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The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study

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ClinicalTrials.gov Identifier: NCT01931423
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital

Brief Summary:
To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.

Condition or disease Intervention/treatment
Postpartum Haemorrhage Behavioral: Placental cord drainage

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : November 2013
Primary Completion Date : February 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Drainage Group
early placental drainage plus cord traction
Behavioral: Placental cord drainage
No Intervention: Controlled Group
spontaneous removal placenta



Primary Outcome Measures :
  1. postpartum blood loss [ Time Frame: 24 hours ]


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. greater than 37 gestational weeks
  2. single pregnancy
  3. vaginal delivery
  4. estimated fetal weight 2500-4500 gr.

Exclusion Criteria:

  1. PPROM
  2. 37 or lower gestational week
  3. multiple pregnancy
  4. grand multiparıty (greater than 5)
  5. coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia)
  6. a history of any bleeding during pregnancy
  7. caesarean delivery or any uterine scar
  8. a history of postpartum haemorrhage
  9. hydramnios
  10. known uterine anomalies
  11. suspected abnormal placentation (accreta, increta, or percreta)
  12. prepartum hemoglobin concentration less than 8 g/dL
  13. history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours

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): NCT01931423


Locations
Turkey
Osman Aşıcıoğlu
İstanbul, ŞiŞLİ, Turkey, 32744
Sponsors and Collaborators
Istanbul Bakirkoy Maternity and Children Diseases Hospital
Investigators
Principal Investigator: Osman Aşıcıoğlu, M.D. T.C.S.B. Şişli Etfal Research Hospital

Responsible Party: Osman Aşıcıoğlu, M.D. Obstetric and Gynecology, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier: NCT01931423     History of Changes
Other Study ID Numbers: Aşıcıoğlu-06
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: November 2013

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage