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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05407571
Other study ID # Hanaa Ibrahim
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date August 30, 2023

Study information

Verified date September 2023
Source Egymedicalpedia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date August 30, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility 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: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Significance 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.

Locations

Country Name City State
Egypt Al-Azhar University hospitals Assiut

Sponsors (1)

Lead Sponsor Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnant females with Echogenic Amniotic Fluid . Estimation the gestational age and neonatal status. At the time of the Delivery
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05474326 - Effect of Intermittent Pneumatic Compression Device of Lower Limbs in Oligohydramnios N/A
Terminated NCT03857659 - Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care N/A