Creatine Kinase Versus 3D Doppler for Antenatal Diagnosis of Abnormal Adherent Placenta.

Creatine Kinase Versus 3D Doppler for Antenatal Diagnosis of Morbidly Adherent Placenta

Placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management.Diagnosis of placenta accreta before delivery minimizes potential maternal or neonatal morbidity and mortality. In this study the researchers will evaluate the role and cost effectiveness of biochemical marker as creatine kinase in comparison with 3D Doppler ultrasound in antenatal diagnosis of placenta accreta and its variants in patients with placenta previa totalis.

Study Overview

• Status: Unknown
• Conditions: Placenta Accreta
• Intervention / Treatment: Diagnostic test: maternal serum creatine kinase; Diagnostic test: 3D Doppler ultrasound

Detailed Description

Abnormal placentation poses a diagnostic and treatment challenge for all providers caring for pregnant women. As one of the leading causes of postpartum hemorrhage, abnormal placentation involves the attachment of placental villi directly to the myometrium with potentially deeper invasion into the uterine wall or surrounding organs. Surgical procedures that disrupt the integrity of uterus, including cesarean section, dilatation and curettage, and myomectomy, have been implicated as key risk factors for placenta accreta(Megier et al., 2000).Prenatal diagnoses of placenta accreta through the use of gray-scale ultrasonography, color Doppler imaging, and magnetic resonance imaging have been reported previously (Chou et al., 1997).

Placenta increta and percreta have rarely been diagnosed antepartum, and ultrasonographic findings may provide the only objective evidence of placenta accreta.A biochemical marker for this condition would therefore be useful (Ophir et al., 1999).It is critical to make the diagnosis before delivery because preoperative planning can significantly decrease blood loss and avoid substantial morbidity associated with placenta accreta (Shih et al., 2009).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Beni-Suef University
    • Contact: Nesreen A Shehata, MD; Phone Number: 02 00201024150605; Email: nesoomar@yahoo.com
    • Contact: Hamada A Abdel wahed, MD; Phone Number: 02 01007240754; Email: hamadaashry2010@yahoo.com
    • Principal Investigator: Nesreen A Shehata, assistant prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

pregnant women with persistent placenta previa (after 28 weeks' gestation) were prospectively enrolled into this study.complete imaging using all diagnostic techniques (gray-scale, color Doppler and 3D power Doppler), and full availability of delivery information. Ultrasound examination was performed using a 3D ultrasound system equipped with a 4-8-MHz transabdominal transducer .• Serum Creatine kinase assessement (reference range is 25-160 U/L).(Ophir et al 1999)

Description

Inclusion Criteria:

- a- Pregnant lady with history of previous cesarean section or hysterotomy. b- Placenta previa with its lower edge covering the scar of previous cesarean section as diagnosed by 2DU/S.

c- Gestational age ranging from 28 wks - Full term.

Exclusion Criteria:

• Women with one or more of the following conditions contributing to rhabdomyolysis:

  1. Crush injury and prolonged surgery.
  2. Embolism, thrombosis, D.V.T., myocardial or brain infarction.
  3. Drug overdose: Antipsychotics, antidepressants, hypnotics, narcotics, alcohol, halothane,salicylates.
  4. Excessive muscle activity as epileptic fit.
  5. Chronic hypertension & PIH
  6. Endocrine disorders: hyper-/hypothyroidism, and diabetes mellitus,history of liver disease or renal disease.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal morbidity	Antepartum and Postpartum maternal complications of morbidly adherent placenta.	from 28 weeks gestation until 24 hours postpartum.

Collaborators and Investigators

• Sponsor: Beni-Suef University

Publications and helpful links

General Publications

• Chou MM, Ho ES. Prenatal diagnosis of placenta previa accreta with power amplitude ultrasonic angiography. Am J Obstet Gynecol. 1997 Dec;177(6):1523-5. doi: 10.1016/s0002-9378(97)70102-9.
• Megier P, Harmas A, Mesnard L, Esperandieu OL, Desroches A. Picture of the month. Antenatal diagnosis of placenta percreta using gray-scale ultrasonography, color and pulsed Doppler imaging. Ultrasound Obstet Gynecol. 2000 Mar;15(3):268. doi: 10.1046/j.1469-0705.2000.00083.x. No abstract available.
• Ophir E, Tendler R, Odeh M, Khouri S, Oettinger M. Creatine kinase as a biochemical marker in diagnosis of placenta increta and percreta. Am J Obstet Gynecol. 1999 Apr;180(4):1039-40. doi: 10.1016/s0002-9378(99)70683-6.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: Beni-Suef 13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No