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The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

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ClinicalTrials.gov Identifier: NCT03680339
Recruitment Status : Not yet recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

  • Intaoperative blood loss
  • Risk of Postpartum hemorraghe in the first 24 hrs
  • HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit


Condition or disease Intervention/treatment Phase
Post Partum Hemorrhage Procedure: cesarean section Drug: Misoprostol Drug: Oxytocin Phase 4

Detailed Description:

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

  • Intaoperative blood loss
  • Risk of Postpartum hemorraghe in the first 24 hrs
  • HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Routine ecbolic group
100 patients will receive routine ecbolics ( oxytocin) after delivery of baby
Procedure: cesarean section
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers

Drug: Oxytocin
10 IU of oxytocin with fetal delivery

Active Comparator: Misoprostol group
The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Procedure: cesarean section
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers

Drug: Misoprostol
The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Other Name: Cytotec

Drug: Oxytocin
10 IU of oxytocin with fetal delivery




Primary Outcome Measures :
  1. postpartum hemorrhage [ Time Frame: 24 hours after cesarean section ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

women attending for elective CS.

  • Age between 20-35 years.
  • Normal placental site
  • Normal coagulation profile
  • Full term pregnancies(above 37 wks)
  • Medically free
  • Spinal anesthesia
  • Living baby
  • Average liquor by U/S

Exclusion Criteria:

  • • Women attending for emergency CS

    • .age below 20 or above 35
    • Abnormal placentation (Placenta previa,accrete,increta or percreta)
    • Women with coagulopathy
    • Preterm pregnancies (before 37 wks)
    • Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
    • General anathesia
    • IUFD
    • Oligo or polyhydraminos by U/S

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680339


Contacts
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Contact: Ahmed maged, MD +2001005227404 prof.ahmedmaged@gmail.com
Contact: Mohamed Shalaby, MD mohamed_shalaby85@hotmail.com

Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12111
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed maged, MD Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03680339     History of Changes
Other Study ID Numbers: 42
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents