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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:
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01931423
First received: August 26, 2013
Last updated: March 7, 2014
Last verified: November 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 44 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 26, 2013
Last Updated: March 7, 2014
Health Authority: Turkey: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014