Synopsis 42 weeks of pregnancy is likely to be

Synopsis for the dissertation on Comparison of Mechanical induction, Chemical
induction or both in Post Term Pregnancy   ByDr. AREEBA ALIFCPS-II Trainee (Obstetrics and Gynecology)Ghurki Trust Teaching Hospital,
Lahore     Supervisor:PROF. NABEELA SHAMIProfessor of Obstetrics and GynecologyLahore Medical and Dental CollegeGhurki Trust Teaching Hospital,
Lahore      Date: _________                                                                                 Signature of Supervisor:    Introduction:Postdate
or post term pregnancy is the condition of a baby that has not yet been born
after 42 weeks or greater than 294 days of gestation, occur in 3% – 12% in
pregnancies. 88% women at 38 – 40 weeks go into spontaneous labor. Management
strategies for post-date of post term pregnancy include expectant management
and elective induction of labor.A women
who has reached 42 weeks of pregnancy is likely to be offered induction of
labor. Alternatively she can choose expectant management that is , she wait for
the natural onset of labor , women opting for expectant management may also
choose to carry on with additional monitoring of their baby with regular
Cardiotocograph (CTG) , Ultrasonography and Biophysical profile. Risk of expectant
management vary between studies.Women at
or beyond 41 completed week of gestation who were managed expectantly had a
higher risk of caesarian delivery (OR, 1.21CI, 1.01 – 1.46). But this
difference has not statistically significant in women at term than 41 completed
week of gestation (OR, 1.73CI, 0.67 – 4.5)Women
who was expectantly managed were more likely to have meconium stained amniotic
fluid then those who were electively induced (OR, 2.04 CI, 1.34 – 3.09)Induction
of labor as opposed to expectant management is increasing in United States from
9.5% of birth in 1990 to 23.3% of birth in 2010 and it decreases the risk of
caesarian deliveries and fetal distress.Various
method for induction of labor are available:Ø 
 Mechanical Induction (Non pharmacological e.g.
Foleys)Ø 
Chemical
Induction (Pharmacological e.g. prostaglandin E2) Ø 
Both
(Mechanical Induction followed by Chemical Induction)Complication
related to Mechanical induction (Foleys) is infections.Prostaglandin
E2 has been used for induction of labor since 1960. Vaginal Prostaglandin E2
increases the likely hood of vaginal delivery within 24 hours. However the risk
of uterine hyper stimulation with fetal heart rate changes is increased 4.6%. The
rate of vaginal delivery within 24 hours is 68% for both Mechanical induction
followed by Chemical induction. 48 % with mechanically and 52% with chemically.This
study is designed to compare the Efficacy of Mechanical induction alone,
Chemical induction alone and Mechanical followed by Chemical induction in post
term pregnancy for induction of labor can be promoted.Rational:The
clinically and early ultrasonography measurement of post term pregnancy in
which we  used mechanical induction alone
like Foleys , Chemical induction alone like prostaglandin E2 and mechanical induction
followed by chemical induction (Foleys followed by prostaglandin E2 ) can be
used. No such study has been done in our population. Therefore I have planned
to determine Efficacy of Mechanical induction, Chemical induction and
Mechanical followed by Chemical induction. My study will pave the way for
further researches in this topic and help us in induction of labor in our
general population.  Objective:The
objective of the study is to compare the efficacy of Vaginal Foleys alone,
Prostaglandin E2 alone and both for induction of labor in post term pregnancy.Operational definitions:Ø  Induction of
Labor :Labor
induction is the initiation of uterine contraction prior to their spontaneous
onset leading to cervical dilatation, effacement and delivery of fetus.Ø  Post term Pregnancy:Post
term pregnancy is the condition of the baby has not yet born after 42 weeks of
gestation or greater than 294 days from last menstrual period.Ø  Efficacy:Efficacy
is mode of induction is measured by rate of vaginal delivery within 24 hours.Hypothesis:There is
a difference in the efficacy of Foleys alone, Prostaglandin E2 alone and Foleys
followed Prostaglandin E2 for induction of labor in post term pregnancy.Material and Method:Study Design:                          Randomized
clinical trialsSetting:                                    Unit-I,
Department of Obstetrics and Gynecology, Ghurki Trust teaching hospital,
Lahore.Duration
of Study:                  Study will be conducted 6
Months from approval of synopsis.Sample
size:                            Calculated sample
size is 60 cases in each group, with 10% margin of error, 80% power of study
taking expected percentage of vaginal delivery i.e. 68% in both (Foleys
followed by Prostaglandin E2, 48% with Foleys alone and 52% with Prostaglandin
E2)Sampling
Technique:              Non probability purposive
Sampling.Sample
Selection: Inclusion
Criteria:Ø 
All
pregnant patient of 20 – 40 year of age with post term at 42 weeks assessed by
date of last menstrual period or earliest of Obstetrical Ultrasonography .Ø 
Cephalic
presentation.Ø 
Adequate
amniotic fluid.Ø 
Cardiotocograph
reactive.Ø 
No
any pelvic pathology.Ø 
Bishop
Score < 5.  Exclusion Criteria:All pregnant patient with following risk factor identified on the basis of history, clinical examination, Obstetrical ultrasonography and Cardiotocograph.Ø  Previous lower segment C- section.Ø  Breech presentation.Ø  Placenta previewØ  Malposition.Ø  Placental abruption.Ø  Twin pregnancy.Ø  Cephalopelvic.Ø  Fetal.Ø  DisproportionØ  Fetal DistressØ  CorioamniotisData Collection:100 patients full filling the inclusion criteria will be included in study through emergency of department of Obstetrics and Gynaecology, Ghurki Trust Teaching Hospital, Lahore informed consent will be taken from the patients after explaining about the drug used, cost of drug and procedure opted in the study. Patient will be divided randomly into three groups A, B and C using random number table. Assessing of postdate will be made on the basis of history of last menstrual period or earliest Obstetrical ultrasonography. In history patient will be inquired about total number of baby she have and last menstrual period to rule out her estimated date of delivery.  On abdominal examination fundal height, lie, estimated fetal birth rate, adequate amniotic fluid will be noted down. On sterile speculum examination per vaginal leaking will be confirm present or not. On digital vaginal examination Bishop Score will be assessed. Group A will be induced with Foleys alone per vaginally inflated with 60CC of distilled water for 6 hours. Group B will induced vaginal prostaglandin E2 1 mg after every 6 hours up to 3 doses. Group C will induced with Foleys for 6 hours followed by Prostaglandin E2 1mg after every 6 hours up to 3 doses. Time of onset of uterine contraction and time of delivery will be noted down. All this data will be recorded on the Performa attached.Data Analysis:Information collected will be enter into the SPSS (V.11) and will be analyzed. Age of patient, gestational age, time of onset of uterine contraction and tome of delivery will be analyzed by mean and standard deviation, parity and Bishop Score by proportion and percentage. The time taken to start uterine contraction and induction to delivery time will be compared, "t" test will be used as test of significance. P ? 0.05 will determine the level of significance.     

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