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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

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. Sponsor: University Hospital, Grenoble
   

   Current Primary Outcome: 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.
   
   
   

   Original Primary Outcome: Same as current
   
   

   Current Secondary Outcome:

   • 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
   • 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
   • 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
   • 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
   
   
   

   Original Secondary Outcome: Same as current
   
   Information By: University Hospital, Grenoble
   

   Dates:
   Date Received: October 19, 2016
   Date Started: July 2017
   Date Completion: December 2018
   Last Updated: November 10, 2016
   Last Verified: November 2016