The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05645848
Collaborator
(none)
250
25

Study Details

Study Description

Brief 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 . 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasonography

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa: A Cross-sectional Study
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

  1. The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy. [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.

Secondary Outcome Measures

  1. Identification of the potential clinical and ultrasonographic predictors of antepartum hemorrhage in women with placenta previa at third trimester of pregnancy [through study completion, an average of 1 and half year]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pregnant women ≥ 28 weeks.

  • Diagnosed to have placenta previa by ultrasound

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Kamal M Zahran, professor, department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
  • Study Director: Mohamed K Ali, doctor, department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
  • Study Director: Mohamed M Abd-allah, doctor, department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
  • Principal Investigator: Ismael O Ali, resident, department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ismail Omar Mohammed Ali, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05645848
Other Study ID Numbers:
  • placenta previa bleeding rate
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 12, 2022