Pregnancy, ProlongedNCT02255903
Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City
An observational study of Pregnancy, Prolonged, run by Benha University at 1 site in Saudi Arabia.
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 Read more about this study
- Who is it for?
- Ages 19 to 48 years, women only
- Conditions the study is for
- Pregnancy, Prolonged
- What is being tested?
- ultrasound and Doppler examination
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 48 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Antepartum hemorrhage
- Previus cesarean section
- Fetal malpresentation
Trial locations and contacts
1 site in 1 country.
KHALID IBRAHIM, MD contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
AFHSR
Khamis Mushait, Afhsa, 10018
khalid ibrahum, MD, 201281469651, dr.khalidkhader77@yahoo.com
About this study
Official title: Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Faisal Military Central City
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
Read the 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).
- Conditions
- Pregnancy, Prolonged
- Being tested
- ultrasound and Doppler examination
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound and Doppler examinationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1(Control Group): | ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks. Receives: Other: ultrasound and Doppler examination | |
| Group 2 (post date Group) | ultrasound and Doppler examination:will be done for 100 pregnant females with gestational age 41 weeks or more Receives: Other: ultrasound and Doppler examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse pregnancy outcome
Measured: at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startFeb 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, ProlongedStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid abd aziz mohamed, Benha University
- Investigators
- khalid ibrahim, MD, Study chair, Armed Forces Hospitals, Southern Region, Saudi ArabiaKHALID IBRAHIM, MD, Study director, Armed Forces Hospitals, Southern Region, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255903
- Sponsor's protocol ID
- khalid-mohamed
- Status last verified
- Jan 2022
- First submitted
- 26 Sep 2014
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Faisal Military Central City
- ClinicalTrials.gov ID
- NCT02255903
- Acronym / sponsor ID
- khalid-mohamed
- Conditions
- Pregnancy, Prolonged
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(Control Group): | – | Other: ultrasound and Doppler examinationultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks. |
| Group 2 (post date Group) | – | Other: ultrasound and Doppler examinationultrasound and Doppler examination:will be done for 100 pregnant females with gestational age 41 weeks or more |
Who may qualify
- Ages
- 19 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound and Doppler examinationultrasound 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 | Other | Group 1(Control Group):, Group 2 (post date Group) |
Primary outcome
Adverse pregnancy outcome
Time frame: at time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KHALID IBRAHIM, MD contact
khalid ibrahim, MD study chair
Armed Forces Hospitals, Southern Region, Saudi Arabia
KHALID IBRAHIM, MD study director
Armed Forces Hospitals, Southern Region, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Prolonged, run by Benha University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact khalid Ibrahim, MD (201281469651, dr.khalidkhader77@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse pregnancy outcome (time frame: at time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.