- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Zhengping Liu, MD
- Numero di telefono: 86 757 82969772
- Email: liuzphlk81@outlook.com
Backup dei contatti dello studio
- Nome: Dazhi Fan, MD
- Numero di telefono: 86 757 82969772
- Email: fandazhigw@163.com
Luoghi di studio
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Guangdong
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Foshan, Guangdong, Cina, 528000
- Reclutamento
- Maternal and Child Health Hospital of Foshan
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Contatto:
- Zhengping Liu, MD
- Numero di telefono: 86 757 82969772
- Email: liuzphlk81@outlook.com
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Contatto:
- Dazhi Fan, MD
- Numero di telefono: 86 757 82969772
- Email: fandazhigw@163.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Exclusion Criteria:
- Multiple pregnancy
- Refuses to consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants with postpartum hemorrhage
Lasso di tempo: 24 hours after delivery
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Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
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24 hours after delivery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants with antepartum hemorrhage
Lasso di tempo: From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
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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
Lasso di tempo: 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
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Number of Participants with very preterm birth
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 72 hours after delivery
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Yes or no
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72 hours after delivery
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MCHHFoshan-1901
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Periodo di condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Placenta previa
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriAttivo, non reclutanteServizi Sanitari Preventivi (PREV HEALTH SERV)Stati Uniti