Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women
- Conditions
- Placenta Previa
- Registration Number
- NCT03774667
- Lead Sponsor
- Maternal and Child Health Hospital of Foshan
- Brief Summary
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1500
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
- Multiple pregnancy
- Refuses to consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with postpartum hemorrhage 24 hours after delivery Blood loss \> 1000ml during cesarean section or \> 500 ml during vaginal delivery
- Secondary Outcome Measures
Name Time Method Number of Participants with very preterm birth From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks Before 32 completed gestational weeks
Number of urological injury 72 hours after delivery Calculation of the number of participant with bladder or ureteric injury
Number of needed for extra surgical maneuvers 72 hours after delivery internal iliac ligation or hysterectomy
Number of Participants with antepartum hemorrhage From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks At least one episode of bleeding from the genital tract during the antenatal period
Number of need for caesarean hysterectomy 72 hours after delivery Yes or no
Number of needed for maternal ICU 72 hours after delivery Yes or no
Number of Participants with preterm birth From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks Before 37 completed gestational weeks
Number of participant needed for blood transfusion 72 hours after delivery Calculation of the number of participant needed for blood transfusion
Number of needed for neonatal ICU 72 hours after delivery Yes or no
Trial Locations
- Locations (1)
Maternal and Child Health Hospital of Foshan
🇨🇳Foshan, Guangdong, China