NCT03140033

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hemorrhage Postpartum

Interventions

Type	Name	Description
DRUG	Misoprostol Oral Tablet	at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
DRUG	Ranitidine Oral Tablet	at cord clamping the patient will recieve ranitidine sublingually

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2017-05-04
• Last updated: 2017-05-04

Locations

1 site across 1 country: Egypt