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

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ClinicalTrials.gov Identifier: NCT02964793
Recruitment Status : Unknown
Verified August 2018 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : November 16, 2016
Last Update Posted : September 4, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Small for Gestational Age Other: intervention group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Experimental: Intervention group
The 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
Other: intervention group

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.

No Intervention: Control group
In 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.



Primary Outcome Measures :
  1. Rate detection of FGR [ Time Frame: at birth ]

    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.


Secondary Outcome Measures :
  1. Number of participants presenting the following perinatal outcomes [ Time Frame: at birth ]

    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

  2. Performances of screening policies [ Time Frame: at birth ]
    • 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

  3. Modes of onset of labor and of delivery [ Time Frame: at birth ]
    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

  4. Resource use and costs [ Time Frame: at birth ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964793


Contacts
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Contact: Eric VERSPYCK, PhD Eric.Verspyck@chu-rouen.fr
Contact: astrid Picolet 0476767409 apicolet@chu-grenoble.fr

Locations
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France
Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux Recruiting
Bordeaux, France, 33076
Contact: loic sentilhes    05 56 79 56 79    loicsentilhes@hotmail.com   
Principal Investigator: loic sentilhes, MD         
Department of Obstetrics and Gynecology, Caen University Hospital, Caen Recruiting
Caen, France, 14003
Contact: guillaume benoist    02 31 27 25 32    benoist-gu@chu-caen.fr   
Principal Investigator: guillaume benoist, MD         
Department of Obstetrics and Gynecology, Louis Mourier Hospital, Assistance Publique-Paris Hospitals (APHP) Recruiting
Colombes, France, 92700
Contact: laurent mandelbrot    01 47 60 63 39    laurent.mandelbrot@aphp.fr   
Principal Investigator: Laurent mandelbrot, MD         
Department of Obstetrics and Gynecology, Grenoble University Hospital Recruiting
Grenoble, France, 38000
Contact: pascale hoffmann    04 76 76 92 23    PHoffmann@chu-grenoble.fr   
Principal Investigator: Pascale HOFFMANN, MD         
Department of Obstetrics, Gynecology, and Neonatal Care, Hôpital Jeanne de Flandre, University of Lille Not yet recruiting
Lille, France, 59037
Contact: Véronique Debarge    03 20 44 67 99    Veronique.DEBARGE@CHRU-LILLE.FR   
Principal Investigator: Véronique Debarge, MD         
Department of Obstetrics and Gynecology, North Hospital, Assistance Publique-Marseille Hospitals (APHM), Marseille Not yet recruiting
Marseille, France, 13915
Contact: florence bretelle    04 91 96 46 72    Florence.BRETELLE@ap-hm.fr   
Principal Investigator: florence bretelle, MD         
Department of Obstetrics and Gynecology, Cochin Hospital, Assistance Publique-Paris Hospitals (APHP), Port Royal Recruiting
Paris, France, 75014
Contact: gilles grange    01 58 41 39 39    gilles.grange@aphp.fr   
Principal Investigator: gilles grange, MD         
Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Paris Hospitals (APHP) Recruiting
Paris, France, 75014
Contact: gilles kayem    01 44 73 51 18    gilles.kayem@inserm.fr   
Principal Investigator: Gilles kayem, MD         
Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Paris Hospitals (APHP), Paris Recruiting
Paris, France, 75019
Contact: thomas schmitz    01 40 03 20 00    thomas.schmitz@rdb.aphp.fr   
Principal Investigator: Thomas schmitz, MD         
Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Paris Hospitals (APHP), Kremlin-Bicêtre Recruiting
Paris, France, 94270
Contact: marie-victoire senat    01 45 21 77 64    marie-victoire.senat@aphp.fr   
Principal Investigator: marie-victoire senat, MD         
Department of Obstetrics, Hôpital Poissy-Saint Germain, Versailles-St Quentin University Recruiting
Poissy, France, 78300
Contact: patrick rozenberg    01 39 27 52 57    prozenberg@chi-poissy-st-germain.fr   
Principal Investigator: Patrick rozenberg, MD         
Department of Obstetrics and Gynecology, Rouen University Hospital Not yet recruiting
Rouen, France, 76031
Contact: eric verspyck    02.32.88.56.43    Eric.Verspyck@chu-rouen.fr   
Principal Investigator: Eric verspyck, MD         
Department of Perinatality, Obstetrics and Neonatology, Civil hospice Lyon Recruiting
Saint-Étienne, France, 42055
Contact: Tiphaine Barjat, MD    04 77 82 83 83    tiphaine.barjat@chu-st-etienne.fr   
Principal Investigator: Tiphaine Barjat, MD         
Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg University Hospital, Strasbourg Recruiting
Strasbourg, France, 67200
Contact: bruno langer    03 88 12 75 02    Bruno.Langer@chru-strasbourg.fr   
Principal Investigator: Nicolas SANANES, MD         
Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital Recruiting
Toulouse, France, 31059
Contact: christophe vayssiere    05 67 77 13 79    christophe.vayssiere@gmail.com   
Principal Investigator: christophe vayssiere, MD         
Department of Obstetrics and Gynecology, Tours University Hospital, Recruiting
Tours, France, 37044
Contact: franck perrotin    02 47 47 47 39    franck.perrotin@me.com   
Sponsors and Collaborators
University Hospital, Grenoble
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Anne Ego, PhD University Hospital, Grenoble
Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02964793    
Other Study ID Numbers: 38RC 14.456
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Fetal Growth Restriction
Customised Fetal Weight Reference
Estimated fetal Weight
Symphysis Fundal Height