NCT02659605

Brief Summary

The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
5 years until next milestone

Results Posted

Study results publicly available

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

January 15, 2016

Results QC Date

February 7, 2018

Last Update Submit

January 31, 2022

Conditions

Pre-term BirthDelayed Cord Clamping

Keywords

pre-term birthdelayed cord clampingskin to skin

Outcome Measures

Primary Outcomes (1)

  • Hematocrit Level

    24 hours after delivery

Secondary Outcomes (5)

  • Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)

    during the initial hospital stay (1-2 days)

  • Number of Participants With Infants Who Received Phototherapy

    during the initial hospital stay (1-2 days)

  • Number of Participants With Infants Who Received Blood Transfusion

    during the initial hospital stay (1-2 days)

  • Apgar Score at 1 Minute

    1 minute after birth

  • Apgar Score at 5 Minutes

    5 minutes after birth

Study Arms (2)

Delayed cord clamping above the perineum

EXPERIMENTAL
Procedure: Delayed cord clamping above the perineum

Delayed cord clamping below the perineum

ACTIVE COMPARATOR
Procedure: Delayed cord clamping below the perineum

Interventions

Delayed cord clamping above the perineumPROCEDURE

After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.

Delayed cord clamping above the perineum
Delayed cord clamping below the perineumPROCEDURE

The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.

Delayed cord clamping below the perineum

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation

You may not qualify if:

  • Acute febrile illnesses or chronic medical problems such as hypertension, diabetes mellitus, renal disease, medically-managed seizure disorders
  • Pregnancy-related complications such as pre-eclampsia, intrauterine growth restriction, chromosomal/anatomical abnormalities, and placental abruption
  • Infants who are not anticipated to undergo spontaneous vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Mansaray A, Yetman R, Berens P. Effect of Delayed Cord Clamping Above Versus Below the Perineum on Neonatal Hematocrit: A Randomized Controlled Trial. Breastfeed Med. 2015 Dec;10(10):464-7. doi: 10.1089/bfm.2015.0109.

    PMID: 26651542BACKGROUND

Limitations and Caveats

Inability to blind participants and medical staff involved in the delivery. Data for some subjects was not obtained due to systems errors.

Results Point of Contact

Title
Dr. Pamela D. Berens
Organization
The University of Texas Health Science Center at Houston
Pamela.D.Berens@uth.tmc.edu
(713) 500-6471

Study Officials

  • Pamela Berens, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 2, 2022

Results First Posted

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)