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

August 31, 2018 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux
        • Contact:
        • Principal Investigator:
          • Loic Sentilhes, MD
      • Caen, France, 14003
        • Recruiting
        • Department of Obstetrics and Gynecology, Caen University Hospital, Caen
        • Contact:
        • Principal Investigator:
          • guillaume benoist, MD
      • Colombes, France, 92700
        • Recruiting
        • Department of Obstetrics and Gynecology, Louis Mourier Hospital, Assistance Publique-Paris Hospitals (APHP)
        • Contact:
        • Principal Investigator:
          • Laurent mandelbrot, MD
      • Grenoble, France, 38000
        • Recruiting
        • Department of Obstetrics and Gynecology, Grenoble University Hospital
        • Contact:
        • Principal Investigator:
          • Pascale HOFFMANN, MD
      • Lille, France, 59037
        • Not yet recruiting
        • Department of Obstetrics, Gynecology, and Neonatal Care, Hôpital Jeanne de Flandre, University of Lille
        • Contact:
        • Principal Investigator:
          • Véronique Debarge, MD
      • Marseille, France, 13915
        • Not yet recruiting
        • Department of Obstetrics and Gynecology, North Hospital, Assistance Publique-Marseille Hospitals (APHM), Marseille
        • Contact:
        • Principal Investigator:
          • florence bretelle, MD
      • Paris, France, 75014
        • Recruiting
        • Department of Obstetrics and Gynecology, Cochin Hospital, Assistance Publique-Paris Hospitals (APHP), Port Royal
        • Contact:
        • Principal Investigator:
          • gilles grange, MD
      • Paris, France, 75014
        • Recruiting
        • Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Paris Hospitals (APHP)
        • Contact:
        • Principal Investigator:
          • Gilles kayem, MD
      • Paris, France, 75019
        • Recruiting
        • Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Paris Hospitals (APHP), Paris
        • Contact:
        • Principal Investigator:
          • Thomas schmitz, MD
      • Paris, France, 94270
        • Recruiting
        • Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Paris Hospitals (APHP), Kremlin-Bicêtre
        • Contact:
        • Principal Investigator:
          • marie-victoire senat, MD
      • Poissy, France, 78300
        • Recruiting
        • Department of Obstetrics, Hôpital Poissy-Saint Germain, Versailles-St Quentin University
        • Contact:
        • Principal Investigator:
          • Patrick rozenberg, MD
      • Rouen, France, 76031
        • Not yet recruiting
        • Department of Obstetrics and Gynecology, Rouen University Hospital
        • Contact:
        • Principal Investigator:
          • Eric verspyck, MD
      • Saint-Étienne, France, 42055
        • Recruiting
        • Department of Perinatality, Obstetrics and Neonatology, Civil hospice Lyon
        • Contact:
        • Principal Investigator:
          • Tiphaine BARJAT, MD
      • Strasbourg, France, 67200
        • Recruiting
        • Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg University Hospital, Strasbourg
        • Contact:
        • Principal Investigator:
          • Nicolas SANANES, MD
      • Toulouse, France, 31059
        • Recruiting
        • Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital
        • Contact:
        • Principal Investigator:
          • Christophe VAYSSIERE, MD
      • Tours, France, 37044
        • Recruiting
        • Department of Obstetrics and Gynecology, Tours University Hospital,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at birth
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
at birth
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
at birth
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
at birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Anne Ego, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC 14.456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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