Assessment of Mean Fetal Kidney Length as a Reliable Parameter for Accurate Estimation of Gestational Age in Late 2nd and 3rd Trimesters

NCT ID: NCT07188324

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-21

Study Completion Date

2026-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Accurate GA estimation is necessary when early termination of pregnancy is necessary as soon as the fetus becomes mature e.g. cases of pre-eclampsia, chronic renal disease, severe intrauterine growth retardation (IUGR), diabetes and placenta praevia centralis. Accurate GA estimation is also necessary where certain tests need to be performed for example amniotic fluid and serum assays, chorionic villus sampling and to plan fetal therapies. (Gupta DP et al., 2013)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There are number of parameters used to calculate gestational age, but the most commonly used by all sonologists is a composite gestational age obtained by biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), and femur length (FL) in the second and third trimesters (Jae SS et al., 2007). Even these may not provide gestational age with great accuracy owing to discrepancies in late-trimester scans and intrauterine growth restriction (IUGR).

Fetal kidney shows steady growth of 1.1 mm/ gestational week throughout the pregnancy unaffected by any underlying growth abnormalities (Ahmadi et al., 2015). By prenatal ultrasound, identification of either one or both kidneys is possible in 90% of cases in the 17th week of gestation and in 95% of cases after the 20th week. Although kidney size, as for all fetal organs, is affected by growth variations, these appear to predominantly affect only anterior- posterior and transverse diameters (width of kidney) (Callen A., 2008). However, its length shows no significant change with any underlying medical condition (Kansaria and Parulekar, 2010).Fetal kidney length (FKL) has recently been found to have a strong correlation with gestational age. According to the investigations, the fetal kidney length may be utilized to estimate gestational age when dates are ambiguous or when women seek ultrasound fetal biometry dating during the third trimester itself (Kansaria J et al., 2009). Fetal kidney length (FKL), according to a number of studies, closely corresponds with gestational age in the third trimester. Although ultrasound textbooks frequently include tables of various sizes, the fetal kidney has not received much research as a biometric criterion for estimating gestational age(Goyal L et al., 2016).

This study aims to assess the uses of the mean fetal kidney length as reliable parameter for accurate determination of gestational age in late 2nd and/or 3rd trimesters (24 weeks - 40 weeks) in cases who are not sure about their last menstrual period and need proper management of any health problem such as preeclampsia, diabetes or fetal growth abnormality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fetal Conditions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All healthy women with viable normal singleton pregnancies in their late second and third trimesters (24 weeks - 40 weeks) calculated from their last menstrual period.
* Women who will sure of the dates of their last menstrual period (1st day) and/or those with first obstetrics dating using crown rump length (CRL). 3- Women with regular menstrual cycle in last three months before their last menstrual period.

Exclusion Criteria

* Women with high-risk pregnancies such as preeclampsia, diabetes, hypertension, polyhydramnios.

❖ Maternal:
* Multiple pregnancies.
* Gross maternal obesity.

❖ Fetal:
* Fetus with congenital anomalies especially renal anomalies.
* Fetuses with abnormal renal morphology (a genesis, hypoplasia, cysts, nephromegaly, polycystic kidney, hydronephrosis, etc.…
* Fetuses with renal pelvic dilatation of 5 mm or greater, obscured adrenal and renal border.
* Fetus with growth abnormalities (intrauterine growth retardation or macrosomia).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shaimaa Mostafa Mohammed Refaay El shemy

Assistant professor of Obstetrics and Gynecology faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine, Cairo University

Giza, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shaimaa El Shemy, MD

Role: CONTACT

01220632263 ext. 02

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shaimaa El Shemy, MD

Role: primary

01220632263 ext. 02

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Fetal kidney length by 2D us

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Accuracy of Rail Sign at Detection of PAS
NCT07159997 NOT_YET_RECRUITING NA
WHO Fetal Growth Charts
NCT03755024 UNKNOWN