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NCT Number: NCT05802251

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

Location status: Recruiting

Location contact

Ayman Abulnor, MD

CONTACT

[email protected]

01223414990

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonographic parameters

Diagnostic Test

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

Primary outcomes

  1. maternal bleeding rate

    Time frame: till delivery

    number of attacks of antepartum hemorrhage

Secondary outcomes

  1. Blood transfusion

    Time frame: till delivery 36 to 37 weeks

    number of PRBCs

  2. Emergency Cesarean section

    Time frame: till delivery 36 to 37 weeks

    severe antepartum hemorrhage requiring delivery

  3. Premature delivery

    Time frame: 37 week's gestation

    before the planned delivery date (before 37 weeks' gestation)

  4. Need for cesarean hysterectomy

    Time frame: during cesarean section

    cesarean hysterectomy due to bleeding or placenta accreta spectrum

  5. Postpartum hemorrhage

    Time frame: Within 2 hours of delivery

    severity of attacks and required further management or blood transfusion

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Abdelrazek, MD

CONTACT

[email protected]

01222393983

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 6, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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