JOURNAL Oral or Vaginal Misoprostol for Labor Induction and

READING
Cesarean Delivery Risk: a Cohort Study
Roxane C. Handal-Orefice, MD, MPH, Alexander M. Friedman, MD, Sujata M. Chouinard, MD, Ahizechukwu C. Eke, MD, MPH, Bruce
Feinberg, MD, Joseph Politch, PHD, Ronald E. Iverson, MD, and Christina D. Yarrington, MD
By American College of Obstetricians and Gynecologist Vol. 134 No. 1 July 2019

Aditya Sadewa,S.Ked
Angel Chen,S.Ked
Arief Budiman,S.Ked
Doni Damora,S.Ked
Mardhiyatul Aflah,S.Ked
Nurul Humairah Arfiza,S.Ked
Nurul Ulya Rahim,S.Ked
Sonia Dinda Paramitha,S.Ked
Yulfhita Wahyu Rinaldi,S.Ked

SUPERVISORS:
dr. Sri Wahyu Maryuni, Sp.OG (K)
dr. Dafnil Akhir Putra, Sp.OG

KEPANITERAAN KLINIK SENIOR BAGIAN OBSTETRI DAN GINEKOLOGI

FAKULTAS KEDOKTERAN UNIVERSITAS RIAU
PEKANBARU
2019
 ABSTRACT
Objectives
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oral misoprostol increases
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cesarean delivery risk and prolongs time to vaginal delivery
compared with vaginal misoprostol.

Methods
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retrospective
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cohort study
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medical center and compared labor induction outcomes
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Time.vaginal misoprostol, Labor
induction using 25 micrograms vaginal misoprostol in 2013–2014 was compared with 50
micrograms oral misoprostol in 2014–2015. The primary outcome was cesarean delivery.

Results
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138 women.
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mass index was 31.7 (28.2–36.8) and most
will your Time.
women (72%) were of either black or Hispanic race or ethnicity. The frequency of cesarean
delivery was higher in the oral than the vaginal misoprostol group (32% vs 21%; P5.04).
Tachysystole occurredmore frequently with vaginal misoprostol (20% vs 11%; P5.04).

Conclusions
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Compared with vaginal
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that this Template may be associated with increased risk
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of cesarean delivery and longer time to vaginal delivery.
Introduction
According to the National Center for Health Statistics data from
2017, 25.7% of gravid women underwent labor induction, an increase from 23%

1 in 2012.

ARRIVE trial, which showed decreased risk for cesarean among

2 nulliparous women undergoing induction compared with expectant management.

Misoprostol, a synthetic prostaglandin E1 analog, is a common medication used

3 for cervical ripening during labor induction and is administered in various doses,
frequencies, and routes

In 2014, a Cochrane review on the use of orally administered misoprostol for labor
inductions suggested that vaginal misoprostol was less effective than oral misopros

4 tol at achieving vaginal birth, with an increased risk of uterine tachysystole and
cesarean delivery with vaginal misoprostol.

A subgroup analysis of the safest recommended dose of vaginal misoprostol

5 (25 micrograms) compared with a commonly used oral misoprostol dose
(50 micrograms)
 Method
Design Time
Cohort Retrospective Vaginal misoprostol : 2013-2014
Oral misoprostol : 2014-2015

Place Sample
Boston University Medical 138 females used vaginal
Center misoprostol and 138
females used oral
misoprostol
 1. They had a prior cesarean
SAMPLING 2.
delivery
They erroneously received
multiple forms of misoprostol
during their induction
3. The labor induction was
interrupted as a result of systems
issues such as floor acuity
INCLUSION

1. A live singleton pregnancy of at

least 34 weeks of gestation. EXCLUSION
2. A documented cervical examination
with dilatation of 1 cm or less.
3. Initiation of labor induction with
either vaginal misomisoprostol or To ensure accuracy and
oral misoprostol.
consistency of inclusion, two
investigator independently screned
the charts.
EXCLUSION FOR THE DERIVATION OFTHE
STUDY COHORT
DEMOGRAPHICS OF POPULATION
 Resident physicians and
attendings

Cervical examination

Dose Cervical Foley Catheter balloons

Oral : • Placed for up to 12 hours
Labor induction initiated with 50 mcg • Not used in rupture membrane
• remove before oxytocin induction
Vaginal :
Labor induction initiated with 25 mcg

Readminister every 4-6 hours if:

• Contraction < 4x in 10 min
• CTG category 1
• Bishop score < 7
Maximum 6 doses
CONFOUNDING FACTORS
 Outcome
Primary Outcome
Rate of Cesarean Delivery
The diagnosis of failure to
progress was obtained to
cesarean indication was
confirmed by operative and
documentation note.
Secondary Outcome
• Time to vaginal delivery
• Indication for cesarean
delivery
• Tachysystole
• Post-partum hemorrhage
• Neonatal mordibity
• Number of sterile vaginal
examination
• Number of misoprostol
dose required for induction
Data Analysis
• Unpaired t-tests for continuous data
• Chi-square test or Fisher’s exact test for categorical
data.
• ANOVA was used to analyze categorical variables with
more than one group.
• Nonparametric k-sample test on the equality of
medians was used to compare variables with integer
values.
• Laplace regression for censored time to events,
univariable and multivariable logistic
• Linear regression models were used to control for
prognostic covariates in time to event analyses,
categorical and continuous variables, respectively.
RESULT
RESULT
 Discussion

Our study
Oral misoprostol undergoes rapid absorption
from the gastrointestinal tract and rapid and
extensive de-esterification during first-pass Other Study
metabolism to an active metabolite. In contrast,
after vaginal misoprostol administration, plasma A double blind randomized trial comparing the
concentrations gradually increase, reaching a
maximum level after 70–80 minutes before
use of 25 micrograms of vaginal and 50
slowly being eliminated with plasma levels still micrograms of oral misoprostol showed similar
detectable 6 hours after administration. results to our study.

Compared with vaginal misoprostol, oral
misoprostol may be associated with increased risk
of cesarean delivery and longer time to vaginal
delivery
Shorter labor induction times, lower cesarean
delivery rates, and fewer required doses of
misoprostol to achieve vaginal delivery in the
vaginal misoprostol
group.
 Discussion
Our study
The study used design retrospective cohort to
analysis the compare oral and vaginal misoprostol
for labor induction. There were many potensial
bias.
To address this issue,
charts of women who presented for induction were
assessed in chronologic order by time of induction
and the first 138 women meeting criteria in each
group were included in the study to limit selection
bias. In addition, two investigators independently
screened the charts to ensure accuracy and
consistency of inclusion.
Other Study
a randomized trial including a total of 200 women,
using similar misoprostol doses as our study,
showed no significant difference in time to vaginal
delivery between the two groups, and a lower
cesarean delivery rate with oral misoprostol.
This study had more women with hypertensive
disease or preeclampsia in the vaginal (43%)
compared with oral misoprostol group (20%),
which may have confounded the results because
preeclampsia was the main indication
for cesarean delivery in this trial.
 P I C O
Problem Intervention Comparison Out Come

The oral misoprostol There was an

This study was conducted There were no and vaginal increased risk of
on women who received interventions in the misopostol for labor caesarean delivery
misoprostol on labor two study groups. induction and and prolonged labor
induction at the Boston caesarean delivery in a female
University Medical Center The study was risk. population
from 2013 to 2015. conducted with a (predominantly
retrospective cohort The control of this overweight) induced
The female population study study is the women using oral
included in this study used vaginal misoprostol versus
consisted of two groups misoprostol for labor vaginal misoprostol
ie women who were induction in 2013-
induced using vaginal 2014
misoprostol during 2013
to 2014 and those who
were induced using oral
misoprostol during 2014
to 2015.
12 Questions to make sense of a Cohort Study
Yes No Can’t
No Questions tell
A. Are the result of the study valid ?
1. Did the study address a clearly focused issue? V
2. Was the cohort recruited in an acceptable way? V
3. Was the exposure accurately measured to minimise bias? V
4. Was the outcome accurately meassured to minimise bias? V
5. (a) Have the authors identified all important confounding factors? V

(b) Have they taken account of the confounding factors in the design and/or V
analysis?
6. (a) Was the follow up of subjects complete enough? V
(b) Was the follow up of subjects long enough?
B. What are the results?
7. What are the result of this study? V
8. How precise are the results? V
9. Do you believe the results? V
C. Will the results help locally?
10. Can the results of this study fit with other available evidence? V
11. Do the results of this study fit with other available evidence? V
 CRITICAL APPRAISAL
Did the study address a clearly focused issue?
Yes. To evaluate whether cervical ripening with oral misoprostol increases
cesarean delivery risk and prolongs time to. vaginal delivery compared
vaginal misoprostol in a predominantly over weight population.
.
with 1
Was the cohort recruited in an acceptable way?
Yes. The all subject of this retrospective study identified based on inclusion
criteria and exclusion criteria of the oral misoprostol group and vaginal
misoprostol group.
2
Was the exposure accurately measured to minimise bias?
No, This study was not randomized trial. There is many demographic
criteria between vaginal misoprostol group and oral misoprostol group.
There is also difference time period during which each route misoprostol
3
was used and difference resident physician perfomed vaginal examination.
 CRITICAL APPRAISAL
Was the outcome accurately meassured to minimise bias?
Yes, primary outcome of this study was cessarian delivery risk and time to
vaginal delivery between oral and vaginal misoprostol
. for labor
. induction.
4

Have the authors identified all important confounding factors?

Yes. Confounding factors had to explain in Table 2 5a
Have they taken account of the confounding factors in the design
and/or analysis?
Yes. ANOVA was used to analyze cofounding factors with oral and vaginal 5b
misoprostol for labor induction.
 CRITICAL APPRAISAL

Was the follow up of subjects complete enough?

Yes. The subject of this study followed start. from pregnancy .until delivery. 6a
Was the follow up of subjects long enough?
Yes. Time of this study enough from the patient pregnancy until delivery.
This study used data medical record from 1 year used vaginal misoprostol
(2013-2014) and 1 year after switch to oral misoprostol (2014-2015)
6b
because of new protocol of the Cochrane in 2014.
 What are the result?

What are the 8 Do you believe How precise are

9
7

result of this the results? the results?

study?
This study used Yes. This study
ANOVA to analyze used appropriate
categorical variable data analysis.
with more than one
group. Also
95% Confidence
interval (aOR 2,01;
1,07-3,76)
withPvalue= 0,04
 Will the results help locally?

Can the results be applied to the

local population?

Yes. Vaginal misoprostol was easilly

used in medical facility.
Do the results of this study fit
with other available evidence?

Yes. The results of this study

have been supplemented by the
results of previous studies that
What are the implications of this have been written in journals.
study for practice?

Yes. The implication of this research

especially for the medical field is that
we can consider the indication for
cesarean except failed induction.
 Thank You
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