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

NCT05645848 | Unknown

• 1 other identifier: placenta previa bleeding rate
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Placenta Previa; Vaginal Bleeding; Antepartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  through study completion, an average of 1 and half year

Interventions

Ultrasonography DEVICE

Abdominal ultrasound in pregnant women with placenta previa

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women with placenta previa

You may qualify if:

• Pregnant women ≥ 28 weeks.
• Diagnosed to have placenta previa by ultrasound

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 15902137 BACKGROUND

• Shaamash 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.

  PMID: 31670998 BACKGROUND

• Shazly 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.

  PMID: 22681562 BACKGROUND

• Nagase 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.

  PMID: 33407322 BACKGROUND

• Dashe JS. Toward consistent terminology of placental location. Semin Perinatol. 2013 Oct;37(5):375-9. doi: 10.1053/j.semperi.2013.06.017.

  PMID: 24176163 BACKGROUND

• Love 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.

  PMID: 15474239 BACKGROUND

MeSH Terms

Conditions

Placenta Previa; Uterine Hemorrhage

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kamal M Zahran, professor

  department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Ismael O Ali, resident

  department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismael O Ali, resident

CONTACT

+201033039300; Ismael_alyy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 12, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 12, 2022

Record last verified: 2022-12