Clinical trial NCT02255903: Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City
Official title: Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Faisal Military Central City
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy, Prolonged
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: Adverse pregnancy outcome
timeFrame: at time of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: AFHSR
state: Afhsa
Study officials:
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: khalid ibrahim, MD
role: STUDY_CHAIR
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: KHALID IBRAHIM, MD
role: STUDY_DIRECTOR
References: