Clinical Trial: Comparing Blood Loss During Caesarean Section Between Manual Separation of Placenta & Conservative Management
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparing Blood Loss Between Manual Separation & Conservative Management for Removal of the Placenta During Caesarean Section; a Randomized Controlled Study
Brief Summary: to compare the blood loss during caesarean section between two different methods of separating the placenta after fetal extraction, keeping in mind that most blood loss occurs after placental separation.
Detailed Summary:
We are planning a study of a continuous response variable from independent control and experimental subjects with 1 control(s) per experimental subject. In a previous study1 the response within each subject group was normally distributed with standard deviation up to 272. If the true difference in the experimental and control means is 37, we will need to study 249 experimental subjects and 249 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.5. To allow for 15% drop, the sample on each arm will be increased to 287.
After approval of the ethical & scientific committee of the obstetrics & gynecology department, Kasr Alainy Hospital, Cairo University. A randomized controlled trial involving at least 574 patients will be undertaken in which, all patients will be randomized in to two groups, with a closed envelope system containing equal number allocations for both groups (1:1 bias) by the operating room nurse. Informed consent will be taken from all patients before caesarean section.
Group A will contain 287 patients in which manual separation of the placenta will be done immediately after fetal extraction & cord clamping, where the fingers of the surgeon will be insinuated between the margin of the placenta and the uterine cavity, then by sawing movement and controlled traction by the other hand till placenta is separated from the uterine cavity. Group B will also contain 287 patients but following fetal extraction and cord clamping, the placenta will be left insitu & uterus is massaged awaiting spontaneous placental separation.
In both groups a uterotonic agent Oxyt
Sponsor: Kasr El Aini Hospital
Current Primary Outcome: Blood Loss [ Time Frame: 10 minutes ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Kasr El Aini Hospital
Dates:
Date Received: June 22, 2015
Date Started: July 2015
Date Completion:
Last Updated: March 2, 2016
Last Verified: August 2015
