Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

NCT ID: NCT04353544

Last Updated: 2021-08-24

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

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2021-05-01

Brief Summary

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Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased

Detailed Description

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Conditions

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Post Partum Hemorrhage

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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Immediate cord clamping

Immediate cord clamping was defined as clampingwithin 15 seconds of birth

Group Type ACTIVE_COMPARATOR

delayed cord clamping

Intervention Type OTHER

delayed cord clamping

delayed cord clamping

when the cord stopped pulsing, or five minutes

Group Type EXPERIMENTAL

delayed cord clamping

Intervention Type OTHER

delayed cord clamping

Interventions

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delayed cord clamping

delayed cord clamping

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* at term
* cephalic presentation
* spontaneous labor
* spontaneous vaginal delivery

Exclusion Criteria

* multiple gestation
* preterm gestation
* induced labor
* operative delivery
* hypertension or preeclampsia
* fetal anomaly
* abnormal placentation
* planned cord blood banking
* maternal bleeding disorder
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Casa di Cura Accreditata Fabia Mater, Rome, Italy

UNKNOWN

Sponsor Role collaborator

Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Saccone

principal investigator, medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Casa di Cura Accreditata Fabia Mater, Rome, Italy

Rome, Roma, Italy

Site Status

Countries

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Italy

References

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De Angelis C, Saccone G, Sorichetti E, Alagna M, Zizolfi B, Gragnano E, Legnante A, Sardo ADS. Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial. Int J Gynaecol Obstet. 2022 Dec;159(3):898-902. doi: 10.1002/ijgo.14223. Epub 2022 May 2.

Reference Type DERIVED
PMID: 35428979 (View on PubMed)

Other Identifiers

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1/04-18OST

Identifier Type: -

Identifier Source: org_study_id

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