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:
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01931410
First received: August 26, 2013
Last updated: February 24, 2014
Last verified: February 2014
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 16, 2014