- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01991743
A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version
A Randomized Controlled Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version
We plan to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction during, external version for breech fetal position and the incidence of vaginal vs. Cesarean delivery.
The research aim of this project is to determine the ideal neuraxial dosing strategy to maximize success of external cephalic version (ECV).
The research questions, does a combined spinal-epidural (CSE) of a higher dose result in greater success in converting a breech presentation to vertex during external cephalic version (ECV).
The hypotheses of this project is that CSE at higher dose will result in greater ECV success than analgesic dosing.
The research significance:Increasing the success and comfort of ECV for fetal malpresentation may help decrease the cesarean section rate.
연구 개요
상세 설명
At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. However, cesarean delivery, the safer option for the baby, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. External cephalic version (ECV) is a procedure commonly used to attempt to manually rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications. (Hofmeyr Cochrane Review) Obstetricians generally perform versions after 36 weeks gestational age with a reportable success rate of 50-80%, depending on several factors, including patient characteristics. (Fortunato, Zhang, ACOG 1997 ECV) The most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. Until recently, pain relief was generally provided in the form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia.
Two non-randomized studies of neuraxial analgesia compared to systemic analgesia found improved success of external cephalic version in the neuraxial analgesia groups.(Carlan, Birnbach) Three randomized trials have conflicting results: 2 demonstrate an increase in success, one shows no difference. (Dugoff, Schorr, Mancuso) None of these studies have blinded the obstetrician performing the version. In 2010, Lavoie and colleagues completed a meta-analysis looking at ECV performed under analgesic and anesthetic neuraxial doses. The analgesic dose included spinal bupivacaine and epidural dosing. The anesthestic groups gave higher doses of spinal or epidural bupivacaine. This meta-analysis suggested that those patients who had received an anesthetic dose of had more successful ECV. All published studies examining pain outcomes have demonstrated that neuraxial analgesia results in greater patient comfort during this procedure.
The American College of Obstetricians and Gynecologists (ACOG) has stated, "Currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ECV (external cephalic version) attempts."
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Illinois
-
Chicago, Illinois, 미국, 60611
- Prentice Women's Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy patients age 18 and older
- Breech presentation
- Singleton gestation .scheduled for ECV desiring CSE.
Exclusion Criteria:
- Refusal
- Contraindication to neuraxial (coagulopathy, anticoagulant use, local infection, sepsis etc) .Rupture of membranes.
- Drop-out: Patients may choose to drop-out of the study at any time. The physicians involved in this study may choose to end a patient's involvement in the study at their discretion.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Drug:Group 2.5
Administration of 2.5 mg bupivacaine
|
Administration of bupivacaine 2.5 mg.
다른 이름들:
|
활성 비교기: Group 5
Administration of 5 mg bupivacaine.
|
Administration of 5 mg bupivacaine
다른 이름들:
|
활성 비교기: Group 7.5
Administration of 7.5mg bupivacaine.
|
Administration of 7.5 mg bupivacaine
다른 이름들:
|
활성 비교기: Group 10
Administration of 10 mg bupivacaine.
|
Administration of 10mg bupivacaine.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Success Rate of External Cephalic Version
기간: Completion of the procedure
|
Rates of successful version evaluated among the 4 dose groups.
|
Completion of the procedure
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mode of Delivery
기간: To time of delivery
|
To time of delivery
|
|
Indication of Cesarean Delivery
기간: To time of delivery
|
To time of delivery
|
|
Pain Score During the Procedure
기간: < 20 minutes
|
pain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale)
|
< 20 minutes
|
Abdominal Relaxation
기간: <20 minutes
|
Obstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100)
|
<20 minutes
|
공동 작업자 및 조사자
수사관
- 연구 책임자: David Walega, MD, Northwestern University
간행물 및 유용한 링크
일반 간행물
- Lavoie A, Guay J. Anesthetic dose neuraxial blockade increases the success rate of external fetal version: a meta-analysis. Can J Anaesth. 2010 May;57(5):408-14. doi: 10.1007/s12630-010-9278-4. Epub 2010 Feb 3.
- Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.
- Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12.
- Carlan SJ, Dent JM, Huckaby T, Whittington EC, Shaefer D. The effect of epidural anesthesia on safety and success of external cephalic version at term. Anesth Analg. 1994 Sep;79(3):525-8. doi: 10.1213/00000539-199409000-00021.
- Birnbach DJ, Matut J, Stein DJ, Campagnuolo J, Drimbarean C, Grunebaum A, Kuroda MM, Thys DM. The effect of intrathecal analgesia on the success of external cephalic version. Anesth Analg. 2001 Aug;93(2):410-3, 4th contents page. doi: 10.1097/00000539-200108000-00035.
- Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2002;(2):CD000184. doi: 10.1002/14651858.CD000184.
- ACOG practice patterns. External cephalic version. Number 4, July 1997. American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1997 Oct;59(1):73-80. No abstract available.
- Dugoff L, Stamm CA, Jones OW 3rd, Mohling SI, Hawkins JL. The effect of spinal anesthesia on the success rate of external cephalic version: a randomized trial. Obstet Gynecol. 1999 Mar;93(3):345-9. doi: 10.1016/s0029-7844(98)00456-6.
- Schorr SJ, Speights SE, Ross EL, Bofill JA, Rust OA, Norman PF, Morrison JC. A randomized trial of epidural anesthesia to improve external cephalic version success. Am J Obstet Gynecol. 1997 Nov;177(5):1133-7. doi: 10.1016/s0002-9378(97)70029-2.
- Mancuso KM, Yancey MK, Murphy JA, Markenson GR. Epidural analgesia for cephalic version: a randomized trial. Obstet Gynecol. 2000 May;95(5):648-51. doi: 10.1016/s0029-7844(99)00611-0.
- Sullivan JT, Grobman WA, Bauchat JR, Scavone BM, Grouper S, McCarthy RJ, Wong CA. A randomized controlled trial of the effect of combined spinal-epidural analgesia on the success of external cephalic version for breech presentation. Int J Obstet Anesth. 2009 Oct;18(4):328-34. doi: 10.1016/j.ijoa.2009.02.006. Epub 2009 Aug 13.
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- STU00050371
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Group 2.5에 대한 임상 시험
-
Aarhus University HospitalUniversity of Aarhus완전한
-
Maharishi Markendeswar University (Deemed to be...완전한
-
Soroka University Medical Center알려지지 않은
-
USDA Beltsville Human Nutrition Research CenterPenn State University완전한