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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Zhengping Liu, MD
- Telefoonnummer: 86 757 82969772
- E-mail: liuzphlk81@outlook.com
Studie Contact Back-up
- Naam: Dazhi Fan, MD
- Telefoonnummer: 86 757 82969772
- E-mail: fandazhigw@163.com
Studie Locaties
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Guangdong
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Foshan, Guangdong, China, 528000
- Werving
- Maternal and Child Health Hospital of Foshan
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Contact:
- Zhengping Liu, MD
- Telefoonnummer: 86 757 82969772
- E-mail: liuzphlk81@outlook.com
-
Contact:
- Dazhi Fan, MD
- Telefoonnummer: 86 757 82969772
- E-mail: fandazhigw@163.com
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Exclusion Criteria:
- Multiple pregnancy
- Refuses to consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants with postpartum hemorrhage
Tijdsspanne: 24 hours after delivery
|
Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
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24 hours after delivery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants with antepartum hemorrhage
Tijdsspanne: 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
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Number of Participants with preterm birth
Tijdsspanne: From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
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Before 37 completed gestational weeks
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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
Tijdsspanne: From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
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Before 32 completed gestational weeks
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From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
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Number of participant needed for blood transfusion
Tijdsspanne: 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
Tijdsspanne: 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
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Number of needed for extra surgical maneuvers
Tijdsspanne: 72 hours after delivery
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internal iliac ligation or hysterectomy
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72 hours after delivery
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Number of need for caesarean hysterectomy
Tijdsspanne: 72 hours after delivery
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Yes or no
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72 hours after delivery
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Number of needed for neonatal ICU
Tijdsspanne: 72 hours after delivery
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Yes or no
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72 hours after delivery
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Number of needed for maternal ICU
Tijdsspanne: 72 hours after delivery
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Yes or no
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72 hours after delivery
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MCHHFoshan-1901
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
IPD-tijdsbestek voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Placenta praevia
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Yonsei UniversityVoltooidKeizersnede met placenta previaKorea, republiek van
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Kasr El Aini HospitalOnbekendPlacenta Accreta in Placenta Previa Anterior
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Woman's Health University Hospital, EgyptVoltooidPlacenta Previa Totaal | Verpleegkundige rolEgypte
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Zagazig UniversityNog niet aan het wervenCervicale IO Plasty bij de behandeling van Placenta Previa
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Maternal and Child Health Hospital of FoshanVoltooidVoltooi Placenta PreviaChina
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King Edward Medical UniversityVoltooidPlacenta accreta | Placenta Previa met bloeding - afgeleverdPakistan
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Hawler Medical UniversityVoltooidInterventioneel geneesmiddel in Placenta PreviaIrak
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Assiut UniversityVoltooid
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Assiut UniversityNog niet aan het wervenPlacenta Previa Bloeden
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Minia Maternity University HospitalVoltooidPlacenta Previa zonder bloedingEgypte