Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial
This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
158
at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
at cord clamping the patient will recieve ranitidine sublingually
Ain shams maternity hospital
Cairo, Egypt
RECRUITINGBlood loss during cesarean sections
Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta
Time frame: through study completion, an average of 1 year
Vaginal bleeding
Calculation of the amount of vaginal bleeding according to the number of soaked pads used after cesarea section for the 1st 6 hrs. Each soaked pad equal 50 cc
Time frame: through study completion, an average of 1 year
Change in blood pressure and pulse
Change in blood pressure and pulse before and after the cesarean section
Time frame: through study completion, an average of 1 year
Blood loss after 24 hr.
The allowable blood loss (ABL) =\[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) \] / HI ( initial hematocrit)
Time frame: through study completion, an average of 1 year
Need for additional uterotonic agent
Need for additional uterotonic agent e.g oxytocin - methyl ergotamine
Time frame: through study completion, an average of 1 year
Need for blood transfusion
number of patients receiving blood transfusion
Time frame: through study completion, an average of 1 year
Need for surgical measures to stop bleeding
Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy
Time frame: through study completion, an average of 1 year
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Side effects of misoprostol
Nausea, Vomiting or Diarrhea
Time frame: through study completion, an average of 1 year