- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Zhengping Liu, MD
- 전화번호: 86 757 82969772
- 이메일: liuzphlk81@outlook.com
연구 연락처 백업
- 이름: Dazhi Fan, MD
- 전화번호: 86 757 82969772
- 이메일: fandazhigw@163.com
연구 장소
-
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Guangdong
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Foshan, Guangdong, 중국, 528000
- 모병
- Maternal and Child Health Hospital of Foshan
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연락하다:
- Zhengping Liu, MD
- 전화번호: 86 757 82969772
- 이메일: liuzphlk81@outlook.com
-
연락하다:
- Dazhi Fan, MD
- 전화번호: 86 757 82969772
- 이메일: fandazhigw@163.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Exclusion Criteria:
- Multiple pregnancy
- Refuses to consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with postpartum hemorrhage
기간: 24 hours after delivery
|
Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
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24 hours after delivery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants with antepartum hemorrhage
기간: 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
|
|
Number of Participants with preterm birth
기간: 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
기간: 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
기간: 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
|
|
Number of urological injury
기간: 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
기간: 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
기간: 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
기간: 72 hours after delivery
|
Yes or no
|
72 hours after delivery
|
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Number of needed for maternal ICU
기간: 72 hours after delivery
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Yes or no
|
72 hours after delivery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MCHHFoshan-1901
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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