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RecruitingNCT05802251Updated Jul 30, 2024

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

An observational study in Placenta Previa, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Ain Shams University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
68
Sex
Female
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Placenta Previa

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03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's planned enrollment of 68 is below the median of 100 across 32 observational studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Asymptomatic pregnant women diagnosed with placenta previa between 28 to 37 weeks' gestation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ).
  • Presence of cervical cerclage.
  • Maternal use of vaginla progesterone.
  • History of maternal disease (hypertensive, DM, Cardiac).
  • Fetal malformation or growth restriction
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
68 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testUltrasonographic parameters

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

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What researchers measure

Primary outcomes

  1. maternal bleeding rate

    number of attacks of antepartum hemorrhage

    Time frame: till delivery

Secondary outcomes

  1. Blood transfusion

    number of PRBCs

    Time frame: till delivery 36 to 37 weeks

  2. Emergency Cesarean section

    severe antepartum hemorrhage requiring delivery

    Time frame: till delivery 36 to 37 weeks

  3. Premature delivery

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

    Time frame: 37 week's gestation

  4. Need for cesarean hysterectomy

    cesarean hysterectomy due to bleeding or placenta accreta spectrum

    Time frame: during cesarean section

  5. Postpartum hemorrhage

    severity of attacks and required further management or blood transfusion

    Time frame: Within 2 hours of delivery

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05802251
Responsible party
Maya Abdelrazek (Lecturer, Ain Shams University) — Principal investigator
First posted
Apr 6, 2023
Start date
Jun 1, 2022
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jul 30, 2024

Study contacts

Maya Abdelrazek, MD
Contact
dr_maya89@med.asu.edu.eg
01222393983

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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