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CompletedNCT05407571Updated Sep 8, 2023

Echogenic Amniotic Fluid on Perinatal Outcome

An interventional study of Significance of Echogenic Amniotic Fluid on Perinatal Outcome in Amniotic Fluid; Disorder, sponsored by Egymedicalpedia. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

Amniotic fluid is the liquid that surrounds a developing fetus in the amniotic sac and is usually clear to pale yellow in color. Amniotic fluid composition is complex with many maternal and fetal constituents. It is mainly formed from fetal plasma volume, fetal urine, fetal respiratory system, gastrointestinal tract, umbilical cord, and fetal surface of the placenta. The composition of the Amniotic fluid changes with the gestational age with an average pH of 7.2 and specific gravity of 1.0069-1.008

Read the detailed description

The sonographic appearance of amniotic fluid has been described as both anechoic and echogenic. The clinical significance of echogenic amniotic fluid remains undetermined. Increased echogenicity of the amniotic fluid may represent meconium. The presence of echogenic amniotic fluid at term on sonography is uncommon. The presence of meconium, blood or vernix caseosa in amniotic fluid may cause echogenicity.

The existence of meconium in amniotic fluid raises concerns about fetal well-being, the ability of the fetus to tolerate labor, or, most importantly, the risk of fetal/ neonatal demise . For these reasons, obstetricians tend to increase the frequency of prenatal visits to assess fetal well-being with non-stress tests or biophysical profiles (when there is no other indication for them), and even to induce labor when amniotic fluid is echogenic. On the other hand, elective induction of labor at term carries risks such as increased rate of cesarean section, uterine rupture or unexpected neonatal prematurity.

The presence of echogenic and dense particles in amniotic fluid on the ultrasound scan mimicking the view of a snow-storm in the third-trimester pregnant women is a cause of concern in antenatal management. that high-density intra-amniotic particles were possibly related to vernix caseosa, intra-amniotic bleeding, and meconium.

Although the most commonly reported cause of particulate or echogenic amniotic fluid was vernix caseosa, the reason for concern for the obstetricians in the case of intra-amniotic particles is its potential relationship with meconium as well as fetal compromise

. Free-floating dense particles in the amniotic fluid were also related to lung maturity and it was hypothesized that the source of these particles could be different in each trimester. The concerns for the presence of meconium-stained amniotic fluid in the case of an amniotic sludge may lead the obstetricians to elective induction in term pregnancies before the labor starts spontaneously which also increases the potential complications and caesarean rate

02

Conditions studied

  • Amniotic Fluid; Disorder
03

In context

Lead sponsor

Egymedicalpedia is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

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
Yes

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 aged between 20, 35 years.
  2. Near or Full-term pregnant women admitted for delivery.
  3. Reliable date of LMP.
  4. Delivered vaginally after spontaneous onset of labor or CS.

Exclusion criteria

Exclusion Criteria:

  1. Fetal congenital anomaly by ultrasound (anencephaly\& Down syndrome), IUGR or macrosomic fetuses.
  2. Multifetal pregnancy.
  3. Maternal co-morbidity (Diabetes mellitus, hypertension, cardiac diseases, renal diseases \& hemorrhagic diseases) .
  4. Maternal infection (Toxoplasmosis, Varicella zoster infection,…).
  5. Placental abnormality (abruption placenta \& placenta previa)
  6. Cases with normal amniotic fluid study with ultrasonography.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Other
    Echogenic Amniotic Fluid

    estimation the nature of echogenic amniotic fluid.to overcome unnecessary intervention due to turbid amniotic fluid, assessing the neonatal outcome and estimation the gestational age at time of delivery in patients with echogenic amniotic fluid.

    Behavioral: Significance of Echogenic Amniotic Fluid on Perinatal Outcome

Interventions

  • BehavioralSignificance of Echogenic Amniotic Fluid on Perinatal Outcome

    To estimate the nature of echogenic amniotic fluid.and To overcome unnecessary intervention due to turbid amniotic fluid, assess neonatal outcome and estimate gestational age at time of delivery in patients with echogenic amniotic fluid.

06

What researchers measure

Primary outcomes

  1. Pregnant females with Echogenic Amniotic Fluid .

    Estimation the gestational age and neonatal status.

    Time frame: At the time of the Delivery

07

Study locations

1 site
  • Al-Azhar University hospitals
    Asyut, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05407571
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
Jun 7, 2022
Start date
Aug 1, 2022
Primary completion
Aug 1, 2023
Completion
Aug 30, 2023
Last update
Sep 8, 2023

Oversight

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

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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