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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
Fetal growth is a dynamic process and its assessment requires multiple observations over time. In most women, placental function is sufficient to allow appropriate fetal growth throughout pregnancy, however in some, it may be not near term or during labor leading to intrapartum compromise Small for gestational age (SGA) is estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile of given reference ranges Fetal growth restriction (FGR) is fetus that has not achieved its growth potential. There are early-onset (< 32 weeks) and late-onset (≥ 32 weeks) types. Late FGR is defined as
- AC/EFW < 3rd centile Or at least two out of three of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC) | The diagnosis of IFC will be made by the treating obstetrician based on abnormal fetal heart rate patterns (classified according to National Institute for Health and Clinical excellence [NICE] guidelines ) (15) or presence of meconium stained liquor. | At time of delivery |
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Inclusion Criteria:
•Women with uncomplicated singleton pregnancy who are planning a vaginal delivery
Exclusion Criteria:
•Multiple pregnancy
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariam Sobhy, MBBCH | Contact | +201095811120 | rrrrgds83@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mariam Sobhy, MBBCH | Assiut University | Principal Investigator |
| Ahmed Aboelhasan, MD | Assiut University | Principal Investigator |
| Moustafa Gadalla, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Hospital, Assiut University Hospital | Asyut | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30104317 | Background | 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. | |
| 32738107 | 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. |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D050497 | Stillbirth |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
|
| 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). |
|
|
| Demographic characteristics of the cohort | Demographic characteristics of the cohort | Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) |
| Estimated fetal weight | An ultrasonographic measurement using Hadlock formula (13) | At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) |
| Birth weight | Birth weight in kilograms | Immediatly after delivery |
| Assiut University |
| Principal Investigator |
| 26909664 | 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. |
| 25346493 | 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. |
| 17721916 | 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. |
| 21343765 | 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. |
| 32557921 | 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. |
| 24931475 | 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. |
| 25446667 | 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. |
| 29227010 | 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. |
| 24945455 | 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. |
| 2192316 | Background | Manning FA. The fetal biophysical profile score: current status. Obstet Gynecol Clin North Am. 1990 Mar;17(1):147-62. |
| 1887021 | 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. |
| 12601831 | Background | Baschat AA, Gembruch U. The cerebroplacental Doppler ratio revisited. Ultrasound Obstet Gynecol. 2003 Feb;21(2):124-7. doi: 10.1002/uog.20. |
| 17901518 | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005313 | Fetal Death |
| D003643 | Death |