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

Small for Gestational Age Clinical Trial

— HPAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964793
• Other study ID #: 38RC 14.456
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2018
• Source: University Hospital, Grenoble
• Contact: Eric VERSPYCK, PhD
• Email: Eric.Verspyck[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Small for Gestational Age

Intervention

Other:
• intervention group
The intervention will include clinician training sessions, designed to raise awareness of the importance of monitoring for FGR and standardizing SFH measurements the use of SFH charts and EFW customised charts, built with the same software allowing all information to be recorded on an unique document the use of the EFW values mentioned on US report, to plot EFW on the customised chart 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.

Locations

Country	Name	City	State
France	Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux	Bordeaux
France	Department of Obstetrics and Gynecology, Caen University Hospital, Caen	Caen
France	Department of Obstetrics and Gynecology, Louis Mourier Hospital, Assistance Publique-Paris Hospitals (APHP)	Colombes
France	Department of Obstetrics and Gynecology, Grenoble University Hospital	Grenoble
France	Department of Obstetrics, Gynecology, and Neonatal Care, Hôpital Jeanne de Flandre, University of Lille	Lille
France	Department of Obstetrics and Gynecology, North Hospital, Assistance Publique-Marseille Hospitals (APHM), Marseille	Marseille
France	Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Paris Hospitals (APHP), Kremlin-Bicêtre	Paris
France	Department of Obstetrics and Gynecology, Cochin Hospital, Assistance Publique-Paris Hospitals (APHP), Port Royal	Paris
France	Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Paris Hospitals (APHP), Paris	Paris
France	Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Paris Hospitals (APHP)	Paris
France	Department of Obstetrics, Hôpital Poissy-Saint Germain, Versailles-St Quentin University	Poissy
France	Department of Obstetrics and Gynecology, Rouen University Hospital	Rouen
France	Department of Perinatality, Obstetrics and Neonatology, Civil hospice Lyon	Saint-Étienne
France	Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg University Hospital, Strasbourg	Strasbourg
France	Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital	Toulouse
France	Department of Obstetrics and Gynecology, Tours University Hospital,	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. French. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at birth
Secondary	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	at birth
Secondary	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	at birth
Secondary	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	at birth