Gastrointestinal Motility and Defecation Conditions Clinical Trial
Official title:
Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial
| NCT number | NCT03442634 |
| Other study ID # | cshydration |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 1, 2018 |
| Est. completion date | June 30, 2018 |
| Verified date | August 2018 |
| Source | Ain Shams University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs while the control group will get 200 ml of sugar free water 6 hours after cs
| Status | Completed |
| Enrollment | 2 |
| Est. completion date | June 30, 2018 |
| Est. primary completion date | June 30, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Term Singleton Pregnancy. - Uncomplicated Elective Cesarean Section. - Time of Cesarean Section doesn't exceed 90 minutes. - Average blood loss during and after cesarean section (doesn't exceed 1000cc). - All patients will be under spinal anesthesia. Exclusion Criteria: - Postpartum Hemorrhage. - Surgical Complications Such as intestinal injury. - Medical disorders such as Diabetes and Hypertension - Factors that may influence postpartum blood loss as anemia, multiple pregnancy and polyhydraminos. - Use of tocolytic drugs |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Ain Shams Maternity Hospital | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | audible intestinal sounds | auscultation of intestinal sounds hourly for the first 12 hours after cesarean section | first 12 hours after cesarean section | |
| Secondary | postoperative anorexia, nausea and vomiting | recording the incidence of git upset symptoms in the first 24 hours after cesarean section | first 24 hours after cesarean section | |
| Secondary | time for first breast feeding | recording the time of first breast-feed | first 24 hours after cesarean section | |
| Secondary | abdominal distension | recording the incidence of abdominal distension after cesarean section | first 24 hours after cesarean section | |
| Secondary | amount of given intravenous fluids | recording amount in ml of given iv fluids | up to 24 hours after cesarean section | |
| Secondary | need for pain analgesics | recording the amount of pain analgesia needed after cesarean section | up to 24 hours after cesarean section | |
| Secondary | length of hospital stay | recording the length of patients' stay at hospital | up to 48 hours after cesarean section | |
| Secondary | satisfaction measured with a visual analogue scale before patient discharge | measuring satisfaction level after cesarean section | first 6 hours after cesarean section | |
| Secondary | time to first flatus | recording the time at which the patient had its first flatus | up to 48 hours after cesarean section | |
| Secondary | time to first bowel movement | recording the time at which the patient had her first bowel motion | up to 72 hours after cesarean section |
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| Completed |
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