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Not yet recruitingNCT06717997Updated Dec 5, 2024

The Placental Thickness and Pregnancy Outcomes in Placenta Previa Women

An interventional study of ultrasound in Placenta Accreta, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

Placenta previa is the placenta overlying the cervical os. Placenta previa is about 1 in 200 pregnancies. The risk factors are the increasing rate of cesarean section and previous uterine surgery. Placenta previa is associated with many adverse complications; the most serious one is related to maternal hemorrhage. The diagnosis of placenta previa is done by trans-abdominal and trans-vaginal ultrasonography, which can document the placental edge's relationship to the internal os. Placenta accreta spectrum disorder is defined when trophoblastic invades the myometrium. The Placenta accreta spectrum can be categorized as: placenta accreta, placenta increta, and placenta percreta.

The clinical utility of placental thickness is an area of ongoing research in placenta previa. Prior studies have demonstrated an association between mid-trimester placental thickness and placenta accreta spectrum. Despite the presence of many studies in characterizing placental thickness, most studies have focused primarily on the placental accreta spectrum lacking information about other fetal and maternal complications. Symptomatic (bleeding) placenta previa is associated with increased maternal and neonatal morbidity and mortality. In addition; the mechanism that involves bleeding is unclear. It is usually related to uterine contractions, cervical effacement, and dilation leading to separation of the placenta from the underlying decidua.

02

Conditions studied

  • Placenta Accreta

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03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 140 is above the median of 70 across 67 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  1. Pregnant women from 32-34 weeks.
  2. Pregnant women with singleton pregnancy.
  3. Women with placenta previa.
  4. Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
  5. Women without any medical disorders.
  6. Women should be living in a nearby area to make follow-up and early transportation is reasonably possible.

Exclusion criteria

Exclusion Criteria:

  1. Women with severe bleeding necessitate immediate delivery.
  2. Women with confirmed fetal malformation.
  3. If associated with abruptio placentae.
  4. Women who will refuse to participate.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Other
    Normal placental thickness women

    Other: ultrasound

  • Other
    High placental thickness women

    Other: ultrasound

Interventions

  • Otherultrasound

    The placenta thickness will be performed on transabdominal images obtained in a longitudinal plane. Three measurements will be performed at the thickest portion of the placenta. The average of these three measurements was used for statistical analysis. The cohorts will be classified into 1) thick placenta (\>4 cm) and average placenta (2-4 cm).

06

What researchers measure

Primary outcomes

  1. number of women with placenta accreta

    Time frame: 3 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Jan 2027, 24 months later.

Of 45 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 24 months is above that.

Counting every sponsor, half of 45 studies reached it within 19 months; a quarter within 12 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2024
First posted
Dec 5, 2024
StartEst.
Jan 2025
Primary completionEst.
Jan 2027
CompletionEst.
Mar 2027
Last update
Dec 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06717997
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Assistant Professor, Assiut University) — Principal investigator
First posted
Dec 5, 2024
Start date
Jan 2025 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Dec 5, 2024

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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