Delayed Umbilical Cord Clamping - C-section Pilot
Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord clamping remains a common obstetrical practice. The World Health Organization has noted that data on cesarean deliveries are more limited, particularly with respect to long-term effects in infants. Recently, the American College of Obstetrics and Gynecology also noted in a committee statement that " the ideal time for clamping of the umbilical cord in cesarean section vs. vaginal birth is a particularly important area for future research".
The objective of this study is to conduct a pilot trial of delayed cord clamping during cesarean deliveries to determine if progressively longer intervals of cord clamping are feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes from historical controls. We will offer study entry for women planning elective cesarean delivery to collect prospective data on progressively longer intervals, analyzing outcomes for each time interval to ensure they are clinically acceptable, prior to extending the interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec) and will perform hemoglobin analysis on the infants specifically for this study. If intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the cord will be clamped.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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California
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Sacramento, California, Vereinigte Staaten, 95817
- University of California Davis Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:Subjects that are pregnant (women 18 years of age and older) and scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the study.
Exclusion Criteria:
Pregnant women that do not plan on having a C-section and individuals that are not pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth retardation will be excluded. Adults unable to consent will not be included
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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90 seconds DCC
the initial 15-20 subjects (15 enrolled subjects who complete study) will have cord clamped at 90 seconds.
Then data will be analyzed and evaluated by DSMB
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Two minutes DCC
If Data Safety Monitoring Board (DSMB) concurs, DCC will then be practiced for 2 minutes for second group, which is the minimum amount of time recommended to be defined as DCC.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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maternal estimated blood loss (EBL)
Zeitfenster: at delivery (approximately 1 hour duration)
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Excessive EBL will be assessed by three measures
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at delivery (approximately 1 hour duration)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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neonatal hypothermia
Zeitfenster: at admission (within 30 minutes of birth)
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moderate or severe neonatal hypothermia (36.2 rectal or less)
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at admission (within 30 minutes of birth)
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newborn hemoglobin concentration and hematocrit
Zeitfenster: first day of life (0-24 h of age)
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mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)
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first day of life (0-24 h of age)
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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phototherapy
Zeitfenster: < 14 days of age
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phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life
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< 14 days of age
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Neonatal intensive care (NICU) 'observation' or admission
Zeitfenster: birth hospitalization (first 72 h of age approximately)
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NICU 'observation' during transition or admission will be measured and reason for admission.
respiratory symptoms are most of interest, but historical controls will only have data yes/no so we will look at overall nicu admissions also.
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birth hospitalization (first 72 h of age approximately)
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 400656-4
Plan für individuelle Teilnehmerdaten (IPD)
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Klinische Studien zur Cesarean Sections
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