NCT03224780

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

July 19, 2017

Last Update Submit

January 30, 2021

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • maternal morbidity

    Antepartum and Postpartum maternal complications of morbidly adherent placenta.

    from 28 weeks gestation until 24 hours postpartum.

Interventions

maternal serum creatine kinaseDIAGNOSTIC_TEST

Biochemical marker

3D Doppler ultrasoundDIAGNOSTIC_TEST

Doppler for placental vessels

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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)

You may qualify if:

  • \- 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.

You may not qualify if:

  • Women with one or more of the following conditions contributing to rhabdomyolysis:
  • Crush injury and prolonged surgery.
  • Embolism, thrombosis, D.V.T., myocardial or brain infarction.
  • Drug overdose: Antipsychotics, antidepressants, hypnotics, narcotics, alcohol, halothane,salicylates.
  • Excessive muscle activity as epileptic fit.
  • Chronic hypertension \& PIH
  • Endocrine disorders: hyper-/hypothyroidism, and diabetes mellitus,history of liver disease or renal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Cairo, Egypt

RECRUITING

Related 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. doi: 10.1016/s0002-9378(97)70102-9.

    PMID: 9423762BACKGROUND

  • 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.

    PMID: 10846790BACKGROUND

  • 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.

    PMID: 10203680BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Nesreen A Shehata

CONTACT

00201024150605nesoomar@yahoo.com

Hamada Ashry Abd el Wahed

CONTACT

01007240754hamadaashry2010@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)