Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery
- Conditions
- Hemorrhage Postpartum
- Interventions
- Registration Number
- NCT03140033
- Lead Sponsor
- Ain Shams Maternity Hospital
- Brief Summary
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 158
- singleton pregnancies
- women booked for elective C.S
- full term pregnancies
- primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )
- blood disorders
- multiple pregnancy
- placenta previa
- polyhydramnios
- marked maternal anemia
- contraindications to prostaglandin e.g history of asthma , allergy to misoprostol
- previous 2 or more C.S
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol oral tablets Misoprostol Oral Tablet 79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping Ranitidine oral tablets Ranitidine Oral Tablet 79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping
- Primary Outcome Measures
Name Time Method Blood loss during cesarean sections through study completion, an average of 1 year Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta
- Secondary Outcome Measures
Name Time Method Change in blood pressure and pulse through study completion, an average of 1 year Change in blood pressure and pulse before and after the cesarean section
Blood loss after 24 hr. through study completion, an average of 1 year The allowable blood loss (ABL) =\[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) \] / HI ( initial hematocrit)
Need for additional uterotonic agent through study completion, an average of 1 year Need for additional uterotonic agent e.g oxytocin - methyl ergotamine
Vaginal bleeding through study completion, an average of 1 year 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
Need for blood transfusion through study completion, an average of 1 year number of patients receiving blood transfusion
Need for surgical measures to stop bleeding through study completion, an average of 1 year Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy
Side effects of misoprostol through study completion, an average of 1 year Nausea, Vomiting or Diarrhea
Trial Locations
- Locations (1)
Ain shams maternity hospital
🇪🇬Cairo, Egypt