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.
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital Identifier:
First received: August 26, 2013
Last updated: February 24, 2014
Last verified: February 2014
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Postpartum Haemorrhage [ Time Frame: postpartum 24 hour ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 44 Years
Genders 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)
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Please refer to this study by its identifier: 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
  More Information

No publications provided

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
Study First Received: August 26, 2013
Last Updated: February 24, 2014
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Postpartum Hemorrhage
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 27, 2015