Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study

NCT ID: NCT05802251

Last Updated: 2024-07-30

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

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Recruitment Status

RECRUITING

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-08-31

Brief Summary

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The aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa.

Detailed Description

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The incidence of placenta previa is 3-5 per 1000 pregnancies worldwide and is still rising because of increased maternal age, parity, cesarean section rates, assisted reproductive technology, maternal smoking with the widespread use of transvaginal ultrasound. antepartum hemorrhage is an important cause of maternal and neonatal morbidity and mortality in pregnant women with placenta previa. However, the epidemiological characteristics are not completely understood. this study aims at evaluating the sonographic findings in asymptomatic women with placenta previa as cervical length, placenta thickness and distance from cervix to placental edge to recommend management for in-patients versus out-patient antenatal care and early planned hospital admission and delivery for women at high risk of antepartum hemorrhage and preterm cesarean section and hysterectomy for life threatening antepartum hemorrhage.

Conditions

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Placenta Previa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasonographic parameters

cervical length. placental thickness. distance placental edge from internal os of the cervix

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Asymptomatic women diagnosed with placenta previa according to RCOG (GTG No. 27a, 2018): placenta lies directly over the internal os for pregnancies more than 16 weeks' gestation on transabdominal or transvaginal scanning.
* Gestational age between 28 till 37 weeks' gestation (as delivery should be considered between 36 and 37 weeks of gestation for women presenting with uncomplicated placenta previa)

Exclusion Criteria

* Multiple pregnancies.
* Threatened preterm labor or preterm rupture of membranes.
* History of bleeding in the current pregnancy.
* Polyhydraminos (AFI \> 25 cm).
* History of cervical surgery (cone biopsy).
* Presence of cervical cerclage.
* Maternal use of vaginla progesterone.
* History of maternal disease (hypertensive, DM, Cardiac).
* Fetal malformation or growth restriction
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Maya Abdelrazek

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maya Abdelrazek, MD

Role: CONTACT

01222393983

Facility Contacts

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Ayman Abulnor, MD

Role: primary

01223414990

Other Identifiers

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MD 172 2022

Identifier Type: -

Identifier Source: org_study_id

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