Clinical trial NCT05645848: The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa
Official title: The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Previa
Vaginal Bleeding
Antepartum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with placenta previa

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy.
timeFrame: Through study completion, an average of 1 and half year
Secondary outcomes:
measure: Identification of the potential clinical and ultrasonographic predictors of antepartum hemorrhage in women with placenta previa at third trimester of pregnancy
timeFrame: through study completion, an average of 1 and half year
Other outcomes:
Locations:
Study officials:
affiliation: department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
name: Kamal M Zahran, professor
role: STUDY_CHAIR
affiliation: department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
name: Mohamed K Ali, doctor
role: STUDY_DIRECTOR
affiliation: department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
name: Mohamed M Abd-allah, doctor
role: STUDY_DIRECTOR
affiliation: department of obstetrics and gynecology, faculty of medicine, Assuit University, Egypt
name: Ismael O Ali, resident
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: Dashe JS. Toward consistent terminology of placental location. Semin Perinatol. 2013 Oct;37(5):375-9. doi: 10.1053/j.semperi.2013.06.017.
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.