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Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03774667
Enrollment
1500
Registered
2018-12-13
Start date
2019-01-01
Completion date
2022-06-30
Last updated
2021-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Previa

Keywords

Placenta Previa, Risk Factors, Perinatal Complications, Perinatal Outcomes

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.

Interventions

None listed

Sponsors

Maternal and Child Health Hospital of Foshan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

* Multiple pregnancy * Refuses to consent

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with postpartum hemorrhage24 hours after deliveryBlood loss \> 1000ml during cesarean section or \> 500 ml during vaginal delivery

Secondary

MeasureTime frameDescription
Number of needed for maternal ICU72 hours after deliveryYes or no
Number of Participants with antepartum hemorrhageFrom the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeksAt least one episode of bleeding from the genital tract during the antenatal period
Number of Participants with preterm birthFrom the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeksBefore 37 completed gestational weeks
Number of Participants with very preterm birthFrom the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeksBefore 32 completed gestational weeks
Number of needed for neonatal ICU72 hours after deliveryYes or no
Number of urological injury72 hours after deliveryCalculation of the number of participant with bladder or ureteric injury
Number of needed for extra surgical maneuvers72 hours after deliveryinternal iliac ligation or hysterectomy
Number of need for caesarean hysterectomy72 hours after deliveryYes or no
Number of participant needed for blood transfusion72 hours after deliveryCalculation of the number of participant needed for blood transfusion

Countries

China

Contacts

Primary ContactZhengping Liu, MD
liuzphlk81@outlook.com86 757 82969772
Backup ContactDazhi Fan, MD
fandazhigw@163.com86 757 82969772

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026