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

NCT ID: NCT02255903

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-08-31

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:

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).

Conditions

Pregnancy, Prolonged

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1(Control Group):

ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks.

ultrasound and Doppler examination

Intervention Type: 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

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

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

khalid abd aziz mohamed

lecturer and consultant of oblgyne

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

khalid ibrahim, MD

Role: STUDY_CHAIR

Armed Forces Hospitals, Southern Region, Saudi Arabia

KHALID IBRAHIM, MD

Role: STUDY_DIRECTOR

Armed Forces Hospitals, Southern Region, Saudi Arabia

Locations

AFHSR

Khamis Mushait, Afhsa, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

khalid Ibrahim, MD

Role: CONTACT

dr.khalidkhader77@yahoo.com

201281469651

KHALID IBRAHIM, MD

Role: CONTACT

966596984055

Facility Contacts

khalid ibrahum, MD

Role: primary

dr.khalidkhader77@yahoo.com

201281469651

Other Identifiers

khalid-mohamed

Identifier Type: -

Identifier Source: org_study_id