Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio

NCT04640467 | Unknown

• 1 other identifier: CPR in late growth restriction
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the screening performance of CPR and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (CS or instrumental) for intrapartum fetal distress in low-risk pregnancies

Conditions

Fetal Growth Retardation; Stillbirth; Neonatal Respiratory Failure; Neonatal Death

Keywords

Cerebroplacental ratio; Fetal growth restriction; Term pregnancy; Doppler ultrasound

Outcome Measures

Primary Outcomes (1)

• A composite of adverse neonatal outcomes

  Apgar score ≤7 at 5 min or resuscitation with intubation, chest compressions or medication, admission to NICU ≥ 48 hours or hypoxic ischemic encephalopathy or cerebral palsy or stillbirth or neonatal death within 28 days

  Up to 48 hours After delivery

Secondary Outcomes (4)

• Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC)

  At time of delivery

• Demographic characteristics of the cohort

  Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)

• Estimated fetal weight

  At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)

• Birth weight

  Immediatly after delivery

Study Arms (1)

Pregnant women

Women with uncomplicated singleton pregnancy who are planning a vaginal delivery, gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) and cephalic presentation

Diagnostic Test: Biophsical profile; Diagnostic Test: Cerebroplacental ratio

Interventions

Biophsical profile DIAGNOSTIC_TEST

There are five components measured during the biophysical examination. A score of 2 points is given for each component that meets criteria. The test is continued until all criteria are met or 30 minutes have elapsed. The points are then added for a possible maximum score of 10. A total score of 10 out of 10 or 8 out of 10 with normal fluid is considered normal. A score of 6 is considered equivocal, and a score of 4 or less is abnormal.

Also known as: BPP

Pregnant women

Cerebroplacental ratio DIAGNOSTIC_TEST

CPR is the ratio of the Middle Cerebral Artery Pulsatility Index (MCA PI) to the Umbilical Artery Pulsatility Index (UA PI). The pulsatility indices will be measured from an automated trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The angle of insonation will be as close to zero degrees as possible. The UA PI will be recorded from a free-floating section of cord, and the MCA PI will be obtained from the proximal third of the vessel (10, 14).

Also known as: CPR

Pregnant women

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with uncomplicated singleton pregnancy who are planning a vaginal delivery. Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) with cephalic presentation

You may qualify if:

• Women with uncomplicated singleton pregnancy who are planning a vaginal delivery
• Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
• Cephalic presentation

You may not qualify if:

• Multiple pregnancy
• known SGA fetus.
• Medical disorders with pregnancy: diabetes mellitus, hypertension, pre-eclampsia
• Known fetal anomaly or aneuploidy or stillbirth.
• Any contraindication of vaginal delivery eg. placenta previa.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women's Health Hospital, Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (15)

• Sherrell H, Clifton V, Kumar S. Predicting intrapartum fetal compromise at term using the cerebroplacental ratio and placental growth factor levels (PROMISE) study: randomised controlled trial protocol. BMJ Open. 2018 Aug 13;8(8):e022567. doi: 10.1136/bmjopen-2018-022567.

  PMID: 30104317 BACKGROUND

• Lees CC, Stampalija T, Baschat A, da Silva Costa F, Ferrazzi E, Figueras F, Hecher K, Kingdom J, Poon LC, Salomon LJ, Unterscheider J. ISUOG Practice Guidelines: diagnosis and management of small-for-gestational-age fetus and fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. doi: 10.1002/uog.22134. No abstract available.

  PMID: 32738107 BACKGROUND

• Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884.

  PMID: 26909664 BACKGROUND

• 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.

  PMID: 25346493 BACKGROUND

• Ebbing C, Rasmussen S, Kiserud T. Middle cerebral artery blood flow velocities and pulsatility index and the cerebroplacental pulsatility ratio: longitudinal reference ranges and terms for serial measurements. Ultrasound Obstet Gynecol. 2007 Sep;30(3):287-96. doi: 10.1002/uog.4088.

  PMID: 17721916 BACKGROUND

• Cruz-Martinez R, Figueras F, Hernandez-Andrade E, Oros D, Gratacos E. Fetal brain Doppler to predict cesarean delivery for nonreassuring fetal status in term small-for-gestational-age fetuses. Obstet Gynecol. 2011 Mar;117(3):618-626. doi: 10.1097/AOG.0b013e31820b0884.

  PMID: 21343765 BACKGROUND

• Stampalija T, Thornton J, Marlow N, Napolitano R, Bhide A, Pickles T, Bilardo CM, Gordijn SJ, Gyselaers W, Valensise H, Hecher K, Sande RK, Lindgren P, Bergman E, Arabin B, Breeze AC, Wee L, Ganzevoort W, Richter J, Berger A, Brodszki J, Derks J, Mecacci F, Maruotti GM, Myklestad K, Lobmaier SM, Prefumo F, Klaritsch P, Calda P, Ebbing C, Frusca T, Raio L, Visser GHA, Krofta L, Cetin I, Ferrazzi E, Cesari E, Wolf H, Lees CC; TRUFFLE-2 Group. Fetal cerebral Doppler changes and outcome in late preterm fetal growth restriction: prospective cohort study. Ultrasound Obstet Gynecol. 2020 Aug;56(2):173-181. doi: 10.1002/uog.22125.

  PMID: 32557921 BACKGROUND

• Crimmins S, Desai A, Block-Abraham D, Berg C, Gembruch U, Baschat AA. A comparison of Doppler and biophysical findings between liveborn and stillborn growth-restricted fetuses. Am J Obstet Gynecol. 2014 Dec;211(6):669.e1-10. doi: 10.1016/j.ajog.2014.06.022. Epub 2014 Jun 12.

  PMID: 24931475 BACKGROUND

• Khalil AA, Morales-Rosello J, Morlando M, Hannan H, Bhide A, Papageorghiou A, Thilaganathan B. Is fetal cerebroplacental ratio an independent predictor of intrapartum fetal compromise and neonatal unit admission? Am J Obstet Gynecol. 2015 Jul;213(1):54.e1-54.e10. doi: 10.1016/j.ajog.2014.10.024. Epub 2014 Oct 18.

  PMID: 25446667 BACKGROUND

• Bligh LN, Alsolai AA, Greer RM, Kumar S. Prelabor screening for intrapartum fetal compromise in low-risk pregnancies at term: cerebroplacental ratio and placental growth factor. Ultrasound Obstet Gynecol. 2018 Dec;52(6):750-756. doi: 10.1002/uog.18981.

  PMID: 29227010 BACKGROUND

• Practice bulletin no. 145: antepartum fetal surveillance. Obstet Gynecol. 2014 Jul;124(1):182-192. doi: 10.1097/01.AOG.0000451759.90082.7b. No abstract available.

  PMID: 24945455 BACKGROUND

• Manning FA. The fetal biophysical profile score: current status. Obstet Gynecol Clin North Am. 1990 Mar;17(1):147-62.

  PMID: 2192316 BACKGROUND

• Hadlock FP, Harrist RB, Martinez-Poyer J. In utero analysis of fetal growth: a sonographic weight standard. Radiology. 1991 Oct;181(1):129-33. doi: 10.1148/radiology.181.1.1887021.

  PMID: 1887021 BACKGROUND

• Baschat AA, Gembruch U. The cerebroplacental Doppler ratio revisited. Ultrasound Obstet Gynecol. 2003 Feb;21(2):124-7. doi: 10.1002/uog.20.

  PMID: 12601831 BACKGROUND

• Kenyon S, Ullman R, Mori R, Whittle M. Care of healthy women and their babies during childbirth: summary of NICE guidance. BMJ. 2007 Sep 29;335(7621):667-8. doi: 10.1136/bmj.39322.703380.AD. No abstract available.

  PMID: 17901518 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation; Stillbirth; Perinatal Death

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Death; Death

Study Officials

• Mariam Sobhy, MBBCH

  Assiut University

  PRINCIPAL INVESTIGATOR

• Ahmed Aboelhasan, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Moustafa Gadalla, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Sobhy, MBBCH

CONTACT

+201095811120; rrrrgds83@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics & Gynecology

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: November 23, 2020
• Study Start: February 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

EG (1)