fr

    Eric verspyck, MD

    Not yet recruiting

  • Department of Perinatality, Obstetrics and Neonatology, Civil hospice Lyon

    Saint-Etienne, 42055

    Tiphaine Barjat, MD, 04 77 82 83 83, tiphaine.barjat@chu-st-etienne.fr

    Tiphaine Barjat, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg University Hospital, Strasbourg

    Strasbourg, 67200

    bruno langer, 03 88 12 75 02, Bruno.Langer@chru-strasbourg.fr

    Nicolas SANANES, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital

    Toulouse, 31059

    christophe vayssiere, 05 67 77 13 79, christophe.vayssiere@gmail.com

    christophe vayssiere, MD

    Recruiting

  • Department of Obstetrics and Gynecology, Tours University Hospital,

    Tours, 37044

    franck perrotin, 02 47 47 47 39, franck.perrotin@me.com

    Recruiting

Other trials in France

About this study

Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and policy makers, and a central question is how to improve the performance of screening during pregnancy in order to provide appropriate care. The recent recommendations and reporting of French results have raised awareness of the need to improve growth screening in France. Based on the existing literature, the hypothesis is that a greater investment in growth monitoring based on a more rigorous interpretation of information available from routinely implemented clinical assessment and ultrasound will allow for significant gains in detection. The current context provides the opportunity to evaluate the application of a training program for serial plotting of Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) on customised charts. This intervention is consistent with French guidelines which support the monthly measurement of SFH, the use of Customised Fetal Weight Reference (CFWR), in particular for referral US (Ultrasound) examinations, and the longitudinal interpretation of growth. These guidelines were recently restated in the clinical practice recommendations issued by the French College of Obstetricians and Gynecologists.

The intervention tested in the trial will include training of professionals for standardization of SFH measurement, introduction of software, and recommendations for growth interpretation and referral examinations. Expected benefits are an increase in antenatal identification of growth restricted fetuses without an increase in the FP rate. Such a program will allow identified Small for Gestational Age (SGA) fetuses to receive appropriate antenatal care. This intervention could double the detection rate of SGA births from 20 to 40%, corresponding to 32 000 infants nationwide annually for whom antenatal care could be improved.

Main objective: To test the effectiveness of the serial plotting of SFH and EFW measures on customised percentile charts supported by provider training, versus standard antenatal care, to improve the detection of FGR. The aim of the investigators is to double rates of antenatal detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th percentile for GA.

Read the detailed description

Type of study Randomized cluster trial

Study objectives:

Main objective : To test the effectiveness of the serial plotting of SFH and EFW measures on customised percentile charts supported by provider training, versus standard antenatal care, to improve the detection of FGR. Our aim is to double rates of antenatal detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th percentile for GA.

Secondary objectives: To measure the impact of screening program on:

  1. Perinatal outcomes: stillbirths and neonatal morbidity and mortality including the risk of severe growth restriction (less than the 3rd percentile).
  2. Rate of false positives and likelihood ratios of screening policies
  3. Modes of onset of labor and of delivery
  4. Resource use and costs : the number of antenatal visits and referrals for ultrasound examinations and their indications will be evaluated

Primary endpoint

Detection of FGR during pregnancy, defined as:

  • The mention of suspected growth restriction in medical charts
  • And either at least one referral for additional US for growth monitoring
  • And/Or a provider indicated delivery for FGR among SGA births, defined as infants with a birthweight below the 10th centile of French CFWR.

Secondary endpoints

  1. Perinatal outcomes: late fetal death, Apgar score<7 at 5 min, pH<7, resuscitation, severe growth restriction (less than the 3rd percentile), admission to a neonatal unit, neonatal convulsions, intra-ventricular hemorrhage, hypoxic-ischemic encephalopathy, death during hospital stay
  2. Rate of false positives (equal to 1-specificity), and likelihood ratios of screening policies and their 95% confidence interval. The rate of FP will be defined as suspected FGR among non-SGA births according to the CFWR.
  3. Modes of onset of labor and of delivery: labor induction and indications, caesarean section and indications (including pre-labor caesarean and caesarean section after onset of labor), provider indicated delivery before 37 and before 39 weeks GA
  4. Resource use and costs : number of antenatal visits, number of referrals for ultrasound examinations and mean number of US per woman, number of umbilical artery Doppler examinations

Inclusion criteria : Singleton pregnancy, Booking before or at 30 weeks GA in the maternity units , Delivery in the participating units Exclusion criteria : Terminations of pregnancy, Known fibroid uterus or uterine congenital malformations, Refusal to participate, Minor patient

HPAG is a cluster randomized trial involving 16 geographically dispersed French maternity units. In the maternity units randomized to the intervention group, a protocol of growth monitoring supported by prior training of healthcare professionals will be implemented for all pregnant women receiving antenatal care in the unit, whatever the GA or medical or obstetrical risk.

The intervention consists only in the standardization of current practices. Clinicians in the intervention maternity units will follow a standardized protocol, and will be asked to measure SFH at each antenatal appointment, collect EFW from the 3rd trimester US, report these values on the chart, and monitor fetal growth according to the protocol guidelines. Practices will remain unchanged in the control group.

After delivery, inclusion and exclusion criteria will be assessed by independent clinical research investigators, probably midwives. All SGA births and non-SGA births according to the French CFWR will be included to answer the main and secondary objectives.

Data collection will be carried out by the referent midwife. Recorded information will include the antenatal care provided, suspicion of FGR, labor and delivery modes, and neonatal outcomes until discharge home. The use of the intervention will also be assessed in the intervention maternity units by recording information on the presence and completeness of customised charts in the medical records.

Sites : 16 French maternity units

Duration : 24 months, including 6 months of inclusions

Number of participants : 10 000 births (625 per maternity unit)

Being tested
intervention group
Keywords
Fetal Growth Restriction, Customised Fetal Weight Reference, Estimated fetal Weight, Symphysis Fundal Height
Medical subject headings
Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intervention groupOther

    The intervention will include

    1. clinician training sessions, designed to raise awareness of the importance of monitoring for FGR and standardizing SFH measurements
    2. the use of SFH charts and EFW customised charts, built with the same software allowing all information to be recorded on an unique document
    3. the use of the EFW values mentioned on US report, to plot EFW on the customised chart
    4. and explicit recommendations about interpretation of longitudinal values of SFH and EFW measurements. If slopes through consecutive plots are not parallel to either of the predicted centile lines (90th, 50th, 10th) on the chart, and either of the centile lines are 'crossed', fetal biometry by ultrasound scan will be recommended.
Study groups in NCT02964793
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention consists in the standardization of current practices. Clinicians in the intervention maternity units will follow a standardized protocol, and will be asked to measure SFH at each antenatal appointment, collect EFW from the 3rd trimester US, report these values on the chart, and monitor fetal growth according to the protocol guidelines
Receives: Other: intervention group
Control groupNo interventionIn the control arm women will benefit from the current routine screening practice for growth failure. The management of pregnancies will remain unchanged. Consultants will be free to monitor growth according to their usual practice. In each maternity unit in the control arm, an information session will be organized on site but its content will be limited to the rational, the objectives of the trial and the study logistics.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate detection of FGR

    The primary outcome will be the detection rate of FGR among SGA births, measured in each arm, defined as:

    • suspected growth restriction mentioned in medical charts
    • AND at least one referral for additional US for growth monitoring
    • AND/OR a provider indicated delivery for FGR among the total number of SGA births, defined as infants with a birthweight below the 10th centile of French CFWR.

    Measured: at birth

Secondary outcomes (4)

  1. Number of participants presenting the following perinatal outcomes

    Perinatal outcomes:

    • late fetal death,
    • Apgar score<7 at 5 min,
    • pH<7,
    • resuscitation,
    • severe growth restriction (less than the 3rd percentile),
    • admission after birth,
    • neonatal convulsions,
    • intra-ventricular hemorrhage,
    • hypoxic-ischemic encephalopathy,
    • death during hospital stay

    Measured: at birth

  2. Performances of screening policies

    • Rate of false positives = equal to 1-specificity = 1 - (True negatives/non-SGA births), where True negatives correspond to non-suspected FGR, and its 95% Confidence Interval
    • PLR (positive likelihood ratios = sensibility / (1 - specificity) and its 95% Confidence Interval
    • NLR (negative likelihood ratios = (1 - sensibility) / specificity and its 95% Confidence Interval

    Measured: at birth

  3. Modes of onset of labor and of delivery

    Modes of onset of labor and of delivery: labor induction and indications, caesarean section and indications (including pre-labor caesarean and caesarean section after onset of labor), provider indicated delivery before 37 and before 39 GA

    Measured: at birth

  4. Resource use and costs

    Impact of screening program on resource use and costs is characterized by :

    • number of antenatal visits per woman,
    • number of referrals for ultrasound examinations per woman
    • number of umbilical artery Doppler examinations per woman

    Measured: at birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2016 (estimated)
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2019 (estimated)
  4. Study completion1 Jan 2020 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964793
Sponsor's protocol ID
38RC 14.456
Acronym
HPAG
Status last verified
Aug 2018
First submitted
19 Oct 2016
Last updated
4 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ego A, Prunet C, Lebreton E, Blondel B, Kaminski M, Goffinet F, Zeitlin J. [Customized and non-customized French intrauterine growth curves. I - Methodology]. J Gynecol Obstet Biol Reprod (Paris). 2016 Feb;45(2):155-64. doi: 10.1016/j.jgyn.2015.08.009. Epub 2015 Sep 28. French.

    PubMed 26422365

  • Ego A, Prunet C, Blondel B, Kaminski M, Goffinet F, Zeitlin J. [Customized and non-customized French intrauterine growth curves. II - Comparison with existing curves and benefits of customization]. J Gynecol Obstet Biol Reprod (Paris). 2016 Feb;45(2):165-76. doi: 10.1016/j.jgyn.2015.08.008. Epub 2015 Oct 1. French.

    PubMed 26431620

  • Monier I, Blondel B, Ego A, Kaminiski M, Goffinet F, Zeitlin J. Poor effectiveness of antenatal detection of fetal growth restriction and consequences for obstetric management and neonatal outcomes: a French national study. BJOG. 2015 Mar;122(4):518-27. doi: 10.1111/1471-0528.13148. Epub 2014 Oct 27.

    PubMed 25346493

  • Ego A. [Definitions: small for gestational age and intrauterine growth retardation]. J Gynecol Obstet Biol Reprod (Paris). 2013 Dec;42(8):872-94. doi: 10.1016/j.jgyn.2013.09.012. Epub 2013 Nov 7. French.

    PubMed 24210714

  • Ego A, Subtil D, Grange G, Thiebaugeorges O, Senat MV, Vayssiere C, Zeitlin J. Customized versus population-based birth weight standards for identifying growth restricted infants: a French multicenter study. Am J Obstet Gynecol. 2006 Apr;194(4):1042-9. doi: 10.1016/j.ajog.2005.10.816.

    PubMed 16580294

Questions about this trial

What is this clinical trial studying?

A study testing intervention group in people with Small for Gestational Age, run by University Hospital, Grenoble at 16 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eric VERSPYCK, PhD (Eric.Verspyck@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate detection of FGR (time frame: at birth). 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 NCT02964793, which also lists 5 linked publications.

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 4 Sep 2018.

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