Delayed Umbilical Cord Clamping - C-section Pilot
Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
California
-
Sacramento, California, Verenigde Staten, 95817
- University of California Davis Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
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
|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
maternal estimated blood loss (EBL)
Tijdsspanne: at delivery (approximately 1 hour duration)
|
Excessive EBL will be assessed by three measures
|
at delivery (approximately 1 hour duration)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
neonatal hypothermia
Tijdsspanne: at admission (within 30 minutes of birth)
|
moderate or severe neonatal hypothermia (36.2 rectal or less)
|
at admission (within 30 minutes of birth)
|
|
newborn hemoglobin concentration and hematocrit
Tijdsspanne: first day of life (0-24 h of age)
|
mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)
|
first day of life (0-24 h of age)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
phototherapy
Tijdsspanne: < 14 days of age
|
phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life
|
< 14 days of age
|
|
Neonatal intensive care (NICU) 'observation' or admission
Tijdsspanne: birth hospitalization (first 72 h of age approximately)
|
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.
|
birth hospitalization (first 72 h of age approximately)
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 400656-4
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Cesarean Sections
-
Ankara City Hospital BilkentWervingKeizersnede | Klinische resultaten | Myometriale dikte | Sluiting van het keizersnede litteken | Cesarean littekendefect (Isthmocoele) | PostpartumcomplicatiesTurkije (Türkiye)
-
Hédi Chaker HospitalVoltooidBekkenpijn | Metrorragie | Amenorroe secundair | Spotten | Cesarean littekendefect (Isthmocoele)Tunesië