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

December 8, 2022 updated by: Ismail Omar Mohammed Ali, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women with placenta previa

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 and half year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
through study completion, an average of 1 and half year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Estimate)

December 12, 2022

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • placenta previa bleeding rate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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