This study will evaluate if neonatal effects as described in previous studies are seen in delayed umbilical cord clamping in caesarean sections. Moreover, we will review the maternal effects compared to conventional cord milking in caesarean…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcomes will be divided in primary and secondary outcomes. Main infant study
outcomes will be 1) Haemoglobin and haematocrit concentrations 48 hours after
birth, 2) APGAR score and 3) Rectal temperature.
Secondary outcome
Secondary outcomes will be divided into maternal outcomes and outcome of
infants.
Maternal outcomes:
1. Maternal blood loss during caesarean section.
2. Need for maternal blood transfusion.
3. Maternal infections in the postnatal period (6 weeks period)
Infant outcomes:
1. Complete serum bilirubin value 2 days after birth
2. Ferritin and Hemoglobin values at the age of 4 months
Background summary
Multiple previous studies show a significant association between delayed
umbilical cord clamping and improved post-partum transition for the infants.
Especially previous studies showed increased early haemoglobin concentrations
and iron stores in infants. Despite the widespread implication of delayed
umbilical cord clamping (DUCC) in the Dutch midwife practice and Dutch
hospitals, previous studies only show small percentage of use of DUCC in
caesarean sections. The available research regarding delayed umbilical cord
clamping during caesarean section is limited. However, these studies assessed
the parameters with a small group of patients. Therefore, the evidence for DUCC
in caesarean sections is scarce. We aimed to study the neonatal and maternal
effects with DUCC in caesarean sections compared to early umbilical cord
clamping (cord milking).
Study objective
This study will evaluate if neonatal effects as described in previous studies
are seen in delayed umbilical cord clamping in caesarean sections. Moreover, we
will review the maternal effects compared to conventional cord milking in
caesarean sections.
Study design
This study will be organised as a randomised prospective cohort study in a
secondary referral clinical (Amphia Hospital Molengracht, Breda).
Intervention
There will be a randomisation in two groups for the complete study population
of approximately 100 study objects. Randomisation will be 1) Cord milking and
2) Delayed umbilical cord milking.
Study burden and risks
This study required additional blood examination of infants in the first days
of life. In total, two additional blood examinations will complete this study.
Further additional research is not necessary. No burden or adverse events will
be associated with participation. If the maternal of infants condition is
inadequate to participate in this study, standard practice will be used (cord
milking). Because of potential risks in a vulnerable study population this
study will be supervised by a DSMB. This board will monitor the risks and
benefits of this study and if necessary will adjust the protocol of the study.
A neonatologist, gynaecologist and epidemiologist will participate in this
board. Meetings and agreements are available in this study protocol and in the
DSMB-charter.
Molengracht 21
Breda 4818CK
NL
Molengracht 21
Breda 4818CK
NL
Listed location countries
Age
Inclusion criteria
- Primary cesarean section
- Duration of pregnance between 37 and 42 weeks
Exclusion criteria
- Secundary cesarean section
- Maternal clotting disorder
- Maternal irregular antibodies
- Maternal fever
- Prelabor rupture of the membranes (PROM) > 24 hours
- Caesarean section indicated because of placenta praevia
- Caesarean section performed under general anesthesia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65977.100.18 |