Statistical modeling in pharmaceutical research and development.
An update INDUCTION OF LABOR : WHO, WHEN, HOW ,WHERE & OUTCOME DR. SHARDA JAIN DR. JYOTI AGARWAL
1. An update
INDUCTION OF LABOR :
WHO, WHEN, HOW ,WHERE
& OUTCOME?
DR. SHARDA JAIN
DR. JYOTI AGARWAL
2. Over 300 PPTs are available on slideshare.net
***for use of public/Doctors
www.slideshare.net / Lifecarecentre
3.
4. KEY LEARNING POINTS of
INDUCTION OF LABOR (IOL)
Definition , Incidence, Rationale
Evidence of SAFETY mother & baby
• INDICATION & Contraindications for IOL
• Pre-induction assessment
• Monitoring
• Outcome risk of IOL
• Methods except (PG)
• Special conditions & IOL
…..Caring hearts, healing hands
5. IOL..first mentioned HIPPOCRATES
• The …NIPPLE STIMULATION OR MECHANICAL
METHODS
NOW…
• MOST USED
• MOST EFFECTIVE INTERVENTIONS IN MODERN
OBSTETRICS.
“EXACT KNOWLEDGE ON WHOM,WHEN,WHERE
HOW HAS BEEN LACKING”
NO CONSENSUS BASED ON LARGE RCTs
6. OUR FOCUS WILL BE ON
5 RIGHTS
• Right Patient
• Right Time
• Right Medication
• Right Dose
• Right Route
+
• Outcome (Safety & Efficacy)
• You should be also clear - What method of IOL
should I use, when and for whom ?
…..Caring hearts, healing hands
7. DEFINITIONS
IOL initiation of contractions in a pregnant woman who is
not in labour to help her achieve a vaginal birth beyond
period of viability.
• Successful induction :vaginal delivery within
24 to 48 hs of IOL.
• Elective: I O L in the absence of acceptable fetal or
maternal indications.
• Cervical ripening :use of pharmacological or other means to
soften, efface, or dilate the cervix to increase the likelihood
of a vaginal delivery.
…..Caring hearts, healing hands
8. FEW CRITERIA TO BE
REMEMBERED
• TACHYSYSTOLE 0r HYPERTONUS
* 5 C/10 m period averaged over 30 m.
• HYPERTONUS EXCESSIVE - Uterine contractions
lasting > 120 sec tachysystole or with
• TACHYSTOLE with or without FHR changes.
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9. INCIDENCE
The incidence of induction of
labor is
20% in the UK,
30-40% in the USA
10% in India
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10. RATIONALE OF IOL
• IOL is indicated when a continuation of the
pregnancy would mean that the Risks to the
mother or fetus Outweigh the benefits from
Further observations of expectant tt
• The aims of induction are straight forward—vaginal
delivery in 24 hours or active labor within 12 h.
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11. Benefits should be weighed,
Risks should be assessed,
Alternatives should be considered,
Necessity of intervention adjudged &
Decision should be taken accordingly
BUT,
INDUCTION OF LABOR
INJUDICIOUS USE OF LABOR INDUCING
AGENTS SHOULD BE AVOIDED
12. We
• IOL is the beginning of a cascade of
intervention…bcz she is in HOSPITAL…
• All is….not good for mothers or babies
• Trained in the last century
13. UNDESIRABLE
OUTCOMES OF IOL
Undesirable outcomes have been clearly defined by the
COCHRANE COLLABORATION Pregnancy and
Childbirth Group and include:
• Vaginal delivery not achieved within 24 h;
• Uterine hyper stimulation with fetal heart rate changes;
• Requirement for cesarean section;
• Serious neonatal morbidity or perinatal death;
• Serious maternal morbidity or death
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15. WHAT WE WANT?
Safety& Effectiveness
IOL at term TO IMPROVE
birth outcomes
–Reduces perinatal deaths
–Reduces rate of CS or no increase
–AIM… best baby /Mother outcome
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26. TAKE HOME MESSAGES
MODERN IOL at term IMPROVES
birth outcomes
–Reduces perinatal death
–Reduces rate of CS or no increase
–AIM…Not earlier than 39 WEEKS
for best baby outcome
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27. WHEN TO INDUCE ?
**Not earlier than 39 wks
as far as possible
*stretch to 41 wks if uncomplicated
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28. MATERNAL INDICATIONS
1. Maternal diseases, e.g.
1.DIABETES MELLITUS * - uncontrolled
2. Post term pregnancy * - 40 v/s 41 v/s 42
3. HYPERTENSIVE DISEASES * - 38 - 39
4. Autoimmune diseases, e.g. systemic lupus erythematosis
5. Renal disease – with renal function deterioration
2. Pre- labor spontaneous rupture of membranes (PROM)*
3. Pregnancy related condition
1. PRE-ECLAMPSIA *
2. INTRAHEPATIC CHOLESTASIS OF PREGNANCY *
4. Previous Caesarean section ?
5. Maternal age * 6. Maternal request *
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29. FETAL INDICATIONS
1. INTRAUTERINE FETAL DEMISE *
2. Lethal fetal malformations
3. FETAL (INTRAUTERINE) GROWTH
RESTRICTION mild/severe *
5. Oligohydramnios with IUGR
6. Rh- isoimmunization – does not bother these
days
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30. CONTRAINDICATIONS
Where vaginal delivery is contraindication
• Placenta Previa
• Cord Presentation
• Active Genital Herpes
• Previous Uterine Scar (midline or inverted T)
• If IOL threatens fetal or maternal compromise
…..Caring hearts, healing hands
31. GUIDELINES
SOGS 2013 / WHO 2011/ NICE 2008
1. Must document : Reason for induction,
Method of induction, risks, including failure
to achieve labour and
possible increased risk of CS. (III-B)
2. If IOL is unsuccessful: indication and method
of induction should be re-evaluated. (III-B)
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32. 3. IOL should not be performed solely for
suspected FETAL MACROSOMIA. (III-D)
4. IOL should not be performed solely because of
PATIENT OR CARE PROVIDER PREFERENCE. (III-D)
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GUIDELINES
SOGS 2013 / WHO 2011/ NICE 2008
33. UNACCEPTABLE INDICATIONS
• Care provider or patient convenience
• Suspected Macrosomia (E F Wt > 4000 gm) in
a non-diabetic =no reduction in the incidence
of shoulder dystocia but twice the risk of CS.
IOL at term is not recommended for suspected
Macrosomia (WHO, 2011)
• Gestational diabetes IOL not recommended
before 41 wks (WHO, 2011).
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34. OTHER INDICATIONS
• Maternal request IOL should not routinely be offered.
However, under exceptional circumstances at or after 40 w
(NICE, 2008).
• FETAL GROWTH RESTRICTION
If severe , IOL is nor recommended
(NICE ,2008)
• POST DATE INDUCTION
IOL between 41+0 and 42+0 w {reduce perinatal mortality
and meconium aspiration syndrome without increasing CSR}.
(I-A)
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35. RCOG RECOMMENDATIONS
in Special circumstances
IUGR - severe FGR with fetal compromise- IOL is not recommended
*****
PROM- <34 wks-expectant mgt.
> 34wks---intravaginal PGE2
Wait as far as possible
*****
PREVIOUS CS
PGE2 & oxytocin is safe in patients who are candidates for VBAC.
PGE1 contraindicated.
IUD- labour induced with oral mifepristone
(200mgdaily *2days)
followed by vaginal PGE2 or PGE1
IUD WITH PREVIOUS CS - dosage of PG should be reduced.
36. SUMMARY OF PRACTICES IN USA
• Stripping of membranes at 39 wks.
• ARM only in active phase of labour.
delay ARM in O.Posterior position.
• LONG RIGID CX –Foleys catheter /misoprost
PROSTAGLANDINES ONLY when cervix is unripe.
Misoprostol low dose regime - 25 micro gm 6 hrly.
• PET/IUGR …..Oxytocin start as- low dose in NS.
Do ARM before oxytocin.
AVOID COCKTAIL REGIMEN…
MIX & MATCH
37. WHAT DO WOMEN WANT ?
• Women preferred induction of labor
to serial antenatal monitoring
Monitoring needed
USG / NST b/w after
40 wks
39. Factors influencing success rates of
induction
1. Bishop score
2. Parity (prior vaginal delivery)
3. BMI 4. Maternal age 5. EFW 6. DM.
Elevated BMI (> 40 kg/m2)
Maternal age > 35 y
EFW > 4 kg
DM: increase the CS rate when labour is induced
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40. MODIFIED BISHOP’S SCORE
Ease of IOL = ripeness of the cervix
SCORE
0 1 2 3
Cervical
Dilatation (cm)
0 1-2 3-4 5-6
Cervical length
(cm)
>4 3-4 1-2 <1
Cervical
consistency
Firm medium soft
Cervical position Posterior central Anterior
Station (cm in
relation to
spine)
-3 above spines -2 above spines -1 to 0 above
spines
Below spines
Total score 13
0-5
favorable Score 6-13 Unfavorable score
Substitute the length of labor for % of effacement
41. MODIFIED BISHOP’S SCORE
*A Score of 8or more
generally indicates that the cervix is ripe or
favorable – when there is a high chance of
spontaneous labor or a good predicted response
to IOL.
*An UNFAVORABLE CERVIX can be made
favorable by using Vaginal prostaglandins
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42. BISHOP SCORE
• 0 to 3: highest risk of failed induction and CS
in both nulliparous and parous.
• 4 to 6: significantly higher risk of CS than
those with spontaneous labour.
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43. EVIDENCES & GUIDELINES REGARDING
BISHOP SCORE
SOGS 2013 / WHO 2011/ NICE 2008
• To determine the likelihood of success and To select the
appropriate method of induction. (II-2A)
• The Bishop score should be documented. (III-B)
• Induction of women with an unfavourable cervix is
associated with a higher failure rate in nulliparous
patients and a higher CS rate in nulliparous and parous
patients. (II-2A)
…..Caring hearts, healing hands
44. IDEAL AGENT
*THE IDEALAGENT MUST EFFECTIVE
*Must be safe
& induce labor and convert an unfavorable
cervix to one receptive to delivery,
*easy to administer, and
*acceptable to the patient.
…..Caring hearts, healing hands
45. HOW TO INDUCE ?
Methods
(EFFECTIVENESS & SAFETY)
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46. METHODS OF INDUCTION OF
LABOR
The various methods of induction of labor are as follow
1. TRADITIONAL METHODS 2. MEDICAL METHODS
* Prostaglandins PGE2 & PGE1
* Oxytocin
3. SURGICAL
* Strippingof membranes * Amniotomy
4. COMBINED : medical & surgical
5. MECHANICAL : *foley’s catheter – EASI (extra- amniotic saline infusion)
6 NEWER RESEARCH AGENTS
* Nitric oxide donors * Relaxin *Antiprogesterones like mifepristone
* Interleukin – 8 * Buccal oxytocin
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47. TRADITIONAL METHODS
1. Castor oil √
2. Acupuncture x
3. Herbal Remedies x
4. Nipple Stimulation x
Most have become
HISTORY
48. SWEEPING OF MEMBRANES
(stripping}
• Sweeping of Membranes (stripping} –
encourages the onset of spontaneous labor &
reduces need of formal IOL
‘8 sweeping’ to
avoid one IOL
No infection
…..Caring hearts, healing hands
49. SWEEPING OF MEMBRANES
(WHEN?)
1. At 40& 41 w in nulliparous
2. At 41 w in parous
3. When a vag exam is carried out to assess the
cervix
4. Labour does not start spontaneously.
(NICE, 2008)
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51. EVIDENCES & GUIDELINES FOR
AMNIOTOMY
AMNIOTOMY ALONE is not recommended for IOL. (WHO, 2011)
• AMNIOTOMY SHOULD BE RESERVED FOR WOMEN WITH A
FAVOURABLE CERVIX.
Particular care should be given in the case of
unengaged presentation {risk of cord prolapse}. (III-B)
• After amniotomy, oxytocin should be commenced
early in order to establish labour. (III-B)
…..Caring hearts, healing hands
52. MECHANICAL methods
(Balloon catheter or Laminaria tents)
• Are not used any more
• Efficacy - not clear
• Not superior to PG
• only to be when PG
are not avalable
EASI
54. Novel Formulation of Prostaglandins
for Induction of Labour
Dinoprostone Vaginal Pessary
(sustained release)
Dr.Jyoti Agarwal
THIS PRESENTATION IS AVAILABLE ON
SLIDESHARE.NET
56. OXYTOCIN REGIMEN
• Oxytocin is the most frequently used method for
induction of labor in INDIA & is more effective after
Amniotomy.
• Different strength of oxytocin can be used like 2 units, 5 units
or 10 units in 500 mL of ringer lactate or normal saline
solution. The aim is to start with 2 milli unit per minute &
increasing stepwise every 30 minutes ,
until uterine contractions occur in
every 3 minute in primigravda women
57. OXYTOCIN REGIMEN (1ML = 16 DROPS)
1 UNIT = 1000 MILLI UNITS (MU)
Drops per minutes Dose in mU/ minute 2
units in 500 mL ringer
lactate or normal saline
Dose in mU minute 5
units in 500 mL of ringer
lactate or normal saline
solution
8 2 5
16 4 10
32 8 20
48 12 30
64 16 40
80 20 50
IN LOW DOSE REGIMEN . 2 mU / minute is given with increase at rate of 2 mU
every 30 minutes.
IN HIGH DOSE REGIMEN : 6 mU/ minute is given with increase at rate of 6 Mu
every 15 minutes
58. OXYTOCIN EXAMPLE OF
LOW-DOSE PROTOCOL: INITIAL DOSE OF
oxytocin..................................1 to 2 mU/min Increase
interval......................................................30 minutes
Dosage increment....................................................1 to 2 mU
Usual dose for good labour.........................8 to 12 mU/min
Maximum dose before reassessment.................30 mU/min
EXAMPLE OF HIGH-DOSE PROTOCOL: INITIAL DOSE OF
oxytocin..................................4 to 6 mU/min Increase
interval............................................15 to 30 minutes Dosage
increment...........................................4 to 6 mU/min Usual
dose for good labour.........................8 to 12 mU/min
Maximum dose before reassessment.................30 mU/min
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59. MONITORING
1. Fetal well-being (CTG) at addmision
2. for 30 m after administration of oxytocic
agent
3. for 60 m after any Tachysystole
BISHOP SCORE
Maternal & fetal monitoring
Once active labor is established
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60. OBSERVATIONS DURING IOL
with OXYTOCIN
• Continuous fetal heart monitoring
• Auscultated every 15 minutes
• Uterine contractions should also be observed for
their frequency & duration in 10 minutes.
• Rate of flow of infusion should be noted
• Maternal condition particularly pulse , BP &
chest auscultation should be observed regularly
• Ideally , partogram
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61. Advantages of oxytocin for
induction of labor
ADVANTAGES OF OXYTOCIN
• Cheap
• Widely available
• Less systemic side effects compared with
prostaglandins
• In case of uterine hyperstimulation, stopping
infusion results in rapid fall in plasma levels
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62. DISADVANTAGES OF OXYTOCIN
FOR INDUCTION OF LABOR
Disadvantages
• It has anti diuratic effect & risk of water
intoxication & hypo-natremia, if high doses are
used.
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63. PG VAGINAL E2 PESSERY
IS THE BEST
OXYTOCIN induction which we use is LESS
EFFECTIVE THAN PROSTAGLANDINS
70% v/s 20%
when cervix is unfavorable,
in cases of intrauterine death &
in early gestational period
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66. OUTCOME OF IOL
• IOL IS SUCCESSFUL IN MAJORITY OF CASES.
• 2/3rd WOMEN GIVE BIRTH VAGINALLY
WITHOUT ANY MORE INTERVENTION.
• 15 % HAVE INSTRUMENTAL BIRTHS.
• NERLY 20..22% WILL NEED EMERGENCY LSCS
• FAILED INDUCTION :15%
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67. KEY LEARNING POINTS
• Induction of labor is one of the most effective
interventions in Modern obstetrics. When timed
properly, it can prevent serious complications for
mother & child , with little additional risk for the
neonate & without an increased risk of caesarean
section.
• For many maternal indications, evidence for the
optimal timing of induction has been elucidated
preferring timing at term.i.e.39 weeks.
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68. • When preterm induction is considered it should offer
maternal & / or fetal benefits.
• In case of an unripe cervix, mechanical induction with
trans cervical balloon & oral misoprostol are
considered safe methods.[USA ]
• When induction of labor has failed the condition of
both mother & child should be the indicator for
further decision making instead of induction times
KEY LEARNING POINTS
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69. ADDRESS
11 Gagan Vihar, Near
Karkari Morh Flyover,
Delhi - 51
CONTACT US
9650588339
9599044257
011-22414049
WEBSITE :
www.lifecareivf.in
www.lifecarecentre.in
www.lifecareabs.in
ISO 14001:2004 (EMS)
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Helpline : 9599044257
Web.www.lifecareivf.in
Helpline : 9910081484
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