Post Operative Hemorrhage Clinical Trial
Official title:
Mechanical Dilatation vs Non-Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
Verified date | July 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
obstetric hemorrhage remains one of the major causes of maternal death in both developed and
developing countries. Because of its importance as a leading cause of maternal mortality and
morbidity, and because of evidence of substandard care in the majority of fatal cases,
obstetric hemorrhage must be considered as a priority topic for national guideline
development.
Some obstetricians believe that the cervix of women at non-labor cesarean section is
undilated and might cause obstruction of blood or lochia drainage, leading to postpartum
hemorrhage and endometritis from the collection of lochia or debris. Dilatation of the cervix
helps with the drainage of blood during postpartum, reducing intrauterine infection or the
risk of postpartum hemorrhage. To avoid this problem, some obstetricians routinely dilate the
cervix from above during an elective/ non-labor cesarean section using finger, sponge forceps
or other instruments
Status | Completed |
Enrollment | 774 |
Est. completion date | June 20, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
Inclusion Criteria: - pregnant women with a single term fetus >37 weeks of gestational age, with American Society of Anesthesiology (ASA) physical status I or II undergoing Elective Cs (primary or repeated CS). - Age group 20 - 35 years old Exclusion Criteria: - Chorioamnionitis. - Placenta previa. - Multiple gestations. - Preeclampsia. - Macrosomia. - Hydramnios. - Uterine leiomyomata. - Anemia. - Previous cervical surgery. - Previous post-partum hemorrhage. - Bleeding tendency. - Hypertension. - Diabetes mellitus. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal bleeding during the 1st 24 hours postoperative. | The amount of vaginal bleeding will be calculated according to number of soaked pads used after the cesarean section for the 1st 24 hours. Where each soaked pad = 50 cc | the 1st 24 hours postoperative. | |
Secondary | intraoperative blood loss | Blood loss will be estimated by the anesthesia service to guard against potential surgeon bias. Operative blood loss will be calculated from the amount of blood in the suction bottle after delivery of the placenta and the number of towels used and to which degree they were socked. Blood from the uterine incision, soaked towels and blood in suction bottle before placental delivery will not be added to the blood measurements. Soaked towel = 150 cc. Semi-soaked towel = 75 cc. blood measurements. Soaked towel = 150 cc. Semi-soaked towel = 75 cc. |
during the time of the operation | |
Secondary | Total blood loss | intraoperative blood loss plus potoperative blood loss | operation time plus the 1st 24 hours after operation |
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