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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03224780
• Other study ID #: Beni-Suef 13
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: June 2021

Study information

• Verified date: January 2021
• Source: Beni-Suef University
• Contact: Nesreen A Shehata
• Phone: 00201024150605
• Email: nesoomar[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Diagnostic Test:
• maternal serum creatine kinase
Biochemical marker
• 3D Doppler ultrasound
Doppler for placental vessels

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal morbidity	Antepartum and Postpartum maternal complications of morbidly adherent placenta.	from 28 weeks gestation until 24 hours postpartum.