WithdrawnNot Applicable

Timing of Cord Clamping and Neonatal Hemoglobin

Stopped: PI left university

United States0Started 2006-09

Plain-language summary

The purpose of this study is to determine whether the timing of the clamping of the umbilical cord after delivery has an impact on neonatal hemoglobin and hematocrit, tests that determine the number of red cells in the blood and their ability to carry oxygen. The study hypothesis is that delaying cord clamping until cord pulsation has ceased will increase the neonatal blood volume and thereby increase the hemoglobin and hematocrit. We propose to recruit 150 women who present for vaginal delivery at Tulsa Regional Medical Center. Half of the women will be randomly assigned to the immediate clamping group, which will entail clamping of the umbilical cord within six seconds of delivery of the fetal shoulders. The other half of the volunteers will be assigned to the delayed clamping group, which will entail clamping the cord after a palpable pulse has ceased, or after 10 minutes. The infants of mothers in both groups will have blood drawn for a hemoglobin and hematocrit at the time of the routine PKU heel stick, usually is performed within 18-24 hours of delivery. Statistical differences between the blood counts of infants in the control and study groups will be compared using independent samples t tests.

Who can participate

Age range

18 Years – 34 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy women and their newborn infants delivered at Tulsa Regional Medical Center, * between the ages of 18 and 34, * full term (37 to 41 weeks), * singleton pregnancy at the time of delivery Exclusion Criteria: * Delivery complicated by non-reassuring fetal heart tones, * preeclampsia, * eclampsia, * chronic hypertension, * meconium-stained amniotic fluid, * fetal anomalies or * any other condition which could require immediate newborn evaluation by nursery personnel at the time of delivery. Infants requiring operative delivery by forceps or vacuum also will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

hemoglobin

Timeframe: day of birth

Trial details

NCT IDNCT00371228

SponsorOklahoma State University Center for Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Anemia trials