Middle Cerebral To Umbilical Artery Doppler Ratio And Amn... | NCT02255903

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2022Estimated

Primary Completion Date

May 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Sep 30, 2014

First Posted Date

Oct 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2022

Last Update Posted Date

Feb 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated postdate pregnancy

Detailed Description

The Study Will be a case-control study that will be conducted at Banha University Hospital and AFHSR in Saudi Arabia after the approval of Institutional ethical committee. One hundred pregnant women will be recruited from antenatal clinic. Starting from November 2022. An informed consent will be obtained from the patients . The patients will be subdivided into two groups:

Group 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.

Group 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or more.

Inclusion criteria:

Singleton, viable fetus in the vertex presentation.
History of regular menstrual cycles.
Gestational age calculated from the first day of last menstryal period or by first-trimester or second-trimester (before 20 weeks) ultrasound examination.
No obstetric or medical complications of pregnancy apart from post-date pregnancy

All patients will be subjected to:

Detailed history: including, personal history, menstural history, obstetric history, present history and past history.
Physical examination: general, abdominal and pelvic examination.
Investigations: including, A- Ultrasound examintion for amniotic fluid index (AFI) measurement.

B- Doppler studies:

i - Middle cerebral artery pulsatility index (MCA -PI) and resistace index(MCA-RI).

ii - Umbilical artery pulsatility index (UA-PI) and resistance index (UA-RI). iii - Cerebro-Placental ratio (CPR).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1(Control Group):		ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks.	Other: ultrasound and Doppler examination
Group 2 (post date Group)		ultrasound and Doppler examination:will be done for 100 pregnant females with gestational age 41 weeks or more	Other: ultrasound and Doppler examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound and Doppler examination	Other	ultrasound and Doppler examination: Trans-abdominal ultrasound examination will be peformed to all patienst while women in a slightly tilted position with the head of the bed raised 30 degrees and with a small pillow under the right lion

Measure	Description	Time Frame
Adverse pregnancy outcome		at time of delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton, viable fetus in the vertex presentation
History of regular menstrual cycles
Gestational age calculated from the first day of last menstryal period or by first-trimester or second-trimester (before 20 weeks) ultrasound examination
No obstetric or medical complications of pregnancy apart from post-date pregnancy

Exclusion Criteria:

Patients unsure of their dates
Medical disorders with pregnancy as (hypertension, diabetes mellitus or Rh isoimmunization)
Prelabor rupture of membranes
Polyhydramnios
Women with multiple pregnancy
Congenital fetal anomalies
Antepartum hemorrhage
Previus cesarean section
Fetal malpresentation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Two hundred pregnant women will be recruited from outpatient clinic. Starting from February 2022. An informed consent will be obtained from the patients . The patients will be subdivided into two groups:

Group 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.

Group 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or more.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
khalid Ibrahim, MD	Contact	201281469651		dr.khalidkhader77@yahoo.com
KHALID IBRAHIM, MD	Contact	966596984055

Overall Officials

Name	Affiliation	Role
khalid ibrahim, MD	Armed Forces Hospitals, Southern Region, Saudi Arabia	Study Chair
KHALID IBRAHIM, MD	Armed Forces Hospitals, Southern Region, Saudi Arabia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AFHSR	Recruiting	Khamis Mushait	Afhsa	10018	Saudi Arabia

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation
D055585	Physical Phenomena