Clinical trial NCT03774667: Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women
Official title: Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Previa
Keywords: Placenta Previa
Risk Factors
Perinatal Complications
Perinatal Outcomes
Lead sponsor: Maternal and Child Health Hospital of Foshan
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Multiple pregnancy
* Refuses to consent

Primary outcomes:
measure: Number of Participants with postpartum hemorrhage
timeFrame: 24 hours after delivery
Secondary outcomes:
measure: Number of Participants with antepartum hemorrhage
timeFrame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
measure: Number of Participants with preterm birth
timeFrame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
measure: Number of Participants with very preterm birth
timeFrame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
measure: Number of participant needed for blood transfusion
timeFrame: 72 hours after delivery
measure: Number of urological injury
timeFrame: 72 hours after delivery
measure: Number of needed for extra surgical maneuvers
timeFrame: 72 hours after delivery
measure: Number of need for caesarean hysterectomy
timeFrame: 72 hours after delivery
measure: Number of needed for neonatal ICU
timeFrame: 72 hours after delivery
measure: Number of needed for maternal ICU
timeFrame: 72 hours after delivery
Other outcomes:
Locations:
city: Foshan
country: China
facility: Maternal and Child Health Hospital of Foshan
state: Guangdong
Study officials:
References: