Thesis Carbetocin Vs Oxytocin
Thesis Carbetocin Vs Oxytocin
Thesis Carbetocin Vs Oxytocin
TITLE
CARBETOCIN VERSUS OXYTOCIN USE IN STANDARD
ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR
(AMTSL) FOR PROPHYLAXIS OF POSTPARTUM
HEMORRHAGE IN VAGINAL DELIVERY
BY:
Dr. SHIKHA SINGH
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
S.N. MEDICAL COLLE GE
PROFORMA FOR THE THESIS FOR MASTER OF SURGERY
(OBSTETRICS AND GYNAECOLOGY)
ATAL BIHARI VAJPAYEE MEDICAL UNIVERSITY, LUCKNOW, UTTAR PRADESH
(2022-2025)
TITLE : CARBETOCIN VERSUS OXYTOCIN USE IN ACTIVE MANAGEMENT OF
THIRD STAGE OF LABOUR (AMTSL) FOR PROPHYLAXIS OF POSTPARTUM
HEMORRHAGE IN VAGINAL DELIVERY
CERTIFICATE:- It is certified that Aims , objectives, material and methods have been checked and approved.
The work is feasible and statistician has been consulted .
INTRODUCTION
The incidence of PPH has been reported to be 3.9 % in women who delivered
vaginally.7
Aim:
Objectives:
During the second half of the 20th century, a package of interventions performed
during the third stage of labour became the cornerstone for the prevention of PPH.
According to the WHO and other professional organisations, third-stage labour
should be actively managed to prevent PPH. This approach became known as the
”Active management of the third stage of labour(AMTSL)-” and consisted
initially of the following components:13 -
UTEROTONIC-Administration of a prophylactic uterotonic immediately after
the delivery of the baby.
DELAYED CORD CLAMPING-Delayed clamping the cord for at least 1-3
minutes.
-Controlled traction of the umbilical cord perform ,if required.
POSTPARTUM VIGILANCE-Immediately assess uterine tone to ensure a
contracted uterus ,continue to check every 15 minutes for 2 hours, If there is
uterine atony ,perform fundal massage and monitor more frequently.
In contrast to active management, expectant management involves instead
waiting for signs of placenta separation and allows for the placenta to be delivered
spontaneously, or aided by nipple stimulation or gravity. Compared with
expectant management, the active management of the third stage of labour is
associated with a substantial reduction in the occurrence of PPH.
Exclusion criteria:
• Pulmonary edema
• Severe cardiovascular disorders
• Hypersensitivity to oxytocin.
• Epilepsy
• Renal or hepatic disorder ( risk benefit ratio can be assessed).
• Coagulopathy.
• All contraindications of vaginal delivery.
All selected women will be subjected to detailed history taking, and complete
General and Obstetrics examination and routine investigations. Vaginal
examination will be done under strict aseptic precautions.
After careful selection, the women undergoing vaginal delivery will be randomly
divided into 2 groups by simple Randomization.
Study Group A: Inj. Carbetocin 100 micrograms I.M/I.V given
Control Group B: Inj. Oxytocin 10 I.U I.M given
Either of the drugs will be administered within one minute of delivery of the
baby, In case of twin pregnancy the drugs will be given after delivery of the
second twin.
ESTIMATION OF BLOOD LOSS – Once the umbilical cord would be clamped
and cut, Volumetric and gravimetric estimation of blood loss would be
calculated. Volumetric estimation in CHATTISGARH – Drape (CG -Drape).
will be added to gravimetric blood loss. The gravimetric assessment will be done
by weighing the dressing pads with an electric scale before and after being used
to wipe blood during episiotomy repair ,difference of each gram will be taken as
one ml .Blood loss will be measured for atleast one hour but if bleeding continued
after one hour ,until active bleeding has stopped. Study would be aborted if
patient lands in PPH and PPH will be managed according to institutional protocol.
All participants would be followed up for 24 hr. The uterine tone and amount of
bleeding would be noted
Vitals (Pulse ,BP, SpO2,Bleeding per vaginum) and Uterine tone will be
monitored immediately after delivery, 30 and 60min after delivery. Possible
complications like nausea, vomiting, tachycardia, flushing, dizziness, headache,
shivering, metallic taste, dyspnea, palpitation and itching.
Data will be statistically described in terms of mean±standard deviation (±SD),
or frequencies (number of cases) and percentages when appropriate. Comparison
of numerical variables between the study groups will be done using independent
t-test. For comparing categorical data, Chi square test will be performed.
Study group:
Case number:
OPD/Registration number:
• Name:
• Age:
• Sex:
• Address:
• Date:
• Weight:
• Height:
• BMI:
• Chief complaints:
• Personal history
• Obstetrical history:
1. LMP:
2. EDD:
3. POG/S:
4. POG/D:
5. Gravida, parity ,live issue,abortion(GPLA):
• Past history:
• Personal history:
1. occupation:
2. addiction:
3. dietary history:
Examination:
1. general condition:
2. pulse rate:
3. blood pressure:
4. respiratory rate:
5. temperature:
6. pallor:
7. icterus:
8. cyanosis:
9. clubbing:
10. lymphadenopathy:
11. edema:
Systemic examination:
1. CNS:
2. CVS:
Per abdominal examination:
1. Fundal height.
2. Lie.
3. Presentation.
4. FHS.
5. Uterine contraction.
1. STUDY TITLE:
2. STUDY INVESTIGATORS:
3. Student: (Name, Department)
4. Guide (Name, Department):
5. Co- Guide/s (Name, Department):
6. Introduction:
[Provide a simple background about the research topic in non-technical
language from perspective of participant such as: We are conducting a research
study to
………………………………………………………………………………in
SNMC Agra . We would like to …………….……...
……………………………………………………….. If you agree to take part
voluntarily, we will ask you to sign a consent form.]
7. Purpose of the study:
[Write the main aim / objective of study and why is it being done in simple
language such as: The aim of our study is
to…………………...…………………………………….............. This will help
us find..……………………………………………………………………… ]
8. Taking part – what it involves:
a. Do I have to take part?
Participation in this research is entirely voluntary. A decision to not take part, or
to withdraw at any time, will not affect your rights or medical care in any way.
b. What is expected of me if I take part?
If you participate, we
will.……………………………………………………………………… [either
collect information about……………………………(in case of observational
studies) or give you / administer …………………………………………(in
case of interventional studies) or collect sample of
……………………………………………. (in case of diagnostic purposes).]
c. How long will my part in the study last?
Your participation in the study would last for …………….(Mention duration,
whether it is one time, or multiple visits – mention follow-up time points)
d. Do I have to come for extra visits or undergo extra investigations for the
study?
[Include point if applicable to your study. Mention no additional visits or extra
investigations in case of observational studies, or specify non-routine visits or
investigations.]
e. What are the possible benefits in taking part?
[Outline any direct or indirect benefits such as: Taking part will help gain
knowledge about…………………………..which may result in improvement of
management / outcomes for you / patients like yourself (modify according to
your study)]
f. What are the possible disadvantages and risks of taking part?
[In case of observational study: There are no major foreseeable disadvantages or
risks because of the study. There may be risk of loss of privacy and
confidentiality of information collected even though all possible measures will
be taken to ensure safe data storage and access. (In case of interventional study:
mention any specific risks / adverse effects associated with intervention being
studied)]
g. What happens to the information collected from me?
All information collected will be kept strictly confidential and not shared with
anyone. Results from the study will be reported as group data and will not
identify you in any way.
h. What if I change my mind regarding participation in the study?
You are entitled to change your mind and withdraw at any time during the study
without any disadvantage or penalty.
i. Whom do I contact for more information or if I have further questions or
concerns?
If you want any information or have questions or concerns, you can contact:
or
Thumb impression
In case of illiterate sign of witness