NCT05407571

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

May 29, 2022

Last Update Submit

September 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pregnant females with Echogenic Amniotic Fluid .

    Estimation the gestational age and neonatal status.

    At the time of the Delivery

Study Arms (1)

Echogenic Amniotic Fluid

OTHER

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

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.

Echogenic Amniotic Fluid

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Asyut, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 7, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 30, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations