- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01834599
Could the Cerebral Oximetry be a Good Technology to Measure Placental Oxygenation?
Could the Cerebral Oximetry (NIRS) be a Good Technology to Measure Placental Oxygenation in Pregnant Woman?
연구 개요
상세 설명
There is general agreement among experts to recommend the use of phenylephrine as first line therapy for the treatment of arterial hypotension induced by spinal anaesthesia during caesarean delivery. In some studies, there are trends toward a lower PaO2 values in the umbilical cord venous blood when the mother receive this vasopressor. These findings may be a result of the vasoconstrictor effect of phenylephrine on utero-placental vessels, and a subsequent increased oxygen extraction by the fetus. The possibility to extract more oxygen would provide a certain "safety margin" in the event of compromised utero-placental blood flow during normal pregnancy. However, this "safety margin" should not be taken for granted in cases where signs of fetal distress are present, and this situation might influence the choice of vasopressors.
It is well establish on a physiological basis that during labour, utero-placental blood flow is lower during the contractions. This lower blood flow could result in a lower saturation value measured by the cerebral oximeter.
Twenty patients in labour will be included in this study. Patients will be recruited in obstetric clinic during pregnancy. Based on the second trimester ultrasound, patients with anterior placenta will be included.
During labour, once a functional epidural is in place, an Invos oximeter will be install. Two sensors will be applied on the abdomen (one above the placenta and the other above the myometrium at a place without placenta). Two sensors will also be applied on the extremities (forearm and leg).Saturation values and timing of the contractions will be recorded for sixty minutes. Half of the recording will be done with an oxygen mask. Vitals signs will also be registered every five minutes.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H1T 2M4
- Maisonneuve Rosemont Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- healthy pregnant woman (ASA I or II)
- Term gestation ( > 37 weeks)
- Normal pregnancy
- vaginal delivery
- obstetrical epidural in place
- anterior placenta
Exclusion Criteria:
- patient refusal
- Any contraindication to neuraxial anesthesia
- cesarean section
- multiple gestation
- placentation abnormalities
- anormal placental perfusion
- Placental Abruption
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
anterior placenta
Cerebral oximetry device used to obtain: Saturation value of the placenta probe with no oxygen, saturation value of the placenta probe with oxygen, saturation value of the myometrium probe with no oxygen saturation value of the myometrium probe with oxygen saturation value of the forearm probe with no oxygen, saturation value of the forearm probe with oxygen saturation value of the leg probe with no oxygen saturation value of the leg probe with oxygen Timing between the contractions measure by cardiotocography |
tissue saturation measurement in pregnant women
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference between Δp and Δm
기간: 60 minutes
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Δp = Difference between the mean value area under the curve for the placenta and arm = (Ap- Af) Δm= Difference between the mean value area under the curve for the myometrium and arm = (Am- Af)
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60 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference of the area under the curve of saturation with and without oxygen
기간: 60 minutes
|
Ap with Oxygen - Ap without oxygen; Am with oxygen - Am without oxygen
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60 minutes
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LoubertHMR2013/04
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cerebral oximetry에 대한 임상 시험
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