Placenta PreviaNCT03431116
Low Implanted Second Trimester Placenta and Placenta Previa
An observational study of Placenta Previa, run by Assiut University at 1 site in Egypt.
Trial summary
Placenta Previa is defined as a placenta implanted in the lower segment of the uterus, presenting ahead of the leading pole of the fetus (over or near the internal os). The prevalence of placenta previa has been estimated to be approximately 0.5% of all pregnancies, and this increase correlates to the elevated… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2016to 30 Apr 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: low implanted placenta women
Who may be able to join
- Pregnant women between 18-24 weeks.
- Diagnosed to have low implanted placenta by ultrasound
Who cannot join
- Patient refused to follow-up in our setting.
- Patient refused to perform Trans-vaginal ultrasound in the second trimester of gestation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prediction of Risk Factors of Progression of Low Implanted Placenta at 18- 24 Weeks to Placenta Previa at Term
Placenta Previa is defined as a placenta implanted in the lower segment of the uterus, presenting ahead of the leading pole of the fetus (over or near the internal os). The prevalence of placenta previa has been estimated to be approximately 0.5% of all pregnancies, and this increase correlates to the elevated cesarean section rate . In Egypt, the prevalence of placenta previa is around 1.3% in Sohag Governorate and 1.5% in Aswan region according to.
Although various studies have tried to address risk factors associated with Placenta Previa development, the etiology of placenta previa still remains obscure. Several risk actors have been identified as strong contributors to placenta previa development. It is also a significant contributor to severe postpartum hemorrhage.Risk factors include; history of previous cesarean section, advanced maternal age, history of previous abortions, high parity and substance abuse during pregnancy (cigarette smoking), placental size (multiple pregnancy), endometrial damage (previous dilatation and curettage), uterine scars and pathology (previous myomectomy or endometritis), placental pathology (marginal cord insertions and succenturiate lobes), previous placental Previa, and curiously.
- Conditions
- Placenta Previa
- Being tested
- ultrasound
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundRadiation
to detect the placental site
| Study group | Role | What they receive |
|---|---|---|
| Low implanted placenta group | Not described Receives: Radiation: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance between lower edge of the placenta and internal os by ultrasound (millimeter)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Oct 2016
- Primary completion30 Mar 2017
- Study completion30 Apr 2017
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 Assiut 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431116
- Sponsor's protocol ID
- PPLIP
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- 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 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Risk Factors of Progression of Low Implanted Placenta at 18- 24 Weeks to Placenta Previa at Term
- ClinicalTrials.gov ID
- NCT03431116
- Acronym / sponsor ID
- PPLIP
- Conditions
- Placenta Previa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 13 Feb 2018 (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.
Placenta Previa is defined as a placenta implanted in the lower segment of the uterus, presenting ahead of the leading pole of the fetus (over or near the internal os). The prevalence of placenta previa has been estimated to be approximately 0.5% of all pregnancies, and this increase correlates to the elevated cesarean section rate . In Egypt, the prevalence of placenta previa is around 1.3% in Sohag Governorate and 1.5% in Aswan region according to.
Although various studies have tried to address risk factors associated with Placenta Previa development, the etiology of placenta previa still remains obscure. Several risk actors have been identified as strong contributors to placenta previa development. It is also a significant contributor to severe postpartum hemorrhage.Risk factors include; history of previous cesarean section, advanced maternal age, history of previous abortions, high parity and substance abuse during pregnancy (cigarette smoking), placental size (multiple pregnancy), endometrial damage (previous dilatation and curettage), uterine scars and pathology (previous myomectomy or endometritis), placental pathology (marginal cord insertions and succenturiate lobes), previous placental Previa, and curiously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low implanted placenta group | – | Radiation: ultrasound |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- low implanted placenta women
Key inclusion criteria (2 listed)
- Pregnant women between 18-24 weeks.
- Diagnosed to have low implanted placenta by ultrasound
Key exclusion criteria (2 listed)
- Patient refused to follow-up in our setting.
- Patient refused to perform Trans-vaginal ultrasound in the second trimester of gestation.
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 |
|---|---|---|
| ultrasoundto detect the placental site | Radiation | Low implanted placenta group |
Primary outcome
The distance between lower edge of the placenta and internal os by ultrasound (millimeter)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- 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.
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 Previa, run by Assiut 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 2 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: finished, as of the sponsor's last update on 13 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The distance between lower edge of the placenta and internal os by ultrasound (millimeter) (time frame: 12 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 13 Feb 2018; AzTrials last refreshed its copy on 28 Oct 2026.