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Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

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ClinicalTrials.gov Identifier: NCT02083107
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : June 27, 2014
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

Brief Summary:
The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: sublingual misoprostol & rectal placebo
will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".
Drug: Misoprostol
Comparison of different routes of administration of 400 micro gram misoprostol
Other Names:
  • Misotac
  • Cytotec

Placebo Comparator: rectal & sublingual placebo
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
Other: Placebo
Experimental: rectal misoprostol & sublingual placebo
will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".
Drug: Misoprostol
Comparison of different routes of administration of 400 micro gram misoprostol
Other Names:
  • Misotac
  • Cytotec




Primary Outcome Measures :
  1. Intraoperative Blood Loss [ Time Frame: from start of cesarean section till the end of operation (average one hour) ]

Secondary Outcome Measures :
  1. Need for Extra Ecbolics (Oxytocin). [ Time Frame: from start of cesarean section till the end of operation (average one hour) ]
  2. APGAR Score [ Time Frame: 1minute and 5 minutes from delivery of the fetus ]
    The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).

  3. Time to Resume Bowel Habits [ Time Frame: average 24 hours ]
  4. Need for Extra Analgesics [ Time Frame: average 24 hours ]
  5. Need for Postoperative Blood Transfusion [ Time Frame: average 24 hours ]
  6. Incidence of Wound Sepsis [ Time Frame: upto one week ]
  7. Incidence of Adverse Effects [ Time Frame: 24 hours ]

Other Outcome Measures:
  1. Change in Hemoglobin Concentration [ Time Frame: 24 hours postoperative from baseline hemoglobin ]
  2. Change in Hematocrite Value [ Time Frame: 24 hours postoperative from baseline hematocrite value ]


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients booked for elective cesarean section.
  2. Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section

Exclusion Criteria:

  1. Primigravida.
  2. Blood dyscrasias.
  3. Large fibroids.
  4. Multiple pregnancies.
  5. Overdistended uterus eg. Hydramnios.
  6. Pre-eclampsia.
  7. Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
  8. Previous history of PPH.
  9. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
  10. Placenta previa.
  11. Contraindication to spinal anesthesia.
  12. Previous myomectomy.
  13. Previous two or more C.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): NCT02083107


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohamed S. Sweed, MD Ain Shams University
Study Director: Mourad M. El-Said, Professor AinShams University
Study Director: Amgad E. Abou-Gamrah, Ass.Prof. AinShams university
Study Director: Haitham El-Sabe, MD AinShams University
Principal Investigator: Mohamed M. AbdEl-Hamid, Registrar AinShams University
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Responsible Party: Mohamed S Sweed, MD, Mohamed S. Sweed, Lecturer of Obstetrics &Gynecology, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02083107    
Other Study ID Numbers: 9021344
First Posted: March 11, 2014    Key Record Dates
Results First Posted: June 27, 2014
Last Update Posted: December 22, 2015
Last Verified: November 2015
Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
Postpartum hemorrhage
Intrapartum blood loss
Misoprostol
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Postoperative Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics