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Clinical Trials/NCT03774667
NCT03774667
Unknown
N/A

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

Maternal and Child Health Hospital of Foshan1 site in 1 country1,500 target enrollmentJanuary 1, 2019
ConditionsPlacenta Previa

Overview

Phase
N/A
Intervention
Not specified
Conditions
Placenta Previa
Sponsor
Maternal and Child Health Hospital of Foshan
Enrollment
1500
Locations
1
Primary Endpoint
Number of Participants with postpartum hemorrhage
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Maternal and Child Health Hospital of Foshan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Single Pregnancy
  • Informed consent
  • Fetal gestational age 28 to \< 42 weeks

Exclusion Criteria

  • Multiple pregnancy
  • Refuses to consent

Outcomes

Primary Outcomes

Number of Participants with postpartum hemorrhage

Time Frame: 24 hours after delivery

Blood loss \> 1000ml during cesarean section or \> 500 ml during vaginal delivery

Secondary Outcomes

  • 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)
  • Number of urological injury(72 hours after delivery)
  • Number of needed for extra surgical maneuvers(72 hours after delivery)
  • Number of Participants with antepartum hemorrhage(From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks)
  • Number of need for caesarean hysterectomy(72 hours after delivery)
  • Number of needed for maternal ICU(72 hours after delivery)
  • Number of Participants with preterm birth(From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks)
  • Number of participant needed for blood transfusion(72 hours after delivery)
  • Number of needed for neonatal ICU(72 hours after delivery)

Study Sites (1)

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