Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City

January 30, 2022 updated by: khalid abd aziz mohamed, Benha University

Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Faisal Military Central City

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

Study Overview

Status

Recruiting

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:

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

All patients will be subjected to:

  1. Detailed history: including, personal history, menstural history, obstetric history, present history and past history.
  2. Physical examination: general, abdominal and pelvic examination.
  3. 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).

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: KHALID IBRAHIM, MD
  • Phone Number: 966596984055

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 48 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients unsure of their dates
  2. Medical disorders with pregnancy as (hypertension, diabetes mellitus or Rh isoimmunization)
  3. Prelabor rupture of membranes
  4. Polyhydramnios
  5. Women with multiple pregnancy
  6. Congenital fetal anomalies
  7. Antepartum hemorrhage
  8. Previus cesarean section
  9. Fetal malpresentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse pregnancy outcome
Time Frame: at time of delivery
at time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: khalid ibrahim, MD, Armed Forces Hospitals, Southern Region, Saudi Arabia
  • Study Director: KHALID IBRAHIM, MD, Armed Forces Hospitals, Southern Region, Saudi Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (ESTIMATE)

October 3, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 30, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • khalid-mohamed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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