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

NCT ID: NCT03224780

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Placenta Accreta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

maternal serum creatine kinase

Biochemical marker

Intervention Type DIAGNOSTIC_TEST

3D Doppler ultrasound

Doppler for placental vessels

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nesreen Abdel Fattah Abdullah Shehata

Assistant Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beni-Suef University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nesreen A Shehata

Role: CONTACT

00201024150605 ext. 02

Hamada Ashry Abd el Wahed

Role: CONTACT

01007240754 ext. 02

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nesreen A Shehata, MD

Role: primary

00201024150605 ext. 02

Hamada A Abdel wahed, MD

Role: backup

01007240754 ext. 02

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9423762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10846790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10203680 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Beni-Suef 13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Netrin-1 and Placenta Accreta
NCT04683562 COMPLETED NA