Mechanical Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
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|ClinicalTrials.gov Identifier: NCT03444792|
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : July 6, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Hemorrhage||Procedure: mechanical dilatation of the cervix||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||774 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized controlled trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The included patients will be randomized using sealed opaque envelope method into two groups|
|Official Title:||Mechanical Dilatation vs Non-Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss|
|Actual Study Start Date :||February 10, 2018|
|Actual Primary Completion Date :||June 15, 2018|
|Actual Study Completion Date :||June 20, 2018|
Experimental: Group I (dilation group)
the surgeon will perform the cervical dilatation by inserting the double-gloved index ﬁnger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure. - If failed we will use artery forceps to dilate cervix
Procedure: mechanical dilatation of the cervix
the surgeon will perform the cervical dilatation by inserting the double-gloved index ﬁnger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure.
- If failed the surgeon will use artery forceps to dilate cervix
No Intervention: Group II (non dilatation group)
the surgeon will perform cesarian section without attempting cervical dilatation
- Vaginal bleeding during the 1st 24 hours postoperative. [ Time Frame: 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
- intraoperative blood loss [ Time Frame: during the time of the operation ]
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.
- Total blood loss [ Time Frame: operation time plus the 1st 24 hours after operation ]intraoperative blood loss plus potoperative blood loss
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444792
|Faculty of Medicine Cairo University|
|Cairo, Egypt, 11231|
|Principal Investigator:||mohamed sharkawy, assis.prof.||Cairo University|