Clinical trial NCT05802251: Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study
Official title: Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Placenta Previa
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 68
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asymptomatic pregnant women diagnosed with placenta previa between 28 to 37 weeks' gestation.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: maternal bleeding rate
timeFrame: till delivery
Secondary outcomes:
measure: Blood transfusion
timeFrame: till delivery 36 to 37 weeks
measure: Emergency Cesarean section
timeFrame: till delivery 36 to 37 weeks
measure: Premature delivery
timeFrame: 37 week's gestation
measure: Need for cesarean hysterectomy
timeFrame: during cesarean section
measure: Postpartum hemorrhage
timeFrame: Within 2 hours of delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
Study officials:
References: