Pulmonary Artery Doppler and Neonatal Outcome in Placenta Accreta Spectrum Patients

NCT04911322 | Completed

• 1 other identifier: PAS disorders
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

To correlate ultrasonographic markers of fetal lung maturity including Pulmonary artery Doppler indices in the late preterm and early term in placenta accreta spectrum patients with neonatal outcome.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome.

  (At/Et) ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome

  Baseline

Secondary Outcomes (11)

• The pulsatility index (PI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome.

  Baseline

• The resistance index (RI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome

  Baseline

• The systolic to diastolic ratio (S/D) of the fetal pulmonary artery Doppler in neonates with good and poor outcome

  Baseline

• The peak systolic velocity (PSV) of the fetal pulmonary artery Doppler in neonates with good and poor outcome

  Baseline

• Optimal timing of delivery in PAS for best neonatal outcome

  baseline

Interventions

ultrasonography DEVICE

A full obstetric ultrasound scan will be performed to assess signs of placental invasion, to document fetal biometry, estimated fetal weight, amniotic fluid index, assess fetal lung maturity parameters as pulmonary artery Doppler waveforms, amniotic fluid free floating particles, bowel echogenicity, fetal epiphyseal ossific centers, liver/lung echogenicity and kidney length. Pulmonary artery Doppler: Fetal echocardiography will be done. Pulmonary artery Doppler flow waveforms, including pulsatility index, resistance index, systolic-to-diastolic ratio, peak systolic velocity, and acceleration time to ejection time ratio will be measured in the main pulmonary artery.

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with placenta accreta spectrum with singleton pregnancy undergoing cesarean delivery in Kasr Alainy hospital.

You may qualify if:

• Age: 18-42 years old
• Patients who will be diagnosed with placenta accreta spectrum preoperatively according to (ACOG 2018), (Jauniaux et al., 2018 a), (Jauniaux et al., 2018 b)
• Those who will undergo elective or emergency cesarean.
• With gestational age: 34 0/7 - 38 6/7 weeks
• Under the effect of general anesthesia

You may not qualify if:

• Multifetal pregnancy
• Intrauterine fetal death
• Intrauterine growth restriction (IUGR) which is defined as a rate of fetal growth that is less than normal for the growth potential of that specific infant
• Diabetes with pregnancy either gestational or overt which is defined as any degree of glucose intolerance with an onset or first recognition during pregnancy
• Pregnancy induced hypertension defined as either systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg. It is classified as one of four conditions: preexisting hypertension, gestational hypertension, preeclampsia, preexisting hypertension with superimposed preeclampsia
• Premature rupture of membranes
• BMI above 40 due to technical difficulties to obtain accurate measures
• Narcotic usage during anesthesia before fetal delivery
• Major congenital fetal anomalies whether diagnosed before or after delivery
• Maternal fever more than 37.4 degree
• Emergent cases presenting with fetal distress (bradycardia will be defined as fetal heart rate \< 110 beat per minute)
• Patients who have not completed the course of antenatal corticosteroids according to (RCOG 2010).
• Intraoperative spontaneous separation of the placenta

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralainy Cairo University

Giza, Egypt

Location

Related Publications (18)

• American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric Care Consensus No. 7: Placenta Accreta Spectrum. Obstet Gynecol. 2018 Dec;132(6):e259-e275. doi: 10.1097/AOG.0000000000002983.

  PMID: 30461695 BACKGROUND

• Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.

  PMID: 26849801 BACKGROUND

• Buchanan TA, Xiang AH. Gestational diabetes mellitus. J Clin Invest. 2005 Mar;115(3):485-91. doi: 10.1172/JCI24531.

  PMID: 15765129 BACKGROUND

• Hobson SR, Kingdom JC, Murji A, Windrim RC, Carvalho JCA, Singh SS, Ziegler C, Birch C, Frecker E, Lim K, Cargill Y, Allen LM. No. 383-Screening, Diagnosis, and Management of Placenta Accreta Spectrum Disorders. J Obstet Gynaecol Can. 2019 Jul;41(7):1035-1049. doi: 10.1016/j.jogc.2018.12.004.

  PMID: 31227057 BACKGROUND

• Creanga AA, Bateman BT, Butwick AJ, Raleigh L, Maeda A, Kuklina E, Callaghan WM. Morbidity associated with cesarean delivery in the United States: is placenta accreta an increasingly important contributor? Am J Obstet Gynecol. 2015 Sep;213(3):384.e1-11. doi: 10.1016/j.ajog.2015.05.002. Epub 2015 May 5.

  PMID: 25957019 BACKGROUND

• Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4.

  PMID: 19191778 BACKGROUND

• Hornberger LK, Sahn DJ. Rhythm abnormalities of the fetus. Heart. 2007 Oct;93(10):1294-300. doi: 10.1136/hrt.2005.069369. No abstract available.

  PMID: 17890709 BACKGROUND

• Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.

  PMID: 30260097 BACKGROUND

• Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.

  PMID: 29405319 BACKGROUND

• Kim SM, Park JS, Norwitz ER, Hwang EJ, Kang HS, Park CW, Jun JK. Acceleration time-to-ejection time ratio in fetal pulmonary artery predicts the development of neonatal respiratory distress syndrome: a prospective cohort study. Am J Perinatol. 2013 Nov;30(10):805-12. doi: 10.1055/s-0032-1333132. Epub 2013 Jan 4.

  PMID: 23292917 BACKGROUND

• Mahony BS, Bowie JD, Killam AP, Kay HH, Cooper C. Epiphyseal ossification centers in the assessment of fetal maturity: sonographic correlation with the amniocentesis lung profile. Radiology. 1986 May;159(2):521-4. doi: 10.1148/radiology.159.2.3515425.

  PMID: 3515425 BACKGROUND

• Mammaro A, Carrara S, Cavaliere A, Ermito S, Dinatale A, Pappalardo EM, Militello M, Pedata R. Hypertensive disorders of pregnancy. J Prenat Med. 2009 Jan;3(1):1-5.

  PMID: 22439030 BACKGROUND

• McCowan LM, Figueras F, Anderson NH. Evidence-based national guidelines for the management of suspected fetal growth restriction: comparison, consensus, and controversy. Am J Obstet Gynecol. 2018 Feb;218(2S):S855-S868. doi: 10.1016/j.ajog.2017.12.004.

  PMID: 29422214 BACKGROUND

• Seoud MA, Nasr R, Berjawi GA, Zaatari GS, Seoud TM, Shatila AS, Mirza FG. Placenta accreta: Elective versus emergent delivery as a major predictor of blood loss. J Neonatal Perinatal Med. 2017;10(1):9-15. doi: 10.3233/NPM-1622.

  PMID: 28304318 BACKGROUND

• Spong CY, Mercer BM, D'Alton M, Kilpatrick S, Blackwell S, Saade G. Timing of indicated late-preterm and early-term birth. Obstet Gynecol. 2011 Aug;118(2 Pt 1):323-333. doi: 10.1097/AOG.0b013e3182255999.

  PMID: 21775849 BACKGROUND

• Varner S, Sherman C, Lewis D, Owens S, Bodie F, McCathran CE, Holliday N. Amniocentesis for fetal lung maturity: will it become obsolete? Rev Obstet Gynecol. 2013;6(3-4):126-34.

  PMID: 24826202 BACKGROUND

• Warshak CR, Ramos GA, Eskander R, Benirschke K, Saenz CC, Kelly TF, Moore TR, Resnik R. Effect of predelivery diagnosis in 99 consecutive cases of placenta accreta. Obstet Gynecol. 2010 Jan;115(1):65-69. doi: 10.1097/AOG.0b013e3181c4f12a.

  PMID: 20027036 BACKGROUND

• Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Gyamfi-Bannerman C. Society for Maternal-Fetal Medicine (SMFM) Consult Series #44: Management of bleeding in the late preterm period. Am J Obstet Gynecol. 2018 Jan;218(1):B2-B8. doi: 10.1016/j.ajog.2017.10.019. Epub 2017 Oct 25.

  PMID: 29079144 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ahmed H El Sawaf, MD

  Cairo University

  STUDY DIRECTOR

• Tarek M El Husseiny, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nominated demonstrator of Obstetrics and Gynecology, Cairo University

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 3, 2021
• Study Start: August 15, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

EG (1)