Placenta PreviaNCT05802251
Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study
An observational study of Placenta Previa, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Ultrasonographic parameters
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to Aug 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asymptomatic pregnant women diagnosed with placenta previa between 28 to 37 weeks' gestation.
Who may be able to join
- Asymptomatic women diagnosed with placenta previa according to RCOG (GTG No. 27a, 2018): placenta lies directly over the internal os for pregnancies more than 16 weeks' gestation on transabdominal or transvaginal scanning.
- Gestational age between 28 till 37 weeks' gestation (as delivery should be considered between 36 and 37 weeks of gestation for women presenting with uncomplicated placenta previa)
Who cannot join
- Multiple pregnancies.
- Threatened preterm labor or preterm rupture of membranes.
- History of bleeding in the current pregnancy.
- Polyhydraminos (AFI > 25 cm).
- History of cervical surgery (cone biopsy).
- Presence of cervical cerclage.
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- Maternal use of vaginla progesterone.
- History of maternal disease (hypertensive, DM, Cardiac).
- Fetal malformation or growth restriction
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain Shams University
Cairo, 11591
Ayman Abulnor, MD, 01223414990, aymanabulnour@gmail.com
About this study
The aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa.
Read the detailed description
The incidence of placenta previa is 3-5 per 1000 pregnancies worldwide and is still rising because of increased maternal age, parity, cesarean section rates, assisted reproductive technology, maternal smoking with the widespread use of transvaginal ultrasound. antepartum hemorrhage is an important cause of maternal and neonatal morbidity and mortality in pregnant women with placenta previa. However, the epidemiological characteristics are not completely understood. this study aims at evaluating the sonographic findings in asymptomatic women with placenta previa as cervical length, placenta thickness and distance from cervix to placental edge to recommend management for in-patients versus out-patient antenatal care and early planned hospital admission and delivery for women at high risk of antepartum hemorrhage and preterm cesarean section and hysterectomy for life threatening antepartum hemorrhage.
- Conditions
- Placenta Previa
- Being tested
- Ultrasonographic parameters
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic parametersDiagnostic test
cervical length. placental thickness. distance placental edge from internal os of the cervix
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal bleeding rate
number of attacks of antepartum hemorrhage
Measured: till delivery
Secondary outcomes (5)
Blood transfusion
number of PRBCs
Measured: till delivery 36 to 37 weeks
Emergency Cesarean section
severe antepartum hemorrhage requiring delivery
Measured: till delivery 36 to 37 weeks
Premature delivery
before the planned delivery date (before 37 weeks' gestation)
Measured: 37 week's gestation
Need for cesarean hysterectomy
cesarean hysterectomy due to bleeding or placenta accreta spectrum
Measured: during cesarean section
Postpartum hemorrhage
severity of attacks and required further management or blood transfusion
Measured: Within 2 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Jun 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Abdelrazek, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802251
- Sponsor's protocol ID
- MD 172 2022
- Status last verified
- Jul 2024
- First submitted
- 24 Mar 2023
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study
- ClinicalTrials.gov ID
- NCT05802251
- Acronym / sponsor ID
- MD 172 2022
- Conditions
- Placenta Previa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 6 Apr 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 aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa.
Detailed description
The incidence of placenta previa is 3-5 per 1000 pregnancies worldwide and is still rising because of increased maternal age, parity, cesarean section rates, assisted reproductive technology, maternal smoking with the widespread use of transvaginal ultrasound. antepartum hemorrhage is an important cause of maternal and neonatal morbidity and mortality in pregnant women with placenta previa. However, the epidemiological characteristics are not completely understood. this study aims at evaluating the sonographic findings in asymptomatic women with placenta previa as cervical length, placenta thickness and distance from cervix to placental edge to recommend management for in-patients versus out-patient antenatal care and early planned hospital admission and delivery for women at high risk of antepartum hemorrhage and preterm cesarean section and hysterectomy for life threatening antepartum hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asymptomatic pregnant women diagnosed with placenta previa between 28 to 37 weeks' gestation.
Key inclusion criteria (2 listed)
- Asymptomatic women diagnosed with placenta previa according to RCOG (GTG No. 27a, 2018): placenta lies directly over the internal os for pregnancies more than 16 weeks' gestation on transabdominal or transvaginal scanning.
- Gestational age between 28 till 37 weeks' gestation (as delivery should be considered between 36 and 37 weeks of gestation for women presenting with uncomplicated placenta previa)
Key exclusion criteria (9 listed)
- Multiple pregnancies.
- Threatened preterm labor or preterm rupture of membranes.
- History of bleeding in the current pregnancy.
- Polyhydraminos (AFI > 25 cm).
- History of cervical surgery (cone biopsy).
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 |
|---|---|---|
| Ultrasonographic parameterscervical length. placental thickness. distance placental edge from internal os of the cervix | Diagnostic test | – |
Primary outcome
maternal bleeding rate
Time frame: till delivery
number of attacks of antepartum hemorrhage
5 secondary outcomes
Blood transfusion
Time frame: till delivery 36 to 37 weeks
Emergency Cesarean section
Time frame: till delivery 36 to 37 weeks
Premature delivery
Time frame: 37 week's gestation
Need for cesarean hysterectomy
Time frame: during cesarean section
Postpartum hemorrhage
Time frame: Within 2 hours of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
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 Previa, run by Ain Shams 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 2 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 30 Jul 2024. 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 Maya Abdelrazek, MD (01222393983, dr_maya89@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal bleeding rate (time frame: till 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 30 Jul 2024.