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The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01931410
First Posted: August 29, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
  Purpose
The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.

Condition Intervention Phase
ıntrapartum Haemorrhage Postpartum Haemorrhage Drug: Misoprostol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital:

Primary Outcome Measures:
  • Postpartum Haemorrhage [ Time Frame: postpartum 24 hour ]

Enrollment: 618
Study Start Date: June 2013
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sublingual
400 microgram mısoprostol will be administered sublıngually before elective caesarean
Drug: Misoprostol
Placebo Comparator: rectal
rectal 600 mgr misoprostol will be administered
Drug: Misoprostol
No Intervention: synpitan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. live and singleton pregnancy
  2. Elective caesarean
  3. Gestational week greater than 37 weeks
  4. patient between 18-44 year old

Exclusion Criteria:

  1. -multiple pregnancy
  2. Preeclampsia
  3. Gestational diabetes
  4. Macrosomia
  5. Oligohidraamnıos
  6. Polihidraamnıos
  7. Myoma
  8. Morbid obesity
  9. Coagulatıon defect (such as HELLP syndrome)
  Contacts and Locations
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): NCT01931410


Sponsors and Collaborators
Istanbul Bakirkoy Maternity and Children Diseases Hospital
Investigators
Principal Investigator: Berhan AŞICIOĞLU, M.D. T.C.S.B. Kanuni Sultan Süleyman Research Hospital
  More Information

Responsible Party: Osman Aşıcıoğlu, M.D. Obstetric and Gynecology, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier: NCT01931410     History of Changes
Other Study ID Numbers: Aşıcıoğlu-05
First Submitted: August 26, 2013
First Posted: August 29, 2013
Last Update Posted: October 12, 2017
Last Verified: February 2014

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