Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women
Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Zhengping Liu, MD
- 電話番号:86 757 82969772
- メール:liuzphlk81@outlook.com
研究連絡先のバックアップ
- 名前:Dazhi Fan, MD
- 電話番号:86 757 82969772
- メール:fandazhigw@163.com
研究場所
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Guangdong
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Foshan、Guangdong、中国、528000
- 募集
- Maternal and Child Health Hospital of Foshan
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コンタクト:
- Zhengping Liu, MD
- 電話番号:86 757 82969772
- メール:liuzphlk81@outlook.com
-
コンタクト:
- Dazhi Fan, MD
- 電話番号:86 757 82969772
- メール:fandazhigw@163.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Exclusion Criteria:
- Multiple pregnancy
- Refuses to consent
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with postpartum hemorrhage
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with antepartum hemorrhage
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:72 hours after delivery
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Yes or no
|
72 hours after delivery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MCHHFoshan-1901
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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