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

Placenta Previa Clinical Trial

Official title:

The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa: A Cross-sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05645848
• Other study ID #: placenta previa bleeding rate
• Status: Not yet recruiting
• Start date: December 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2022
• Source: Assiut University
• Contact: Ismael O Ali, resident
• Phone: +201033039300
• Email: Ismael_alyy[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 . 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Antepartum Hemorrhage
• Hemorrhage
• Placenta Previa
• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

Device:
• Ultrasonography
Abdominal ultrasound in pregnant women with placenta previa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	through study completion, an average of 1 and half year