The Influence of Placental Drainage of Management of the... | NCT01931423

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

NCT01931423

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Status

Completed

Last Update Posted

Mar 10, 2014Estimated

Enrollment

485Actual

Phase

Not Applicable

Conditions

Postpartum Haemorrhage

Interventions

Placental cord drainage

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Aug 26, 2013

First Submission Date that Met QC Criteria

Aug 26, 2013

First Posted Date

Aug 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2014

Last Update Posted Date

Mar 10, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osman Aşıcıoğlu, M.D. Obstetric and Gynecology, Istanbul Bakirkoy Maternity and Children Diseases HospitalPrincipal Investigator

Lead Sponsor

Istanbul Bakirkoy Maternity and Children Diseases HospitalOTHER_GOV

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

485Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drainage Group	Placebo Comparator	early placental drainage plus cord traction	Behavioral: Placental cord drainage
Controlled Group	No Intervention	spontaneous removal placenta

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placental cord drainage	Behavioral		Drainage Group

Measure	Description	Time Frame
postpartum blood loss		24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osman Aşıcıoğlu, M.D.	T.C.S.B. Şişli Etfal Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osman Aşıcıoğlu		Istanbul	ŞiŞLİ	32744	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided