NCT06248385

Brief Summary

The aim of our study is to determine correlation between lower placental edge thickness measured by ultrasound and gestational age at delivery and predict the risk of emergency preterm birth in patients having placenta previa accreta.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

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

First Submitted

Initial submission to the registry

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 6, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

January 31, 2024

Last Update Submit

August 3, 2024

Conditions

Placenta Accreta

Keywords

Placental edge thicknessPlacenta AccretaPreterm delivery

Outcome Measures

Primary Outcomes (1)

  • Lower placental edge thickness measurements by ultrasound in patients having placenta previa accreta.

    Lower placental edge thickness measurements by ultrasound in patients having placenta previa accreta until delivery will occur.

    Baseline

Secondary Outcomes (6)

  • Type of cesarean delivery

    Baseline

  • Gestational age at delivery.

    Baseline

  • Antepartum bleeding, post-partum hemorrhage .

    Baseline

  • Need for Cesarean hysterectomy

    Baseline

  • Peripartum blood transfusion

    Baseline

  • +1 more secondary outcomes

Interventions

2D ultrasoundDEVICE

2D TVUS

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will be carried out on 50 women with a singleton pregnancy, between 28-36 weeks, with placenta previa accreta by suspected sonographic examination.

You may qualify if:

  • Single, viable gestations. Gestational age \>28 weeks, \< 36 weeks.
  • Confirmed diagnosis of placenta previa accreta when the placenta lies directly over the internal os based on ultrasound features among RCOG criteria as follows) RCOG,2019):
  • D greyscale signs: loss of myometrial interface or retroplacental clear space, reduced myometrial thickness, intra-placental blood flow and intra-placental lacunae.
  • D color Doppler signs: intra-placental blood flow, the presence of altered blood flow in the retroplacental space and aberrant vessels crossing between placental surfaces.
  • First time of diagnosis of placenta previa accreta is 28-30 weeks. Previous one or more cesarean sections.

You may not qualify if:

  • Maternal medical co-morbidities like diabetes and hypertension. Patients with bleeding disorders or anticoagulant therapy. Over distended uterus e.g.: multiple gestation, polyhydramnios, fetal macrosomia(\>4.5kg).
  • Fetal anomalies or fetal growth restriction. Emergency cesarean section due to fetal distress. Rupture of membranes, intra-amniotic infection and fever during admission (\>38 °C).
  • History of cervical cerclage or cervical cone biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospitals

Cairo, Egypt

RECRUITING

Related Publications (3)

  • Syed W, Liaqat N, Naseeb G, Khattak SM. Relationship of placental edge thickness and cervical length to gestational age at delivery in patients with placenta previa. Pak J Med Sci. 2022 May-Jun;38(5):1349-1352. doi: 10.12669/pjms.38.5.5097.

    PMID: 35799721BACKGROUND

  • Zaitoun MM, El Behery MM, Abd El Hameed AA, Soliman BS. Does cervical length and the lower placental edge thickness measurement correlates with clinical outcome in cases of complete placenta previa? Arch Gynecol Obstet. 2011 Oct;284(4):867-73. doi: 10.1007/s00404-010-1737-1. Epub 2010 Nov 27.

    PMID: 21113721BACKGROUND

  • Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.

    PMID: 30260097BACKGROUND

MeSH Terms

Conditions

Placenta AccretaPremature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta DiseasesObstetric Labor, Premature

Study Officials

  • Sherif Fathi, MD

    World Health Organization

    STUDY DIRECTOR

Central Study Contacts

Heba Eid, M.Sc.

CONTACT

+201069395117hebaeid2020@outlook.com

Alaa Said, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 8, 2024

Study Start

February 12, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

August 6, 2024

Record last verified: 2024-01

Locations

EG(1)