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

March 7, 2014 updated by: Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • ŞiŞLİ
      • İstanbul, ŞiŞLİ, Turkey, 32744
        • Osman Aşıcıoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postpartum blood loss
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Investigators

  • Principal Investigator: Osman Aşıcıoğlu, M.D., T.C.S.B. Şişli Etfal Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aşıcıoğlu-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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