- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03774667
Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women
Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Zhengping Liu, MD
- Telefonnummer: 86 757 82969772
- E-post: liuzphlk81@outlook.com
Studera Kontakt Backup
- Namn: Dazhi Fan, MD
- Telefonnummer: 86 757 82969772
- E-post: fandazhigw@163.com
Studieorter
-
-
Guangdong
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Foshan, Guangdong, Kina, 528000
- Rekrytering
- Maternal and Child Health Hospital of Foshan
-
Kontakt:
- Zhengping Liu, MD
- Telefonnummer: 86 757 82969772
- E-post: liuzphlk81@outlook.com
-
Kontakt:
- Dazhi Fan, MD
- Telefonnummer: 86 757 82969772
- E-post: fandazhigw@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Exclusion Criteria:
- Multiple pregnancy
- Refuses to consent
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Placenta Previa
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
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants with postpartum hemorrhage
Tidsram: 24 hours after delivery
|
Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
|
24 hours after delivery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants with antepartum hemorrhage
Tidsram: 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
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From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
|
Number of Participants with preterm birth
Tidsram: From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
|
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
Tidsram: From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
|
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
Tidsram: 72 hours after delivery
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Calculation of the number of participant needed for blood transfusion
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72 hours after delivery
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Number of urological injury
Tidsram: 72 hours after delivery
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Calculation of the number of participant with bladder or ureteric injury
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72 hours after delivery
|
Number of needed for extra surgical maneuvers
Tidsram: 72 hours after delivery
|
internal iliac ligation or hysterectomy
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72 hours after delivery
|
Number of need for caesarean hysterectomy
Tidsram: 72 hours after delivery
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Yes or no
|
72 hours after delivery
|
Number of needed for neonatal ICU
Tidsram: 72 hours after delivery
|
Yes or no
|
72 hours after delivery
|
Number of needed for maternal ICU
Tidsram: 72 hours after delivery
|
Yes or no
|
72 hours after delivery
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MCHHFoshan-1901
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IPD-delning som stöder informationstyp
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