Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery

NCT01766908 | Completed

• 1 other identifier: 2011-0270
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. This study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. Benefit to the baby may come by increasing the amount of blood in the baby's body, reducing the need for possible transfusion later, and possible prevention of other complications caused by too little blood in the baby. Possible reduction of cerebral palsy may be realized by a longer interval for cord clamping.

Conditions

Preterm Birth

Keywords

Timing of Umbilical Cord clamping; Cord Clamp 20 seconds; Cord Clamp 40 seconds; Cord Clamp 60 seconds

Outcome Measures

Primary Outcomes (1)

• Intraventricular Hemorrhage number and severity

  WE are seeking the length of time to delay cord clamping for various gestational age groups following vaginal or cesarean delivery in order to significantly improve primary outcome.

  15 months

Secondary Outcomes (1)

• Incidence and volume of red cell transfusion for newborns.

  15 months

Study Arms (3)

Cord Clamp 20 Seconds After Delivery

ACTIVE COMPARATOR

Intervention is cord clamp at 20 seconds following vaginal or cesarean delivery

Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

Cord Clamp 40 seconds After Delivery

ACTIVE COMPARATOR

Timing of cord clamp at 40 seconds following vaginal or cesarean delivery.

Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

Cord Clamp 60 seconds After Delivery

ACTIVE COMPARATOR

Intervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery

Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

Interventions

Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery OTHER

None to add

Also known as: Clamping of umbilical cord following either preterm vaginal or cesarean delivery

Cord Clamp 20 Seconds After Delivery; Cord Clamp 40 seconds After Delivery; Cord Clamp 60 seconds After Delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old singleton gestation Between 23-37 weeks gestation Able to understand and sign informed consent

You may not qualify if:

• multiple gestation/ known intrauterine fetal death unable to sign consent

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• James Martin, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 11, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)