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

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ClinicalTrials.gov Identifier: NCT02255903
Recruitment Status : Recruiting
First Posted : October 3, 2014
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

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
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 AFHSA in Saudi Arabia after the approval of Institutional ethical committee. One hundred pregnant women will be recruited from antenatal clinic. Starting from November 2013. 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).

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Study Type : Observational
Estimated 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 Khalid Military Central City
Actual Study Start Date : February 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Group/Cohort 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




Primary Outcome Measures :
  1. Adverse pregnancy outcome [ Time Frame: at time of delivery ]


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Ages Eligible for Study:   19 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Two hundred pregnant women will be recruited from outpatient clinic. Starting from February 2016. 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255903


Contacts
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Contact: khalid Ibrahim, MD 201281469651 dr.khalidkhader77@yahoo.com
Contact: ibrahim zweel, MD 966596984055 dribrahimzweel@gmail.com

Locations
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Saudi Arabia
NAAFH Recruiting
Khamis Mushait, Afhsa, Saudi Arabia, 10018
Contact: khalid ibrahum, MD    201281469651    dr.khalidkhader77@yahoo.com   
Contact: ibrahim zweel, MD       dribrahimzweel@gmail.com   
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: ibrahim zweel Department of Obstetrics and Gynecology,AFHSA
Study Chair: Khaled IBRAHIM consultant of ob/gyne at AFHSA
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Responsible Party: khalid abd aziz mohamed, lecturer and consultant of oblgyne, Benha University
ClinicalTrials.gov Identifier: NCT02255903    
Other Study ID Numbers: khalid-mazen
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Pregnancy, Prolonged
Pregnancy Complications