Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05802251
Collaborator
(none)
68
1
24
2.8

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasonographic parameters

Detailed Description

The incidence of placenta previa is 3-5 per 1000 pregnancies worldwide and is still rising because of increased maternal age, parity, cesarean section rates, assisted reproductive technology, maternal smoking with the widespread use of transvaginal ultrasound. antepartum hemorrhage is an important cause of maternal and neonatal morbidity and mortality in pregnant women with placenta previa. However, the epidemiological characteristics are not completely understood. this study aims at evaluating the sonographic findings in asymptomatic women with placenta previa as cervical length, placenta thickness and distance from cervix to placental edge to recommend management for in-patients versus out-patient antenatal care and early planned hospital admission and delivery for women at high risk of antepartum hemorrhage and preterm cesarean section and hysterectomy for life threatening antepartum hemorrhage.

Study Design

Study Type:
Observational
Anticipated Enrollment :
68 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. maternal bleeding rate [till delivery]

    number of attacks of antepartum hemorrhage

Secondary Outcome Measures

  1. Blood transfusion [till delivery 36 to 37 weeks]

    number of PRBCs

  2. Emergency Cesarean section [till delivery 36 to 37 weeks]

    severe antepartum hemorrhage requiring delivery

  3. Premature delivery [37 week's gestation]

    before the planned delivery date (before 37 weeks' gestation)

  4. Need for cesarean hysterectomy [during cesarean section]

    cesarean hysterectomy due to bleeding or placenta accreta spectrum

  5. Postpartum hemorrhage [Within 2 hours of delivery]

    severity of attacks and required further management or blood transfusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Asymptomatic women diagnosed with placenta previa according to RCOG (GTG No. 27a, 2018): placenta lies directly over the internal os for pregnancies more than 16 weeks' gestation on transabdominal or transvaginal scanning.

  • Gestational age between 28 till 37 weeks' gestation (as delivery should be considered between 36 and 37 weeks of gestation for women presenting with uncomplicated placenta previa)

Exclusion Criteria:
  • Multiple pregnancies.

  • Threatened preterm labor or preterm rupture of membranes.

  • History of bleeding in the current pregnancy.

  • Polyhydraminos (AFI > 25 cm).

  • History of cervical surgery (cone biopsy).

  • Presence of cervical cerclage.

  • Maternal use of vaginla progesterone.

  • History of maternal disease (hypertensive, DM, Cardiac).

  • Fetal malformation or growth restriction

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Ain Shams University Cairo Egypt 11591

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MayaAbdElRazek, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05802251
Other Study ID Numbers:
  • MD 172 2022
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Apr 1, 2023
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 Apr 6, 2023