Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial

NCT ID: NCT01655576

Last Updated: 2013-06-05

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

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.

Detailed Description

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The study aims to compare the effectiveness of placental drainage versus maintenance of maternal cord clamped end in the third stage of labor to reduce postpartum blood loss.

Conditions

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Management of Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Routine clamping

After delivery of the newborn, umbilical cord at mothers end, will be left clamped until delivery of the placenta.

Group Type NO_INTERVENTION

No interventions assigned to this group

Placental drainage

After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.

Group Type EXPERIMENTAL

Placental drainage

Intervention Type PROCEDURE

After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.

Interventions

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Placental drainage

After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Low risk pregnant women
* Pregnancy at term
* Women at low risk for assisted labor / delivery and postpartum care.
* Live Fetus

Exclusion Criteria

* Women under 18, mentally handicapped and indigenous;
* Women who agreed to participate signed the Informed Consent, but evolved to cesarean section or instrumental delivery by forceps;
* Instrumental Delivery by forceps or c-section
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role lead

Responsible Party

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Leila Katz

MD pHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IMIP

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

References

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Vasconcelos FB, Katz L, Coutinho I, Lins VL, de Amorim MM. Placental cord drainage in the third stage of labor: Randomized clinical trial. PLoS One. 2018 May 2;13(5):e0195650. doi: 10.1371/journal.pone.0195650. eCollection 2018.

Reference Type DERIVED
PMID: 29718920 (View on PubMed)

Other Identifiers

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Pla1

Identifier Type: REGISTRY

Identifier Source: secondary_id

PLADRAINAGE

Identifier Type: -

Identifier Source: org_study_id

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