Study design
We conducted a quality improvement cohort QI study of cord clamping practice in assisted vaginal deliveries. The study consisted of two phases: A baseline 8-month period (Period 1), where standard care was applied (March 1st to October 31st 2017), followed by an 8-month intervention-period (Period 2), where the new protocol and resuscitation equipment were implemented (November 1st 2017 to June 30th 2018). We used anonymous data from the previously described Patient Safety and Quality Improvement Project. The study was approved as a service evaluation as defined by the Regional Committee for Medical and Health Research Ethics (2018/1755/REK midt), and waiver of individual patient informed consent was granted. It was approved by the Director of Clinic for Women, Children and Adolescents, Møre and Romsdal Hospital Trust, and by the institution’s Privacy Ombudsman (ephorte reference 2018/1357–10).
Setting
The study was performed at Clinic for Women, Children and Adolescents, Møre and Romsdal Hospital Trust, Ålesund, Norway. At this clinic, low-risk deliveries are midwife-led, whereas complicated deliveries are led by teams consisting of an obstetrician, an obstetric registrar and a midwife. A Neonatal Intensive Care Unit (NICU) facilitates care for sick and premature infants. Whenever possible, the collaborative conduct of assisted vaginal deliveries is planned prior to delivery with a paediatric team (paediatric registrar and neonatal intensive care nurse), expected to be present in the delivery room and responsible for initial assessment and treatment of the infant. An evidence based protocol of delayed cord clamping was introduced in 2009.
Standard care (Period 1)
Risk assessments and differentiation of care were guided by national clinical standards, and done during pregnancy, at patient admission and during labour. Preparations in the delivery room were done accordingly. Paediatric team was alarmed when breech birth was imminent, or decision of instrumentation was made. A resuscitation table (Cosy-Cot™, Fisher & Paykel Healthcare, Auckland, NZ) was brought into the room and placed opposite to the birthing bed.
Delayed cord clamping was attempted in all deliveries, while providing essential care. An assistant midwife obtained arterial and venous cord blood gases from a pulsating cord within the first 30–40 s. Apgar Scores were evaluated after 1, 5 and 10 min by the paediatric team. Neonatal resuscitation algorithm was applied [33].
If the infant was compromised and not recovering during the first 30–60 s, the umbilical cord was cut at least 30 cm from the umbilicus, and the infant was moved to the resuscitation table for further assessment and care. Cord clamping time was recorded by an assistant nurse, using a digital clock in the delivery room. If the infant did not respond to initial stimulation, umbilical cord milking (UCM) 3–5 times towards the umbilicus was recommended to expedite placental transfusion, or as a substitute for DCC. Preheated linen and an overhead warmer protected the infant from hypothermia. Ventilation support was provided with a T-piece resuscitator (NeoPuff Infant Resuscitator™, Fisher & Paykel, Auckland, NZ). Suction equipment (AGA MS-33 Suction EjectorTM, AGA – Linde Healthcare, Oslo, Norway) was applied if necessary. Ventilation support was initiated with room air, controlled by a gas flowmeter (Low-flow Air-Oxygen Blender™, Ohio Medical Corporation, Gurnee, US). Oxygen fraction was increased according to protocol. Pulse oximetry (Nellcor™ OxiMax N-65, Covidien, Boulder CO, US) was recommended. Once stabilized, infants were placed skin-to-skin on the mother’s chest and covered.
New delivery-room protocol (Period 2)
Preparations, initial assessment and care were provided as described for period 1. In addition, a mobile resuscitation trolley, LifeStart™ (Inspiration Health Care Ltd. Leicestershire, UK) was placed next to the birthing bed. The trolley was tubed to central supplies of air and oxygen, and fully equipped with a T-piece resuscitator, Oxi-blender and suction equipment to facilitate bed-side transitional support and resuscitation. A heating mattress, Cosy-Therm™ (Inspiration Health Care Ltd. Leicestershire, UK) was used for prevention of hypothermia.
Equipment for assisted vaginal delivery was set up on the opposite side of the birthing bed to avoid logistic problems. If non-vigorous immediately after birth, infants were placed on LifeStart™ for drying, stimulation and further assessment. The algorithm for resuscitation of the newborn by the Norwegian Resuscitation Council (NRR) was applied [33], and modified to include transitional support with intact umbilical cord (Fig. 1). UCM was recommended as described for Period 1. Any ventilation support or resuscitation was initiated with intact umbilical cord. Surveillance by pulse oximetry was recommended. Self-breathing and crying infants were placed directly on mothers’ chest. If the umbilical cord was very short, the trolley was placed as close to the mother’s vagina as possible, otherwise the trolley was placed perpendicular to the birthing bed.
The umbilical cord was cut no earlier than one minute after delivery of the infant; preferably after cease of pulsations or when the cord had turned white. Cord clamping time was recorded. In the event of obstetric emergency requiring better access to the mother, plans were made for how to move the paediatric team quickly. Once stabilized and self-breathing, the infants were placed skin-to-skin with their mothers and covered.
Inclusion
Live-born singletons with gestational age (GA) ranging from 36 + 0 to 43 + 0 weeks, subject to assisted vaginal delivery (ventouse, forceps or breech), born in the delivery unit during periods 1 and 2 were eligible for inclusion in the QI-project. Vaginal twin deliveries and any converts to emergency caesarean section were excluded.
Data collection
Data was collected for all consecutive births meeting inclusion criteria. Electronic birth records lacked data on cord clamping; hence data was collected manually for the QI-project. A paper-based form was already routinely in use; collecting data like exact time of birth, birthweight, Apgar scores; serving as support for the subsequent electronic documentation. It was modified to include data on parity, gestational age, delivery mode, indications for assisted delivery and intact cord blood gases. In cases of ECC, attending midwives were asked to fill in indication and whether the cord was milked or not.
For the QI-project, relevant data was registered in an Excel spread-sheet. Once registered, forms were shredded. Data from all deliveries meeting inclusion criteria was extracted from the QI-project data-file and prepared for this study by the QI-project leader. Data on adverse events were extracted from the hospital’s incident reporting system.
Primary outcome
Prevalence of early cord clamping (ECC)
Secondary outcomes
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Apgar score at 1,5 and 10 min after birth
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Placement of the infant the first minute after birth (resuscitation table or mother’s chest
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Immediate care of the infant (stimulation/drying, heat-loss prevention, pulse-oximetry)
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Rectal temperature at 10–20 min
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Need for ventilation support
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Need for full resuscitation (chest compressions and positive pressure inflation)
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Transfer to NICU (birth-related reasons).
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Adverse events
Study of the intervention
The Model for Improvement by Langley [34] was applied in both study periods, representing a theoretical and practical framework for the QI-project. The model’s major tenets are: Setting time-specific and measureable aims, establishing measures to determine if a specific change leads to an improvement, selecting changes that will result in improvement and testing the changes by conducting Plan-Do-Study-Act (PDSA) cycles in a real work setting.
After baseline testing of adherence to cord clamping protocol, an operational target of maximum 2% ECC in vaginal deliveries by November 1st, 2017 was set by the QI-project team. Starting in March, 2017, several PDSA-cycles were carried out to support the improvement efforts.
Identification of drivers and obstacles revealed a gap of knowledge about the benefits of DCC and support of transition with an intact umbilical cord. Thus, building a common knowledge base through cross-professional educational sessions was prioritized. Repeated 1-h standardized presentations of the theoretical rationale was directed by the QI-project team (midwife, neonatologist and NICU-nurse). Cross-professional participation was encouraged to broaden perspectives in plenum discussions. Clinical and practical questions were welcomed and addressed.
Prior to implementation of the new protocol and equipment, mandatory training for all involved personnel was seen as essential to reduce the chances of technical and operational failure or adverse events at the set-out. Training included 1-h theoretical and practical demonstration of set-up and operation of LifeStart™ and associated resuscitation equipment, followed by 2-h simulation training in situ. Simulation included debriefing focusing on inter-disciplinary collaboration and communication. During this preparation, the new delivery room protocol was adjusted according to continuous feedback from discussions and inter-disciplinary hearings.
After implementing the new protocol and equipment, re-education to all involved personnel was offered at several occasions, including brief lectures in the delivery unit and NICU, posters and short simulation sessions. Continuous feedback was welcomed, in order to rule out deviations such as procedural misunderstandings, user errors and technical difficulties. The protocol was again modified, and involved personnel updated, accordingly.
To establish whether the observed outcomes were due to implementation of the new protocol and equipment, or were already detectable before this, variation in cord clamping time was monitored during both study periods, using Statistical Process Control (SPC) analyses [35]. Run charts were used to demonstrate signals of improvement, and whether changes lead to improvement over time. Performance was displayed on an Improvement Board in the delivery unit, for transparency and motivation.
Statistical analyses
IBM SPSS Statistics software, version 23 was applied for all statistical analysis. P-values less than 0.05 were considered to indicate statistical significance. Univariate analyses were performed to identify differences in background variables and cord clamping variables between periods 1 and 2. Continuous variables were compared by using the Mann-Whitney U test or Student’s t-test as appropriate. Categorical / dichotomous variables were compared by using Pearson’s Chi-square (x2) test or Fischer’s exact test as appropriate.
Multivariate logistic regression analysis was used to assess the impact of the new delivery room protocol on the prevalence of early cord clamping, adjusted for possible confounding factors. Unadjusted and adjusted odds ratios (OR) were presented with 95% confidence intervals (CI).
The Run Chart was created using Microsoft Excel and analysed using the median and standard run chart evaluation rules. According to the user manual [36], a “shift” represents a period where six or more consecutive points all fall above or below the median, whereas a “trend” occurs when five or more consecutive points all rise or fall.