Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women

Study Overview
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Brief Summary
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This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.

Detailed Description
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Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades according to the relationship and the distance between the lower placental edge and the internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and complete previa. Cesarean delivery and assisted reproductive technology are associated with an increased risk of placenta previa in subsequent pregnancies. Other risk factors for previa include previous spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa. It is associated with numerous adverse maternal and fetal-neonatal complications, such as perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and even fetal-neonatal and maternal death. This is a 1:2 prospective, matched and hospital-based case-control study to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. For each placenta previa women, the investigators selected two none-placenta previa pregnant women as control from the same department matched on the mode of delivery, using simple random selection when excess matches are available. The date of their admission is limited to two days. This hospital is a tertiary university-affiliated medical center with a stable number of approximately 12,000 deliveries per year. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.

Official Title
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Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study

Conditions
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Placenta Previa

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single Pregnancy Informed consent Fetal gestational age 28 to < 42 weeks Exclusion Criteria: Multiple pregnancy Refuses to consent

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placenta Previa<br>Pregnant women is diagnosed with placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery. | |
| None-Placenta Previa<br>Pregnant women is diagnosed without placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with postpartum hemorrhage | Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery | 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with antepartum hemorrhage | At least one episode of bleeding from the genital tract during the antenatal period | From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks | 
| Number of Participants with preterm birth | Before 37 completed gestational weeks | From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks | 
| Number of Participants with very preterm birth | Before 32 completed gestational weeks | From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks | 
| Number of participant needed for blood transfusion | Calculation of the number of participant needed for blood transfusion | 72 hours after delivery | 
| Number of urological injury | Calculation of the number of participant with bladder or ureteric injury | 72 hours after delivery | 
| Number of needed for extra surgical maneuvers | internal iliac ligation or hysterectomy | 72 hours after delivery | 
| Number of need for caesarean hysterectomy | Yes or no | 72 hours after delivery | 
| Number of needed for neonatal ICU | Yes or no | 72 hours after delivery | 
| Number of needed for maternal ICU | Yes or no | 72 hours after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placenta Previa, Risk Factors, Perinatal Complications, Perinatal Outcomes