Early Feeding After A Cesarean Delivery Hastens Recovery Time for Bowel Function
Early Versus Late Feeding After Cesarean Delivery: A Randomized Controlled Trial
After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached for participation in the study. The study informed consent will be obtained. The study's time frame inclusive will be from 2013 till 2016.
Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.
Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be performed using a computer generated random list of numbers assigning patients to the 2 groups of the study. This list of random number assignments will be kept secure in an opaque envelope until the end of the study. Patients in the Early group will be started on regular diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO 12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as tolerated, i.e. if clears were tolerated or flatus or bowel movement occurred, patients will be started on solid foods. If diet not tolerated, a full liquid diet will be given instead. Consequently if patient tolerated full liquid diet, a regular diet will be then initiated. Patients will be discharged home only if they tolerate solid food with absence of emesis, have flatus or bowel movement. Time Zero is defined as time of skin incision.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Gravid women greater than 37 weeks undergoing elective cesarean delivery.
Exclusion Criteria:
- Intra-operative bowel surgery
- Preeclampsia requiring magnesium sulfate
- Diabetes Mellitus.
- Planned secondary closure of the skin incision
- Any gastrointestinal and/or medical conditions that precludes early consumption of solid food
- General anesthesia
- Gestational age less than 37 weeks.
- Patients who are mentally incapacitated or decisionally impaired.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Early Feeding Arm
Patients will be started on regular diet within 6 hrs postoperative.
|
Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.
|
|
간섭 없음: Late Feeding Group
Patients will be remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs as standard postoperative protocol in the investigators' institution.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Passing Flatus
기간: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
The primary outcome is the duration in minutes from surgery completion(skin closure) and time of passage of first flatus (passing gas per anus).
|
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bowel sounds
기간: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
First time in minutes from completion of surgery that bowel sounds are heard active.
|
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
|
Bowel Evacuation
기간: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
First time in minutes from completion of surgery that patient reports passing bowel movement or stools.
|
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
|
Nausea or vomiting
기간: participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
First time in minutes from completion of surgery that patient reports nauseated or has actually had emesis.
|
participants will be followed for the duration of hospital stay, an expected average of 2-5 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Antonio F Saad, MD, UTMB Galveston Texas
간행물 및 유용한 링크
일반 간행물
- Hsu YY, Hung HY, Chang SC, Chang YJ. Early oral intake and gastrointestinal function after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2013 Jun;121(6):1327-1334. doi: 10.1097/AOG.0b013e318293698c.
- Bar G, Sheiner E, Lezerovizt A, Lazer T, Hallak M. Early maternal feeding following caesarean delivery: a prospective randomised study. Acta Obstet Gynecol Scand. 2008;87(1):68-71. doi: 10.1080/00016340701778849.
- Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. doi: 10.1016/s0029-7844(01)01387-4.
- Saad AF, Saoud F, Diken ZM, Hegde S, Kuhlmann MJ, Wen TS, Hankins GD, Saade GR, Costantine MM. Early versus Late Feeding after Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2016 Mar;33(4):415-9. doi: 10.1055/s-0035-1565918. Epub 2015 Oct 19.
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 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. .
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