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

Pregnancy, Prolonged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02255903
• Other study ID #: khalid-mohamed
• Status: Recruiting
• Start date: February 2022
• Est. completion date: August 2023

Study information

• Verified date: January 2022
• Source: Benha University
• Contact: khalid Ibrahim, MD
• Phone: 201281469651
• Email: dr.khalidkhader77[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, Prolonged

Intervention

Other:
• ultrasound and Doppler examination
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

Locations

Country	Name	City	State
Saudi Arabia	AFHSR	Khamis Mushait	Afhsa

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse pregnancy outcome		at time of delivery