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

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. Identifier: NCT01931410
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital

Brief Summary:
The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.

Condition or disease Intervention/treatment Phase
ıntrapartum Haemorrhage Postpartum Haemorrhage Drug: Misoprostol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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)

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 identifier (NCT number): NCT01931410

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

Responsible Party: Osman Aşıcıoğlu, M.D. Obstetric and Gynecology, Istanbul Bakirkoy Maternity and Children Diseases Hospital Identifier: NCT01931410     History of Changes
Other Study ID Numbers: Aşıcıoğlu-05
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

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