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Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women

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ClinicalTrials.gov Identifier: NCT03774667
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Maternal and Child Health Hospital of Foshan

Tracking Information
First Submitted Date December 5, 2018
First Posted Date December 13, 2018
Last Update Posted Date February 21, 2020
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2018)
Number of Participants with postpartum hemorrhage [ Time Frame: 24 hours after delivery ]
Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 12, 2018)
  • Number of Participants with antepartum hemorrhage [ Time Frame: 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
  • Number of Participants with preterm birth [ Time Frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks ]
    Before 37 completed gestational weeks
  • Number of Participants with very preterm birth [ Time Frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks ]
    Before 32 completed gestational weeks
  • Number of participant needed for blood transfusion [ Time Frame: 72 hours after delivery ]
    Calculation of the number of participant needed for blood transfusion
  • Number of urological injury [ Time Frame: 72 hours after delivery ]
    Calculation of the number of participant with bladder or ureteric injury
  • Number of needed for extra surgical maneuvers [ Time Frame: 72 hours after delivery ]
    internal iliac ligation or hysterectomy
  • Number of need for caesarean hysterectomy [ Time Frame: 72 hours after delivery ]
    Yes or no
  • Number of needed for neonatal ICU [ Time Frame: 72 hours after delivery ]
    Yes or no
  • Number of needed for maternal ICU [ Time Frame: 72 hours after delivery ]
    Yes or no
Original Secondary Outcome Measures
 (submitted: December 11, 2018)
  • Number of Participants with antepartum hemorrhage [ Time Frame: 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
  • Number of Participants with preterm birth [ Time Frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks ]
    Before 37 completed gestational weeks
  • Number of Participants with very preterm birth [ Time Frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks ]
    Before 32 completed gestational weeks
  • Number of participant needed for blood transfusion [ Time Frame: 72 hours after delivery ]
    Calculation of the number of participant needed for blood transfusion
  • Number of urological injury [ Time Frame: 72 hours after delivery ]
    Calculation of the number of participant with badder or ureteric injury
  • Number of needed for extra surgical maneuvers [ Time Frame: 72 hours after delivery ]
    internal iliac ligation or hysterectomy
  • Number of need for caesarean hysterectomy [ Time Frame: 72 hours after delivery ]
    Yes or no
  • Number of needed for neonatal ICU [ Time Frame: 72 hours after delivery ]
    Yes or no
  • Number of needed for maternal ICU [ Time Frame: 72 hours after delivery ]
    Yes or no
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.
Condition Placenta Previa
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 11, 2018)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiple pregnancy
  • Refuses to consent
Sex/Gender
Sexes Eligible for Study: Female
Ages 12 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Zhengping Liu, MD 86 757 82969772 liuzphlk81@outlook.com
Contact: Dazhi Fan, MD 86 757 82969772 fandazhigw@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03774667
Other Study ID Numbers MCHHFoshan-1901
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Six months after completion of the study
Responsible Party Maternal and Child Health Hospital of Foshan
Study Sponsor Maternal and Child Health Hospital of Foshan
Collaborators Not Provided
Investigators Not Provided
PRS Account Maternal and Child Health Hospital of Foshan
Verification Date February 2020