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

NCT ID: NCT01931423

Last Updated: 2014-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Postpartum Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Drainage Group

early placental drainage plus cord traction

Group Type PLACEBO_COMPARATOR

Placental cord drainage

Intervention Type BEHAVIORAL

Controlled Group

spontaneous removal placenta

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Placental cord drainage

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Bakirkoy Maternity and Children Diseases Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Osman Aşıcıoğlu

M.D. Obstetric and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osman Aşıcıoğlu, M.D.

Role: PRINCIPAL_INVESTIGATOR

T.C.S.B. Şişli Etfal Research Hospital

Locations

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Osman Aşıcıoğlu

Istanbul, ŞiŞLİ, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Aşıcıoğlu-06

Identifier Type: -

Identifier Source: org_study_id

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