Clinical trial NCT03224780: Creatine Kinase Versus 3D Doppler for Antenatal Diagnosis of Abnormal Adherent Placenta.
Official title: Creatine Kinase Versus 3D Doppler for Antenatal Diagnosis of Morbidly Adherent Placenta
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: maternal morbidity
timeFrame: from 28 weeks gestation until 24 hours postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Beni-Suef University
Study officials:
References:
citation: 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.
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. doi: 10.1046/j.1469-0705.2000.00083.x. No abstract available.
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. doi: 10.1016/s0002-9378(99)70683-6.