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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

Brief Summary:
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Number of Participants with postpartum hemorrhage [ Time Frame: 24 hours after delivery ]
    Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Number of participant needed for blood transfusion [ Time Frame: 72 hours after delivery ]
    Calculation of the number of participant needed for blood transfusion

  5. Number of urological injury [ Time Frame: 72 hours after delivery ]
    Calculation of the number of participant with bladder or ureteric injury

  6. Number of needed for extra surgical maneuvers [ Time Frame: 72 hours after delivery ]
    internal iliac ligation or hysterectomy

  7. Number of need for caesarean hysterectomy [ Time Frame: 72 hours after delivery ]
    Yes or no

  8. Number of needed for neonatal ICU [ Time Frame: 72 hours after delivery ]
    Yes or no

  9. Number of needed for maternal ICU [ Time Frame: 72 hours after delivery ]
    Yes or no



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiple pregnancy
  • Refuses to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774667


Contacts
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Contact: Zhengping Liu, MD 86 757 82969772 liuzphlk81@outlook.com
Contact: Dazhi Fan, MD 86 757 82969772 fandazhigw@163.com

Locations
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China, Guangdong
Maternal and Child Health Hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Zhengping Liu, MD    86 757 82969772    liuzphlk81@outlook.com   
Contact: Dazhi Fan, MD    86 757 82969772    fandazhigw@163.com   
Sponsors and Collaborators
Maternal and Child Health Hospital of Foshan
Additional Information:

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Responsible Party: Maternal and Child Health Hospital of Foshan
ClinicalTrials.gov Identifier: NCT03774667    
Other Study ID Numbers: MCHHFoshan-1901
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Six months after completion of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maternal and Child Health Hospital of Foshan:
Placenta Previa
Risk Factors
Perinatal Complications
Perinatal Outcomes
Additional relevant MeSH terms:
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Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases