RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGLORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE : DR.REEJA M MATHEW

(SR.REEJA MATHEW)

ADDRESS : DEPARTMENT OF

OBSTETRICS AND

GYNAECOLOGY

ST.JOHN’S MEDICAL

COLLEGE .BANGALORE

2 NAME OF THE INSTITUTE : ST.JOHN’S MEDICAL

COLLEGE HOSPITAL

BANGALORE-560034

3. COURSE OF STUDY AND

SUBJECT : MS OBSTETRICS AND

GYNAECOLOGY

4 DATE OF ADMISSION TO THE

COURSE : 18th MARCH 2009

5 TITLE OF THE TOPIC : COMPARISION OF

ULTRASONOGRAPHIC

CERVICAL LENGTH &

BISHOP SCORE IN

PREDICTING

SUCCESSFUL LABOUR

INDUCTION.

6. BRIEF RESUME OF THE INTENDED STUDY:

6.1 NEED FOR THE STUDY:

Labour induction is one of the common interventions in obstetric practice. Assessment of cervix has been used as a predictor of the successful vaginal delivery. Traditionally, the bishop score has been used to assess the cervix. Bishop originally observed that nulliparous women undergoing induction of labour with a cervical score >8 had the same likelihood of vaginal delivery as did women in spontaneous labour1.Labour induction with a low cervical score has been associated with failure of induction , prolonged labour , and a high rate of cesarean deliveries.

Recently, transvaginal ultrasonographic measurement of cervical length has been linked with the risk of preterm delivery2 Cervical shortening, as seen in sonograms, has been proposed as representative of the process of cervical effacement3.Theoretically, transvaginal ultrasonographic measurement could represent a more accurate assessment of the cervix more than digital examination because the supravaginal portion of the cervix usually comprises about 50% of cervical length. Moreover, the effacement is more difficult to determine in the closed cervix. In contrast, Trans vaginal

Ultrasonographic cervical measurement is quantitative and easily reproducible.

A text book of obstetric described a successful labour induction as the initiation of labour4. Active labour ,represented by cervical dilatation of 3-4cm or greater in the presence of uterine contractions , is usually considered a reasonable threshold for diagnosis of labour because of the uncertainties in diagnosing true labour during earlier stages of cervical dilatation .This study is designed to investigate trans vaginal ultrasonographic cervical measurement as a predictor of duration of labor and successful induction resulting in vaginal delivery and also compare the performance of ultrasonographic cervical measurement with that of the Bishop score in predicting the outcome of labour induction.

6.2 REVIEW OF LITRATURE:

Induction of labour means initiation of uterine contractions by any method (medical, surgical, combined) for the purpose of vaginal delivery. The condition of the cervix or favorability is important to the

Success of labor induction. One quantifiable method predictive of an outcome of labour induction is that described by Bishop (1964)

Elements of the Bishop score

FACTOR

SCORE / Dilatation / Effacement % / Station / Cervical Consistency / Cervical Position
0 / Closed / 0-30 / -3 / Firm / Posterior
1 / 1- 2 / 40-50 / -2 / Medium / Mid position
2 / 3-4 / 60-70 / -1 / Soft / Anterior
3 / ≥5 / >80 / +1, +2 / - / -

A score of 9 conveys a high likelihood for a successful induction. Most practitioners would consider that a woman whose cervix is 2 cm dilated, 80 % effaced, mid position and with the fetal occiput at -1 station would have a successful labour induction

Many studies have done for the prediction of the Bishop Score and transvaginal ultrasonography in successful labour induction. Some studies show cervical length is a better predictor of success in labour induction and

Some says transvaginal ultrasonographic evaluation of cervical length before induction does not improve the prediction of cervical inducibility obtained by the Bishop score.

A study done in Europe showed that successful induction and duration of labour were significantly associated with the Bishop score and cervical length. In a logistic regression model that included these parameters as independent variables, only the Bishop score and the parity were significantly correlated with successful induction5

Khoury et al demonstrated that all women with cervical length < 3 cm delivered vaginally , in comparison with 73% of those with cervical length >3 cm ,the former group also had a significantly shorter labour6.

Gomez et al found that cervical length is a better predictor than Bishop Score .Sensitivity and specificity of 66% and 77% versus 77% and 56% respectively. The only component of Bishop Score that was independently predictive of the probability of vaginal delivery is station7.

Xenakis et al reported that 34% of nulliparous women who had a Bishop score <3 and who underwent medically indicated induction has cesarean delivery8.

6.3  OBJECTIVES OF THE STUDY

1. To compare the predictive value of the Bishop score transvaginal ultrasonography in successful labour induction.

2. To estimate the most useful cut off points for the two methods.

7  MATERIALS AND METHODS

STUDY DESIGN - Prospective study.

SAMPLE SIZE AND SOURCE OF DATA

100 primi gravida with gestational age ranging between 37-42wks who are admitted under Obstetrics & Gynecology in St John’s Medical college Hospital.

A minimum sample size of 100 is planned.

DURATION OF STUDY

1st September 2009 to 1st March 2011

INCLUSION CRITERIA

1.  Nulliparous patients

2.  Singleton pregnancy

3.  Live fetus with vertex presentation.

4.  Intact amniotic membranes.

5.  Gestational age between 37- 42 wks.

6.  Reassuring N S T pattern before induction.

7.  No contraindications for vaginal delivery.

8.  Patients who are willing to give consent for the study.

EXCLUSION CRITERIA

1. Vaginal bleeding.

2. Allergic to prostaglandins.

3. Patients in active phase of labour.

4. History of uterine surgery like previous LSCS, myomectomy.

5. Presence of severe maternal or fetal compromise such as

Severe PIH, Severe IUGR, cardiac disease etc ….

METHOD OF COLLECTION OF DATA

All patients who are willing to participate in this study will be evaluated as per the proforma. After informed consent is obtained, Trans vaginal ultrasonographic measurement of cervical length is performed with the standard longitudinal view of the cervix while the patient’s bladder is empty. GE VOLUSON 730 PRO TVS Probe IC 5-9 H. instruments with 5-9 MHz is using to measure the cervical length. Cervical length is measured by keeping the probe 3cm away from the posterior fornix. The cervical length is defined as the length between the internal and external OS.

After sonography the Bishop Score is determine by the digital examination of the resident physician responsible for the induction. Physicians were masked to the cervical length measurement.

Induction of labour is carried out according to the standard protocol of our hospital. Prostaglandin E2 gel is inserted into the cervical canal within 1 hr of cervical assessment. The patient is reassessed after 12 hrs. If she did not exhibit regular uterine contractions and cervical change, a second dose of PG E2 is administrate intracervically. Maximum of 3 doses can be repeated. Subsequent dose is withheld if;

a)  The patient is in active labour.

b)  Rupture of membrane.

c)  If cervical effacement > 60 % & os ≥ 3 cm.

d)  Regular uterine contractions 2-3 in 10 minutes.

Augmentation of labour is done as per labour room protocol.

Active phase of labour is diagnosed as 3-4 contractions in every 10 minutes, each lasting for 45 to 60 sec9. And the cervix is dilated ≥ 3 cm and the effacement of cervix is 80 % or greater. Successful induction of labour is defined as active labour occurring at the end of induction protocol (12 hrs from the last dose)

Failed induction is defined as an inability to achieve the active phase of labour corresponding to cervical dilatation of ≥ 3 cm within 12 hrs from the last dose of PG E2

Failure to progress is defined as no cervical dilatation during the active phase of labour for the last 2 hrs or no descent of the fetus’s head during the second stage of labour for at least 1 hr despite adequate uterine contractions. This is considered as an indication for cesarean delivery for failure to progress10.

Primary outcome measures assessed are:

1.  Induction – Active phase interval.

2.  Mode of delivery.

3.  Duration of induction to delivery.

Secondary outcome measures assessed are:

1 LSCS for non progression of labour

2. Incidence of failed induction.

7.3 Does the study require any investigations or interventions to be conducted on patients or animals?

Yes

Trans vaginal ultrasonographic cervical length induction of labor with PGE2 gel

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes

LIST OF REFERENCES

1.  Bishop E H. Pelvic scoring for elective induction. Obstet. Gynecol. 1964; 24: 266-8.

2.  Iams J D et al . The length of cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human development Maternal- Fetal Medicine Units Network. N Engl J Med 1996; 334: 537- 72.

3.  Vonda Ware et al. Transvaginal Ultrasonographic cervical measurement as a predictor of successful labor induction .AJOG 182 (5) : 1030-32 May 2000.

4.  Induction and augmentation of labor In Cunningham FG, gant M F, Leveno K J, Gilstrap L C, Hauth J C, Wenstram K D. (Eds) Williams Obstetrics, 21st Ed. New York, NY: MC Graw- Hill; 2001: 469-481.

5.  Gonen R, Degani S, Ron A prediction of successful induction of labor; comparison of transvaginal ultrasonography and the bishop score. Eur J Ultrasound. 1998; 7: 183-7.

6.  Khoury s, Odeh M, Korshonov M,Wolfsom M,Oettinger M ,Transvaginal evaluation of the cervix before induction of labor. In proceeding of eighth World Congress of Ultrasound in Obstetrics and Gynecology 1997 , Washington ,D C Washington ; The Congress 1997

7. Gomez Laencina A M, Sanchez F G, Gimenez J H, Acta Obstet

Gynecol Scand .2007; 86(7): 799-804.

8. Xenakis E M, Piper J M, Conway D L, Langer O .Induction of labor in

nineties; conquering the unfavorable cervix. Obstet Gynec

1997;90:235-9.

9. Harry Oxorn; Oxorn – Foote Human labor and Birth 5th Ed: 669.

10. Kyo Hoon Park. Transvaginal ultrasonographic cervical measurement

in predicting failed labor induction and cesarean delivery for failure to

Progress in nulliparous women. J Korean Med Sci 2007, 22: 722-7.

PROFORMA

NAME : AGE:

OP/ IP NO. :

OCCUPATION:

LMP: EDD:

G A at intervention:

Indication for induction of labor:

Obstetric Complications :

Medical Complications :

USG Findings :

Gestational Age :

Expected fetal weight :

Amniotic fluid index :

Cervical Length :

BISHOP SCORE

Dilatation / Effacement / Station / Cervical consistency / Cervical position

TOTAL SCORE:

Induction to active phase interval:

Induction to Delivery interval :

Mode of delivery

a) Vaginal :

b) Vaginal instrumental :

c) LSCS :

Indication for LSCS :

Indication for instrumental

Delivery :

Fetal outcome

a) Birth weight :

b) Apgar Score

1 minute :

5 minute :

Neonatal ICU Admission :

Indication for ICU Admission :

9. SIGNATURE OF THE CANDIDATE :

10. REMARKS OF THE GUIDE : Pre induction transvaginal measurement of cervical length if found to be a better predictor than the bishop score (which has been used traditionally) of the successful outcome of the induction of labour, could be incorporated in the pre induction protocols. It could then be useful in better counseling of the patients regarding the outcome of induction of labour.

11. NAME AND DESIGNATION OF

11.1 GUIDE : DR. SHEELA C N MD

PROFESSOR

DEPARTMENT OF OBG

ST.JOHN’S MEDICAL

COLLEGE HOSPITAL

BANGALORE -560034

11.2 SIGNATURE :

11.3 HEAD OF DEPARTMENT : DR. ANNAMMA THOMAS M D

PROFESSOR & HOD

DEPARTMENT OF OBSTETRICS

AND GYNAECOLOOGY

ST.JOHN’S MEDICAL

COLLEGE HOSPITAL

BANGALORE -560034

11.4 SIGNATURE :

12. REMARKS OF CHAIRMAN AND PRINCIPAL:

12.1. REMARKS :

12.2. SIGNATURE :