Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Overview

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial

Full Title of Study: “Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2017

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Misoprostol oral tablets
    • 79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping
  • Placebo Comparator: Ranitidine oral tablets
    • 79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping

Clinical Trial Outcome Measures

Primary Measures

  • Blood loss during cesarean sections
    • Time Frame: 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 Measures

  • Vaginal bleeding
    • Time Frame: 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
  • Change in blood pressure and pulse
    • Time Frame: 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.
    • Time Frame: 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
    • Time Frame: through study completion, an average of 1 year
    • Need for additional uterotonic agent e.g oxytocin – methyl ergotamine
  • Need for blood transfusion
    • Time Frame: through study completion, an average of 1 year
    • number of patients receiving blood transfusion
  • Need for surgical measures to stop bleeding
    • Time Frame: 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
    • Time Frame: through study completion, an average of 1 year
    • Nausea, Vomiting or Diarrhea

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams Maternity Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed Fathy, Resident of obstetrics and gynecology – Ain Shams Maternity Hospital
  • Overall Official(s)
    • Amr H YEHIA, MD,MRCOG, Study Director, Ain Shams University-Maternity Hospital
  • Overall Contact(s)
    • Mohamed H Fathy, M.B.B.Ch, 00201099984100, Mohamedfathy31085@gmail.com

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