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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01931423
First Posted: August 29, 2013
Last Update Posted: March 10, 2014
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
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 Intervention
Postpartum Haemorrhage Behavioral: Placental cord drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 blood loss [ Time Frame: 24 hours ]

Enrollment: 485
Study Start Date: November 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Drainage Group
early placental drainage plus cord traction
Behavioral: Placental cord drainage
No Intervention: Controlled Group
spontaneous removal placenta

  Eligibility

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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
  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): 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
  More Information

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 Submitted: August 26, 2013
First Posted: August 29, 2013
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