Placenta AccretaNCT04082507
Maternal Serum Alpha-fetoprotein Level May Predict the Presence of Morbid Adherent Placenta
An observational study of Placenta Accreta, run by rasha medhat abdul-hady at 1 site in Egypt.
Trial summary
The aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Serum alpha-fetoproteine
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 30 Aug 2019
- 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: 150 pregnant women from 28wk to full term who are attending outpatient clinic and emergency room ain shams university maternal hospital
Who may be able to join
- pregnant women with history of scarred uterus
- plcenta previa covering the scar of previous caesarean section as diagnosed by 2DU/S
- Gestational age from 28wks to full term
Who cannot join
- pregnant women with fetus with congenital anomalies
- pregnant women with ovarian swelling
- pregnant women with medical disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alpha-fetoprotein as a Biochemical Marker in Prediction of Placenta Acreta Increta Percreta
The aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta.
Read the detailed description
in pregnant women withe previous cesarean section, placenta previa and ultrasonographic finding of an abnormally adherent placenta dose maternal serum alpha-fetoprotein predict prenataly the presence of morbid adherent placenta accurately?
- Conditions
- Placenta Accreta
- Being tested
- Serum alpha-fetoproteine
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum alpha-fetoproteineDiagnostic test
Also called 2D Ultrasound, 3D power doppler with MS US
Midtrimesteric serum alpha-fetoprotein mesurment with 2D US and 3D power Doppler with MS US scan .
| Study group | Role | What they receive |
|---|---|---|
| Non_adherent plcenta | placenta separated within 15 minutes after delivery of fetus | |
| Adherent placenta | placenta dosenot separated within 15 minutes after delivery of fetus Receives: Diagnostic Test: Serum alpha-fetoproteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal serum alpha-fetoprotein
ng/ml or MOM(Multiple of the median)
Measured: From 28weeks to 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Jan 2017
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- rasha medhat abdul-hady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, rasha medhat abdul-hady, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082507
- Sponsor's protocol ID
- AFP_AP
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-fetoprotein as a Biochemical Marker in Prediction of Placenta Acreta Increta Percreta
- ClinicalTrials.gov ID
- NCT04082507
- Acronym / sponsor ID
- AFP_AP
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- rasha medhat abdul-hadyUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 9 Sep 2019 (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 aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta.
Detailed description
in pregnant women withe previous cesarean section, placenta previa and ultrasonographic finding of an abnormally adherent placenta dose maternal serum alpha-fetoprotein predict prenataly the presence of morbid adherent placenta accurately?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non_adherent plcenta | – | –placenta separated within 15 minutes after delivery of fetus |
| Adherent placenta | – | Diagnostic Test: Serum alpha-fetoproteineplacenta dosenot separated within 15 minutes after delivery of fetus |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 150 pregnant women from 28wk to full term who are attending outpatient clinic and emergency room ain shams university maternal hospital
Key inclusion criteria (3 listed)
- pregnant women with history of scarred uterus
Key exclusion criteria (3 listed)
- pregnant women with fetus with congenital anomalies
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 |
|---|---|---|
| Serum alpha-fetoproteineAlso: 2D Ultrasound, 3D power doppler with MS USMidtrimesteric serum alpha-fetoprotein mesurment with 2D US and 3D power Doppler with MS US scan . | Diagnostic test | Adherent placenta |
Primary outcome
Maternal serum alpha-fetoprotein
Time frame: From 28weeks to 37 weeks
ng/ml or MOM(Multiple of the median)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Placenta Accreta, run by rasha medhat abdul-hady 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 3 inclusion and 3 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 9 Sep 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal serum alpha-fetoprotein (time frame: From 28weeks to 37 weeks). 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 9 Sep 2019.