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

Primary Purpose

Postpartum Haemorrhage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Placental cord drainage
Sponsored by
Istanbul Bakirkoy Maternity and Children Diseases Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Haemorrhage

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Osman Aşıcıoğlu

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

No Intervention

Arm Label

Drainage Group

Controlled Group

Arm Description

early placental drainage plus cord traction

spontaneous removal placenta

Outcomes

Primary Outcome Measures

postpartum blood loss

Secondary Outcome Measures

Full Information

First Posted
August 26, 2013
Last Updated
March 7, 2014
Sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01931423
Brief Title
The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Haemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drainage Group
Arm Type
Placebo Comparator
Arm Description
early placental drainage plus cord traction
Arm Title
Controlled Group
Arm Type
No Intervention
Arm Description
spontaneous removal placenta
Intervention Type
Behavioral
Intervention Name(s)
Placental cord drainage
Primary Outcome Measure Information:
Title
postpartum blood loss
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: greater than 37 gestational weeks single pregnancy vaginal delivery estimated fetal weight 2500-4500 gr. Exclusion Criteria: PPROM 37 or lower gestational week multiple pregnancy grand multiparıty (greater than 5) coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia) a history of any bleeding during pregnancy caesarean delivery or any uterine scar a history of postpartum haemorrhage hydramnios known uterine anomalies suspected abnormal placentation (accreta, increta, or percreta) prepartum hemoglobin concentration less than 8 g/dL history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osman Aşıcıoğlu, M.D.
Organizational Affiliation
T.C.S.B. Şişli Etfal Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osman Aşıcıoğlu
City
İstanbul
State/Province
ŞiŞLİ
ZIP/Postal Code
32744
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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