Placenta PreviaNCT05645848
The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa
An observational study of Placenta Previa and Vaginal Bleeding, run by Assiut University.
Trial summary
Placenta previa is usually diagnosed when the placenta implanted in the lower uterine segment, thus partially or totally overlying the internal os . It occurs with an incidence of 0.3-0.5%. It is associated mainly with prior caesarean delivery . Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Previa, Vaginal Bleeding, Antepartum Hemorrhage
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Jan 2025
- 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: pregnant women with placenta previa
Who may be able to join
- Pregnant women ≥ 28 weeks.
- Diagnosed to have placenta previa by ultrasound
Who cannot join
- Women with complicated pregnancies (e.g. preeclampsia, diabetes mellitus and cardiac, renal, antiphospholipid syndrome).
- Women with premature rupture of membrane.
- Women who will refuse to participate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa: A Cross-sectional Study
Placenta previa is usually diagnosed when the placenta implanted in the lower uterine segment, thus partially or totally overlying the internal os . It occurs with an incidence of 0.3-0.5%. It is associated mainly with prior caesarean delivery . The condition is frequently complicated by invasion of placental villi beyond the decidua basalis causing placenta accreta . Placenta previa is a major cause of massive haemorrhage during pregnancy and after delivery . The antepartum bleeding from placenta previa- can be life-threatening, thus, the prediction of this bleeding is of great importance . It is important to distinguish between women at high and low risk for antepartum haemorrhage with placenta previa especially at late pregnancy . However, the potential risk factors for antepartum haemorrhage in women with placenta previa have not been thoroughly examined.
- Conditions
- Placenta Previa, Vaginal Bleeding, Antepartum Hemorrhage
- Being tested
- Ultrasonography
- Medical subject headings
- Placenta Previa, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Abdominal ultrasound in pregnant women with placenta previa
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy.
The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy.
Measured: Through study completion, an average of 1 and half year
Secondary outcomes (1)
Identification of the potential clinical and ultrasonographic predictors of antepartum hemorrhage in women with placenta previa at third trimester of pregnancy
The result that the investigators will get from the study will help identify predictors of antepartum hemorrhage in pregnant women with placenta previa and hence preventing it, antepartum hemorrhage is a major life threatening complication of the disease wether to the baby or the mother
Measured: through study completion, an average of 1 and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Omar Mohammed Ali, Assiut University
- Investigators
- Kamal M Zahran, professor, Study chair, department of obstetrics and gynecology, faculty of medicine, Assuit University, EgyptMohamed K Ali, doctor, Study director, department of obstetrics and gynecology, faculty of medicine, Assuit University, EgyptMohamed M Abd-allah, doctor, Study director, department of obstetrics and gynecology, faculty of medicine, Assuit University, EgyptIsmael O Ali, resident, Principal investigator, department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645848
- Sponsor's protocol ID
- placenta previa bleeding rate
- Status last verified
- Dec 2022
- First submitted
- 4 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu S, Kocherginsky M, Hibbard JU. Abnormal placentation: twenty-year analysis. Am J Obstet Gynecol. 2005 May;192(5):1458-61. doi: 10.1016/j.ajog.2004.12.074.
PubMed 15902137Shaamash AH, Ali MK, Attyia KM. Intramuscular 17alpha-hydroxyprogesterone caproate to decrease preterm delivery in women with placenta praevia: a randomised controlled trial. J Obstet Gynaecol. 2020 Jul;40(5):633-638. doi: 10.1080/01443615.2019.1645099. Epub 2019 Oct 31.
PubMed 31670998Shazly SA, Badee AY, Ali MK. The use of multiple 8 compression suturing as a novel procedure to preserve fertility in patients with placenta accreta: case series. Aust N Z J Obstet Gynaecol. 2012 Aug;52(4):395-9. doi: 10.1111/j.1479-828X.2012.01449.x. Epub 2012 Jun 9.
PubMed 22681562Nagase Y, Matsuzaki S, Endo M, Hara T, Okada A, Mimura K, Hiramatsu K, Kakigano A, Nakatsuka E, Miyake T, Takiuchi T, Ueda Y, Tomimatsu T, Kimura T. Placenta previa with posterior extrauterine adhesion: clinical features and management practice. BMC Surg. 2021 Jan 6;21(1):10. doi: 10.1186/s12893-020-01027-9.
PubMed 33407322Dashe JS. Toward consistent terminology of placental location. Semin Perinatol. 2013 Oct;37(5):375-9. doi: 10.1053/j.semperi.2013.06.017.
PubMed 24176163Love CD, Fernando KJ, Sargent L, Hughes RG. Major placenta praevia should not preclude out-patient management. Eur J Obstet Gynecol Reprod Biol. 2004 Nov 10;117(1):24-9. doi: 10.1016/j.ejogrb.2003.10.039.
PubMed 15474239
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05645848
- Acronym / sponsor ID
- placenta previa bleeding rate
- Conditions
- Placenta Previa, Vaginal Bleeding, Antepartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 12 Dec 2022 (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 usually diagnosed when the placenta implanted in the lower uterine segment, thus partially or totally overlying the internal os . It occurs with an incidence of 0.3-0.5%. It is associated mainly with prior caesarean delivery . The condition is frequently complicated by invasion of placental villi beyond the decidua basalis causing placenta accreta . Placenta previa is a major cause of massive haemorrhage during pregnancy and after delivery . The antepartum bleeding from placenta previa- can be life-threatening, thus, the prediction of this bleeding is of great importance . It is important to distinguish between women at high and low risk for antepartum haemorrhage with placenta previa especially at late pregnancy . However, the potential risk factors for antepartum haemorrhage in women with placenta previa have not been thoroughly examined.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women with placenta previa
Key inclusion criteria (2 listed)
- Pregnant women ≥ 28 weeks.
- Diagnosed to have placenta previa by ultrasound
Key exclusion criteria (3 listed)
- Women with complicated pregnancies (e.g. preeclampsia, diabetes mellitus and cardiac, renal, antiphospholipid syndrome).
- Women with premature rupture of membrane.
- Women who will refuse to participate.
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 |
|---|---|---|
| UltrasonographyAbdominal ultrasound in pregnant women with placenta previa | Device | – |
Primary outcome
The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy.
Time frame: Through study completion, an average of 1 and half year
The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy.
1 secondary outcome
Identification of the potential clinical and ultrasonographic predictors of antepartum hemorrhage in women with placenta previa at third trimester of pregnancy
Time frame: through study completion, an average of 1 and half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 15902137Wu S, Kocherginsky M, Hibbard JU. Abnormal placentation: twenty-year analysis. Am J Obstet Gynecol. 2005 May;192(5):1458-61. doi: 10.1016/j.ajog.2004.12.074.
- Background: PubMed 31670998Shaamash AH, Ali MK, Attyia KM. Intramuscular 17alpha-hydroxyprogesterone caproate to decrease preterm delivery in women with placenta praevia: a randomised controlled trial. J Obstet Gynaecol. 2020 Jul;40(5):633-638. doi: 10.1080/01443615.2019.1645099. Epub 2019 Oct 31.
- Background: PubMed 22681562Shazly SA, Badee AY, Ali MK. The use of multiple 8 compression suturing as a novel procedure to preserve fertility in patients with placenta accreta: case series. Aust N Z J Obstet Gynaecol. 2012 Aug;52(4):395-9. doi: 10.1111/j.1479-828X.2012.01449.x. Epub 2012 Jun 9.
- Background: PubMed 33407322Nagase Y, Matsuzaki S, Endo M, Hara T, Okada A, Mimura K, Hiramatsu K, Kakigano A, Nakatsuka E, Miyake T, Takiuchi T, Ueda Y, Tomimatsu T, Kimura T. Placenta previa with posterior extrauterine adhesion: clinical features and management practice. BMC Surg. 2021 Jan 6;21(1):10. doi: 10.1186/s12893-020-01027-9.
- Background: PubMed 24176163Dashe JS. Toward consistent terminology of placental location. Semin Perinatol. 2013 Oct;37(5):375-9. doi: 10.1053/j.semperi.2013.06.017.
- Background: PubMed 15474239Love CD, Fernando KJ, Sargent L, Hughes RG. Major placenta praevia should not preclude out-patient management. Eur J Obstet Gynecol Reprod Biol. 2004 Nov 10;117(1):24-9. doi: 10.1016/j.ejogrb.2003.10.039.
Related trials for Placenta Previa
Not yet recruiting
ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Placenta Previa
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
RecruitingObservational study
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
Antenatal Care, Maternal Health
Recruiting
Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia
Placenta Previa
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.
Kamal M Zahran, professor study chair
department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
Mohamed K Ali, doctor study director
department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
Mohamed M Abd-allah, doctor study director
department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa and Vaginal Bleeding, run by Assiut University.
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 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Ismael O Ali, resident (+201033039300, Ismael_alyy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy. (time frame: Through study completion, an average of 1 and half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645848, which also lists 6 linked publications.
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 12 Dec 2022.