# Presentation: 243838

## Quality Care in ObstetricsClinical Bundles

*Peter Cherouny*
*Sue Gullo*
*Institute for Healthcare Improvement*

## The Clinical Bundle

- A group of clinical events that should happen every time a given process occurs

## The Clinical Bundle

*Bundle Components*
- Individual components supported by science
- Required to be performed for every patient, every time
- Bundle compliance measured by fulfilling all parts of the bundle
- Focus on system

## The Clinical Bundle

- All-or-none measurement fosters a system perspective, not parts of the system
- Offers a more sensitive scale for assessing improvements
- The number of measures in the set should be small (perhaps 4 to 8) and each one should measure performance with respect to the specified elements of good care

## Perinatal CommunityBirth Trauma

- Can we reduce birth trauma?
- Estimated that about 50% is potentially avoidable

##  What do we do to babies?
Soft tissue injuries
Nerve injuries
Bone injuries
Neurologic injuries

- Soft tissue injuries
- Nerve injuries
- Bone injuries
- Neurologic injuries

- Perinatal Community*Birth Trauma*

## Quality Care in Obstetrics Birth Trauma

*Causation*
- Large fetuses
- Operative vaginal deliveries (esp midpelvic & combined)
- Vaginal breech delivery
- Inappropriate use of pitocin
- Abnormal/excessive traction
- Inadequate assessment of fetal status

## Quality Care in ObstetricsBirth Trauma

*Prevention*
- Don’t deliver large fetuses
- Don’t do Operative vaginal deliveries
- Don’t do Vaginal breech delivery
- Don’t use pitocin
- Don’t pull too hard
- Interpret fetal status perfectly

## Quality Care in ObstetricsBirth Trauma and Pitocin

*Causation*
- Large fetuses
- Operative vaginal deliveries (esp midpelvic & combined)
- Vaginal breech delivery
- Inappropriate use of pitocin (hyperstimulation)
- Abnormal/excessive traction
- Inadequate assessment of fetal status

## Quality Care in ObstetricsBirth Trauma and Pitocin

*Causation*
- Large fetuses
- Operative vaginal deliveries (esp midpelvic & combined)
- Vaginal breech delivery
- Inappropriate use of pitocin (hyperstimulation)
- Abnormal/excessive traction
- Inadequate assessment of fetal status

## Quality Care in Obstetrics Birth Trauma, Pitocin, OVD

*Causation*
- Large fetuses
- Operative vaginal deliveries (esp midpelvic & combined)
- Vaginal breech delivery
- Inappropriate use of pitocin (hyperstimulation)
- Abnormal/excessive traction
- Inadequate assessment of fetal status

## Quality Care in ObstetricsBirth Trauma, Pitocin, OVD

- Pitocin is involved in over 50% of the situations leading to birth trauma
- Operative Vaginal deliveries have serious complications 5% of the time

## Quality Care in Obstetrics Birth Trauma, Pitocin, OVD

*Prevention of Pitocin Related Trauma*
- Identify large babies
- Don’t do midpelvic deliveries when macrosomia is suspected
- Limit vaginal breech delivery
- Identify and respond to hyperstimulation
- Avoid abnormal/excessive traction
- Interpret fetal monitor by consensus guidelines

## Quality Care in ObstetricsPitocin Use

- Use Pitocin Safely and Effectively
*Know everything about the drug*
*Have established protocols and use them*

## Quality Care in ObstetricsPitocin Use

*Know everything (clinical) about the drug*
- Indications
- Contraindications
- Vasa previa or complete placenta previa
- Transverse fetal lie
- Umbilical cord prolapse
- Previous transfundal uterine surgery
- Nonreassuring fetal assessment

## Quality Care in ObstetricsPitocin Use

_*Not Contraindications but require special attention*_
- Previous low-transverse cesarean delivery
- Breech presentation
- Maternal heart disease
- Multifetal pregnancy
- Polyhydramnios
- Presenting part above the pelvic inlet
- Severe hypertension
- Abnormal fetal heart rate patterns not necessitating emergent delivery

## Quality Care in ObstetricsPitocin Use

_*Requirements for elective labor induction*_
- Assessment of gestational age
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsPitocin Use

_*Requirements for elective labor induction*_
- Assessment of gestational age
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Assessment of gestational age*_
- Confirmation of Term Gestation
- Iatrogenic prematurity is unacceptable and indefensible

## Quality Care in ObstetricsElective Labor Induction-Requirements

_***Confirmation of Term Gestation***_
- Fetal heart tones have been documented for 20 weeks by nonelectronic fetoscope or for 30 weeks by Doppler.
- It has been 36 weeks since a positive serum or urine human chorionic gonadotropin pregnancy test was performed by a reliable laboratory.
- An ultrasound measurement of the crown. rump length, obtained at 6-12 weeks, supports a gestational age of at least 39 weeks.
- An ultrasound obtained at 13-20 weeks confirms the gestational age of at least 39 weeks determined by clinical history and physical examination.
- Amniocentesis and documentation of fetal maturity

## Quality Care in ObstetricsElective Labor Induction-Requirements

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## Quality Care in ObstetricsElective Labor Induction-Requirements

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## Quality Care in ObstetricsElective Labor Induction-Requirements

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## Quality Care in ObstetricsElective Labor Induction-Requirements

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## Quality Care in ObstetricsElective Labor Induction-Requirements

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## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Requirements for elective labor induction*_
- Assessment of gestational age
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Monitoring fetal heart rate for reassurance*_
- Reassuring Fetal Status – use a common language (NICHD)
- Personnel familiar with the effects of uterine stimulants on the fetus
- Physician capable of performing a cesarean delivery should be readily available and responds when asked

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Requirements for elective labor induction*_
- Assessment of gestational age
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*What is Hyperstimulation*_
- > 5 contractions in 10 minutes
- Contractions persistently lasting greater than 2 minutes
- < 60 seconds baseline tone between contractions
- Hypercontractility associated with fetal compromise not necessary

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*What is Hyperstimulation*_
- > 5 contractions in 10 minutes
- Contractions persistently lasting greater than 2 minutes
- < 60 seconds baseline tone between contractions
- Hypercontractility associated with fetal compromise not necessary

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Monitoring uterine contractions for hyperstimulation*_
- Personnel familiar with the effects of uterine stimulants
- Monitoring fetal heart rate and uterine contractions is recommended as for any *high-risk* patient in active labor
- EFM or Intermittent auscultation

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Requirements for elective labor induction*_
- Assessment of gestational age
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Pelvic assessment*_
- Cervical evaluation
- Bishop’s Score
- Fetal presentation and size
- Clinical Pelvimetry

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Requirements for elective labor induction*_
- Assessment of gestational age
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Elective Labor Induction Bundle*_
- Assessment of gestational age
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Elective Labor Induction Bundle*_
- Gestational age _>_ 39 weeks
- Monitoring fetal heart rate for reassurance
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Elective Labor Induction Bundle*_
- Gestational age _>_ 39 weeks
- Reassuring fetal status
- Monitoring uterine contractions for hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Elective Labor Induction Bundle*_
- Gestational age _>_ 39 weeks
- Reassuring fetal status
- Absence of hyperstimulation with increases in pitocin/Response to hyperstimulation
- Pelvic assessment

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Elective Labor Induction Bundle*_
- Gestational age _>_ 39 weeks
- Reassuring fetal status
- Absence of hyperstimulation with increases in pitocin/Response to hyperstimulation
- Pelvic assessment

## Tools Developed for Bundle Success-Example

- Hard stop in booking elective cases- no elective inductions (or elective cesareans) prior to 39 weeks GA.
- Stopped at the booking point
- Prenatal record required on unit prior to booking of any procedure.
- Supported by the Physician Champion and backed up by the OB/GYN Department.

## Quality Care in ObstetricsBirth Trauma

*Causation*
- Large fetuses
- Operative vaginal deliveries (esp midpelvic & combined)
- Vaginal breech delivery
- Inappropriate use of pitocin
- Abnormal/excessive traction
- Inadequate assessment of fetal status

- Inappropriate use of pitocin

## Quality Care in ObstetricsElective Labor Induction-Requirements

_*Elective Labor Induction Bundle*_
- Gestational age _>_ 39 weeks
- Reassuring fetal status
- Absence of hyperstimulation with increases in pitocin/Response to hyperstimulation
- Pelvic Assessment

## Quality Care in ObstetricsAugmentation-Requirements

_*Augmentation Bundle*_
- Gestational age _>_ 39 weeks
- Reassuring fetal status
- Absence of hyperstimulation with increases in pitocin/Response to hyperstimulation
- Pelvic Assessment

## Quality Care in ObstetricsAugmentation-Requirements

_*Augmentation Bundle*_
- Estimated fetal weight
- Reassuring fetal status
- Absence of hyperstimulation with increases in pitocin/Response to hyperstimulation
- Pelvic Assessment

## All or None Measurement

- All-or-none measurement fosters a system perspective, not parts of the system
- Offers a more sensitive scale for assessing improvements
- The number of measures in the set should be small (perhaps 4 to 8) and each one should measure performance with respect to the specified elements of good care

## Quality Care in Obstetrics Birth Trauma

*Causation*
- Large fetuses
- Operative vaginal deliveries (esp midpelvic & combined)
- Vaginal breech delivery
- Inappropriate use of pitocin
- Abnormal/excessive traction
- Inadequate assessment of fetal status

## Quality Care in Obstetrics Birth Trauma

*Causation*
- Large fetuses
- Operative vaginal deliveries
- Vaginal breech delivery
- Inappropriate use of pitocin
- Abnormal/excessive traction
- Inadequate assessment of fetal status

## Quality Care in Obstetrics Birth Trauma

*Causation*
- Operative vaginal deliveries
- Vacuum Assisted deliveries
- Forceps Deliveries

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*What we cause*
- Scalp laceration
- Retinal hemorrhage
- Cephalohematoma
- Subgaleal hemorrhage
- Intracranial hemorrhage
- Hyperbilirubinemia
- Maternal trauma

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Scalp laceration
- From 15-40% neonates have cosmetic scalp trauma
- Related to application time
- Related to improper placement (off midline)
- Rare long term sequelae

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Retinal Hemorrhage
- Approx 38% of Vacuum instrumented infants
- Rare long term sequelae

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Cephalohematoma
- 14-16% of Vacuum instrumented infants
- Hyperbilirubinemia likely results from blood products reabsorbed after cephalohematoma
- Most are benign

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Subgaleal hemorrhage
- 2.6-4.5% of Vacuum instrumented infants
- May be associated with serious long term sequelae and/or death
- Possibly associated with technique

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Intracranial hemorrhage
- May be associated with serious long term sequelae and/or death
- Possibly associated with technique

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Maternal trauma
- Perineal injury
- Hematoma formation
- Possible association with pelvic floor injury

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Conclusion
- Serious complication of Vacuum device in approximately 5% of vacuum attempts
- Patients need to be aware of these risks
- “Given the maternal and fetal risks associated with operative vaginal delivery, it is important that the patient be made aware of the potential complications of the proposed procedure”
*Operative vaginal delivery. ACOG Technical Bulletin No. 17. June, 2000*

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

- Effect of Delivery on Neonatal Injury
- _Method_			_Death_		_ICH_		_Other* _
- SVD				1/5,000	1/1,900	1/216
- C/S labor		1/1,250		1/952		1/71
- C/S after OVD		1/333			1/38
- C/S no labor		1/1,250		1/2,040	1/105
- VD alone		1/3,333		1/860		1/122
- Forceps alone		1/2,000		1/664		1/76
- Vacuum and forceps	1/1,666		1/280		1/58
- *Facial nerve/brachial plexus injury, convulsions, central nervous system depression, mechanical ventilation
- Towner D, Castro MA, Eby-Wilkens E, Gilbert WM. Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 1999;341:1709–1714

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*How we cause it*
- Unnecessary procedure
- High risk procedure
- Inadequate skill of provider
- Unknown fetal parameters
- Prolonged application or multiple pop-offs
- No alternative delivery options available

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*Unnecessary procedure*
- Prolonged second stage alone is not an indication for immediate delivery
- Maternal exhaustion can be managed by maternal rest

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*High risk procedure*
- Low chance of success
- “Trial” of operative vacuum delivery
- Combination procedure with forceps
- Gestational age less than 34 weeks

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*Inadequately skilled provider*
- Provider need be credentialed in the procedure
- Provider must know the definitions of the different types of vacuum delivery
- Rocking movements should not be used

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*Unknown fetal parameters*
- Estimated fetal weight is critical to the procedural risks
- Station and position of the fetus must be known
- Resuscitation team not available

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*Prolonged application or multiple pop-offs*
- Cephalohematoma directly correlated with application time
- Multiple pop-offs are associated with CPD, fetal injury and failed procedure

## Quality Care in Obstetrics  Birth Trauma related to Vacuum Delivery

*No alternative delivery options available*
- Cesarean section not readily available
- There is a 3-5% unsuccessful rate of delivery
- Fetal concern often arises during the procedure

## Quality Care in ObstetricsPreventing Trauma with Vacuum Delivery

*Preliminary considerations*
- Consider alternative management
- High chance of success
- Exit strategy prepared
- Prepared patient
- Informed consent
- Resuscitation team available

## Quality Care in ObstetricsPreventing Trauma with Vacuum Delivery

*Technical considerations*
- Fetal parameters known and considered
- EFW, Station, Position
- Application time and pop-offs limited
- Torque in direct line of birth canal
- No rocking movements

## Quality Care in ObstetricsPreventing Trauma with Vacuum Delivery

*Bundle Components*
- Individual components supported by science
- Required to be performed for every patient, every time
- Bundle compliance measured by fulfilling all parts of the bundle
- Focus on system

## Quality Care in ObstetricsPreventing Trauma with Vacuum Delivery

*Vacuum Bundle*
- Alternative labor strategies considered
- Prepared patient
- Informed consent discussed and documented
- High probability of success
- EFW, fetal position and station known
- Maximum application time and number of pop-offs predetermined
- Exit strategy available
- Cesarean and resuscitation team available

## Tools for Bundle Success

- One stop documentation- all bundle elements rolled into a sticker/stamp for physician progress note as a reminder of what needs to be documented prior to the initiation of pitocin.
- Decision aids/reminders built into the system.
- Everyone on the same page and understanding of expectations.
**Make it easy!**

## Objectives

- Overview of the Project
- Introduce and define the concept of Idealized Design
- Use the perinatal bundles as examples in this design process
- Results

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