Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Study Overview
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Brief Summary
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Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial

Detailed Description
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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.

Official Title
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Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study

Conditions
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Hemorrhage Postpartum

Intervention / Treatment
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* Drug: Misoprostol Oral Tablet
* Drug: Ranitidine Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol oral tablets<br>79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping | Drug: Misoprostol Oral Tablet<br>* at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually<br>* Other names: Misotac;|
| Placebo Comparator: Ranitidine oral tablets<br>79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping | Drug: Ranitidine Oral Tablet<br>* at cord clamping the patient will recieve ranitidine sublingually<br>* Other names: Ranitak;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss during cesarean sections | Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | through study completion, an average of 1 year | 
| Need for additional uterotonic agent | Need for additional uterotonic agent e.g oxytocin - methyl ergotamine | through study completion, an average of 1 year | 
| Need for blood transfusion | number of patients receiving blood transfusion | 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 | through study completion, an average of 1 year | 
| Side effects of misoprostol | Nausea, Vomiting or Diarrhea | through study completion, an average of 1 year |