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Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Primary Purpose

Hemorrhage Postpartum

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol Oral Tablet
Ranitidine Oral Tablet
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage Postpartum

Eligibility Criteria

19 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ain shams maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Misoprostol oral tablets

Ranitidine oral tablets

Arm Description

79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping

79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping

Outcomes

Primary Outcome Measures

Blood loss during cesarean sections
Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta

Secondary Outcome Measures

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
Change in blood pressure and pulse
Change in blood pressure and pulse before and after the cesarean section
Blood loss after 24 hr.
The allowable blood loss (ABL) =[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) ] / HI ( initial hematocrit)
Need for additional uterotonic agent
Need for additional uterotonic agent e.g oxytocin - methyl ergotamine
Need for blood transfusion
number of patients receiving blood transfusion
Need for surgical measures to stop bleeding
Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy
Side effects of misoprostol
Nausea, Vomiting or Diarrhea

Full Information

First Posted
April 24, 2017
Last Updated
May 2, 2017
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03140033
Brief Title
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery
Official Title
Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage Postpartum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol oral tablets
Arm Type
Active Comparator
Arm Description
79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping
Arm Title
Ranitidine oral tablets
Arm Type
Placebo Comparator
Arm Description
79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping
Intervention Type
Drug
Intervention Name(s)
Misoprostol Oral Tablet
Other Intervention Name(s)
Misotac
Intervention Description
at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
Intervention Type
Drug
Intervention Name(s)
Ranitidine Oral Tablet
Other Intervention Name(s)
Ranitak
Intervention Description
at cord clamping the patient will recieve ranitidine sublingually
Primary Outcome Measure Information:
Title
Blood loss during cesarean sections
Description
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
Secondary Outcome Measure Information:
Title
Vaginal bleeding
Description
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
Title
Change in blood pressure and pulse
Description
Change in blood pressure and pulse before and after the cesarean section
Time Frame
through study completion, an average of 1 year
Title
Blood loss after 24 hr.
Description
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
Title
Need for additional uterotonic agent
Description
Need for additional uterotonic agent e.g oxytocin - methyl ergotamine
Time Frame
through study completion, an average of 1 year
Title
Need for blood transfusion
Description
number of patients receiving blood transfusion
Time Frame
through study completion, an average of 1 year
Title
Need for surgical measures to stop bleeding
Description
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
Title
Side effects of misoprostol
Description
Nausea, Vomiting or Diarrhea
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed H Fathy, M.B.B.Ch
Phone
00201099984100
Email
Mohamedfathy31085@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr YEHIA, MD,MRCOG
Phone
00201227900014
Email
am_helmy77@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr H YEHIA, MD,MRCOG
Organizational Affiliation
Ain Shams University-Maternity Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ain shams maternity hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Fathy, M.B.B.Ch
Phone
00201099984100
Email
Mohamedfathy31085@gmail.com
First Name & Middle Initial & Last Name & Degree
AMR Helmy, MD.MRCOG
Phone
00201227900014
Email
am_helmy77@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

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