Gestational DiabetesNCT05852639
Fetal CPR at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by GDM
An observational study of Gestational Diabetes, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational study is to evaluate fetal cerebroplacental ratio at term and its relation to adverse neonatal outcome in patients with gestational diabetes. The main question[s] it aims to answer are: To evaluate the efficacy (sensitivity \& specificity) of fetal cerebroplacental ratio at term in… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2022to Apr 2024
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The patients in our study will be recruited from Kasr al-Ainy hospital inpatient departments as follows: pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment.
Who may be able to join
- Maternal age: 18-40 years
- Diagnosed with gestational DM and are on insulin or metformin treatment.
- Single living pregnancy.
- Gestational age ≥ 37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).
Who cannot join
- Fetal anomalies.
- Maternal chronic diseases esp. renal disease, epilepsy or CNS lesion.
- Pregnancy induced medical disorders.
- IUGR (EFW below the 10th percentile for gestational age).
- Rupture of membranes or oligohydramnios (AFI < the fifth percentile).
Trial locations and contacts
1 site in 1 country.
Mahmoud Abd El Hameed contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr al-ainy hospital, Faculty of Medicine - Cairo University
Cairo, 11451
Moussa Abdelgawad, +202-23649281, pg@kasralainy.edu.eg
Mariam Gabr, +201227051013, mariam.a.gabr@gmail.com
About this study
Official title: Fetal Cerebroplacental Ratio at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by Gestational Diabetes
The goal of this observational study is to evaluate fetal cerebroplacental ratio at term and its relation to adverse neonatal outcome in patients with gestational diabetes. The main question[s] it aims to answer are:
- To evaluate the efficacy (sensitivity \& specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
- To evaluate the difference in fetal cerebroplacental ratio in patients treated by insulin \& those on metformin
- to evaluate the incidence of adverse neonatal outcome in patients treated by insulin \& those on metformin.
Participants will undergo ultrasound and doppler study at 37 weeks \& every two weeks thereafter till delivery. Neonatal assessment will be done after delivery to exclude adverse outcomes.
Read the detailed description
pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment. Informed consent, to share in the study, will be taken from all participants after describing the aim of the study and the potential hazards.
The patients enrolled in our study will be divided into two equal groups according to their treatment regimens:
(Group A): 130 patients who are on insulin treatment
(Group B): 130 patients who are on metformin
*All participants will be subjected to the following:
- Full history taking:
Including personal, menstrual, obstetric, present, past \& family history. B) Complete Physical Examination (general \& local).
- Investigations:
- Routine baseline investigations:
- Complete blood picture, Rh typing, liver \& kidney functions.
- HbA1C estimation.
- Surveillance of maternal diabetes: daily fasting and 2- hour postprandial capillary glucose measurement.
- Routine obstetric ultrasound will be done at term (at 37 weeks gestation): to confirm gestational age, assess fetal weight (EFW) and amniotic fluid index (AFI) and to exclude fetal anomalies.
- Doppler ultrasonography assessment:
Doppler study and Cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeks.To reduce inter-operator variability, a single experienced sonographer will perform all sonograms.
The mode of delivery and the gestational age at delivery will be noted
Early neonatal assessment:
- 1\&5 minutes APGAR score
- Neonatal blood glucose
- Neonatal cord blood PH
- The need for NICU admission
- Conditions
- Gestational Diabetes
- Being tested
- Ultrasound
- Keywords
- cerebroplacental ratio, adverse neonatal outcome
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Routine obstetric ultrasound will be done at term (at 37 weeks gestation): to confirm gestational age, assess fetal weight and amniotic fluid index and to exclude fetal anomalies.Doppler study and cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Insulin | patients on insulin treatment for gestational diabetes Receives: Device: Ultrasound | |
| Metformin | patients on metformin treatment for gestational diabetes Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
Measured: 17 months
Secondary outcomes (2)
To evaluate the difference in fetal cerebroplacental ratio in both groups
Measured: 17 months
To evaluate the incidence of adverse neonatal outcome in both groups
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start30 Nov 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Alaaeldin Aly Gabr, Cairo University
- Investigators
- Mariam Gabr, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852639
- Sponsor's protocol ID
- MD-329-2022
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Cerebroplacental Ratio at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by Gestational Diabetes
- ClinicalTrials.gov ID
- NCT05852639
- Acronym / sponsor ID
- MD-329-2022
- Conditions
- Gestational Diabetes
- Keywords
- cerebroplacental ratio, adverse neonatal outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 10 May 2023 (actual)
- 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 goal of this observational study is to evaluate fetal cerebroplacental ratio at term and its relation to adverse neonatal outcome in patients with gestational diabetes. The main question[s] it aims to answer are:
- To evaluate the efficacy (sensitivity \& specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
- To evaluate the difference in fetal cerebroplacental ratio in patients treated by insulin \& those on metformin
- to evaluate the incidence of adverse neonatal outcome in patients treated by insulin \& those on metformin.
Participants will undergo ultrasound and doppler study at 37 weeks \& every two weeks thereafter till delivery. Neonatal assessment will be done after delivery to exclude adverse outcomes.
Detailed description
pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment. Informed consent, to share in the study, will be taken from all participants after describing the aim of the study and the potential hazards.
The patients enrolled in our study will be divided into two equal groups according to their treatment regimens:
(Group A): 130 patients who are on insulin treatment
(Group B): 130 patients who are on metformin
*All participants will be subjected to the following:
- Full history taking:
Including personal, menstrual, obstetric, present, past \& family history. B) Complete Physical Examination (general \& local).
- Investigations:
- Routine baseline investigations:
- Complete blood picture, Rh typing, liver \& kidney functions.
- HbA1C estimation.
- Surveillance of maternal diabetes: daily fasting and 2- hour postprandial capillary glucose measurement.
- Routine obstetric ultrasound will be done at term (at 37 weeks gestation): to confirm gestational age, assess fetal weight (EFW) and amniotic fluid index (AFI) and to exclude fetal anomalies.
- Doppler ultrasonography assessment:
Doppler study and Cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeks.To reduce inter-operator variability, a single experienced sonographer will perform all sonograms.
The mode of delivery and the gestational age at delivery will be noted
Early neonatal assessment:
- 1\&5 minutes APGAR score
- Neonatal blood glucose
- Neonatal cord blood PH
- The need for NICU admission
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | – | Device: Ultrasoundpatients on insulin treatment for gestational diabetes |
| Metformin | – | Device: Ultrasoundpatients on metformin treatment for gestational diabetes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients in our study will be recruited from Kasr al-Ainy hospital inpatient departments as follows: pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment.
Key inclusion criteria (4 listed)
- Maternal age: 18-40 years
- Diagnosed with gestational DM and are on insulin or metformin treatment.
- Single living pregnancy.
- Gestational age ≥ 37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).
Key exclusion criteria (5 listed)
- Fetal anomalies.
- Maternal chronic diseases esp. renal disease, epilepsy or CNS lesion.
- Pregnancy induced medical disorders.
- IUGR (EFW below the 10th percentile for gestational age).
- Rupture of membranes or oligohydramnios (AFI < the fifth percentile).
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 |
|---|---|---|
| UltrasoundRoutine obstetric ultrasound will be done at term (at 37 weeks gestation): to confirm gestational age, assess fetal weight and amniotic fluid index and to exclude fetal anomalies.Doppler study and cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeks | Device | Insulin, Metformin |
Primary outcome
To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
Time frame: 17 months
2 secondary outcomes
To evaluate the difference in fetal cerebroplacental ratio in both groups
Time frame: 17 months
To evaluate the incidence of adverse neonatal outcome in both groups
Time frame: 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud Abd El Hameed contact
Mariam Gabr principal investigator
Cairo University
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 Gestational Diabetes, run by Cairo University at 1 site in Egypt.
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 5 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 10 May 2023. 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 Egypt. 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 Mariam Gabr (+201227051013, mariam.a.gabr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes (time frame: 17 months). 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 10 May 2023.