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OpenTrials
Completed

NCT Number: NCT01766908

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Jackson, Mississippi, 39216, United States

About this study

Intention is to enroll every preterm delivery into this trial containing six groups of patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds. Expectation is 1500 deliveries over 2 year period of time. Randomization upon entry to L&D unit. Removal from study if resuscitation deemed urgent by newborn staff. Strong effort to keep newborn warm using appropriate measures. Evaluation to determine if there are differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of IVH or CP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

multiple gestation/ known intrauterine fetal death unable to sign consent

Treatment and study plan

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

Other

None to add

Other names: Clamping of umbilical cord following either preterm vaginal or cesarean delivery

Primary outcomes

  1. Intraventricular Hemorrhage number and severity

    Time frame: 15 months

    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.

Secondary outcomes

  1. Incidence and volume of red cell transfusion for newborns.

    Time frame: 15 months

    Benefits will be significantly better with very preterm deliveries compared to those delivered from 29-36 weeks gestation. These benefits will include a lower incidence of transfusion and less frequent/less severe intraventricular hemorrhage in new borns.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth

Acronym: CordClamp

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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