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

Sponsor

Benha University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02255903

Collaborator

(none)

200

Enrollment

Location

17.9

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, Prolonged	Other: ultrasound and Doppler examination

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group 1(Control Group): ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks.	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
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 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

Arm

Intervention/Treatment

Group 1(Control Group):

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

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

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

Outcome Measures

Primary Outcome Measures

Adverse pregnancy outcome [at time of delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AFHSR	Khamis Mushait	Afhsa	Saudi Arabia	10018

Sponsors and Collaborators

Benha University

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

khalid abd aziz mohamed, lecturer and consultant of oblgyne, Benha University

ClinicalTrials.gov Identifier:

NCT02255903

Other Study ID Numbers:

khalid-mohamed

First Posted:

Oct 3, 2014

Last Update Posted:

Feb 14, 2022

Last Verified:

Jan 1, 2022

Additional relevant MeSH terms:

Pregnancy, Prolonged

Study Results

No Results Posted as of Feb 14, 2022