Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants
HPAG
1 other identifier
interventional
10,000
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
16 active sites
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
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedSeptember 4, 2018
August 1, 2018
1 year
October 19, 2016
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
at birth
Secondary Outcomes (4)
Number of participants presenting the following perinatal outcomes
at birth
Performances of screening policies
at birth
Modes of onset of labor and of delivery
at birth
Resource use and costs
at birth
Study Arms (2)
Intervention group
EXPERIMENTALThe 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
Control group
NO 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Terminations of pregnancy
- Known fibroid uterus or uterine congenital malformations
- Refusal to participate
- Minor patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux
Bordeaux, 33076, France
Department of Obstetrics and Gynecology, Caen University Hospital, Caen
Caen, 14003, France
Department of Obstetrics and Gynecology, Louis Mourier Hospital, Assistance Publique-Paris Hospitals (APHP)
Colombes, 92700, France
Department of Obstetrics and Gynecology, Grenoble University Hospital
Grenoble, 38000, France
Department of Obstetrics, Gynecology, and Neonatal Care, Hôpital Jeanne de Flandre, University of Lille
Lille, 59037, France
Department of Obstetrics and Gynecology, North Hospital, Assistance Publique-Marseille Hospitals (APHM), Marseille
Marseille, 13915, France
Department of Obstetrics and Gynecology, Cochin Hospital, Assistance Publique-Paris Hospitals (APHP), Port Royal
Paris, 75014, France
Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Paris Hospitals (APHP)
Paris, 75014, France
Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Paris Hospitals (APHP), Paris
Paris, 75019, France
Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Paris Hospitals (APHP), Kremlin-Bicêtre
Paris, 94270, France
Department of Obstetrics, Hôpital Poissy-Saint Germain, Versailles-St Quentin University
Poissy, 78300, France
Department of Obstetrics and Gynecology, Rouen University Hospital
Rouen, 76031, France
Department of Perinatality, Obstetrics and Neonatology, Civil hospice Lyon
Saint-Etienne, 42055, France
Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg University Hospital, Strasbourg
Strasbourg, 67200, France
Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital
Toulouse, 31059, France
Department of Obstetrics and Gynecology, Tours University Hospital,
Tours, 37044, France
Related Publications (5)
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.
PMID: 26422365BACKGROUNDEgo 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.
PMID: 26431620BACKGROUNDMonier 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.
PMID: 25346493BACKGROUNDEgo 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.
PMID: 24210714BACKGROUNDEgo 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.
PMID: 16580294BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Ego, PhD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2016
First Posted
November 16, 2016
Study Start
January 1, 2018
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
September 4, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share