RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATE AND ADDRESS (in Block Letters) / Dr. PADMAVATHI RAVIPATID/O RAMAKRISHNA RAVIPATI
35, KHB COLONY, PARVATHI NAGAR, BELLARY,KARNATAKA.
2. / NAME OF THE INSTITUTION / JJM MEDICAL COLLEGE
DAVANGERE-577004
3. / COURSE OF STUDY AND SUBJECT / MEDICAL
M.S. IN OBSTETRICS AND GYNAECOLOGY
4. / DATE OF ADMISSION TO COURSE / 02.06.2012
5 / TITLE OF THE TOPIC / “COMPARATIVE STUDY BETWEEN INTRAUMBILICAL VEIN INJECTION OF 20IU OXYTOCIN WITH NORMAL SALINE WITH ACTIVE MANAGEMENT OF THIRD STAGE LABOUR”
6. / BRIFF RESUME OF INTENDED WORK:
6.1 NEED FOR THE STUDY:
During the first hours that follow the birth of a neonate (third and fourth stage of labour), complications are common and can threaten the mother’s life. The most common complication is postpartum hemorrhage, which remains a leading cause of maternal mortality (25.0%) especially in developing countries1. In developed countries, 3-5% of deliveries are complicated by postpartum hemorrhage; in developing countries, it is 50 times more common2. Retained placenta is another complication of the third stage of labour. It occurs in 0.1-2% of deliveries3 and is associated with a high risk of hemorrhage. At present, treatment is by manual removal of the placenta, which requires an operating room, a surgeon, and an anesthetist, facilities that are often unavailable to women in resource-poor setting. As a result, this condition has a case fatality rate of nearly 10% in rural communities3.
The length of the third stage of labour and the possibility of associated complications depend on a combination of the ability of the uterine muscle to contract and the length of time it takes for placental separation. The principle management of third stage of labour is aimed at reducing the time of delivery of the placenta, thereby minimizing serious adverse effects such as blood loss and retained placenta. Active management of the third stage of labour, which includes prophylactic injection of 10 international units oxytocin within 2 minutes of birth, early clamping of the umbilical cord, and controlled cord traction, is recommended by the World Health Organization for postpartum hemorrhage prevention4.
Umbilical vein oxytocin injection directs treatment to placental bed and uterine wall, resulting in earlier uterine contraction and placental separation.5
The present study is aimed at studying the effectiveness of intraumbilical vein oxytocin injection in reducing blood loss during the third and fourth stages of labour, the duration of the third stage of labour and the incidence of manual removal of retained placenta. If the present study justifies the use of intra-umbilical oxytocin in third stage of labour, then it is very useful simple, less expensive, non-invasive and acceptable method to reduce incidence of PPH and retained placenta.
6.2 REVIEW OF LITERATURE
1. Fehmida tehseen (et al) (2002) conducted a study on role of intraumbilical vein oxytocin in reducing blood loss during and after 1 hour of delivery of placenta and its efficacy in reducing the frequency of retained placenta. Women who received intraumbilical vein syntocinon had less blood loss compared to the controls who received normal saline alone. Study concluded that addition of intraumbilical vein oxytocin 10 units resulted in marked reduction in amount of blood loss, duration of 3rd stage and incidence of retained placenta in comparison to iv 5IU oxytocin+0.5mg ergometrine alone.
2. Gazvani M.R (et al 1998) evaluated the efficacy of intraumbilical oxytocin as treatment for retained placenta and prevention of PPH. They divided patients into 3 groups
· Group 1- received 20 IU oxytocin in 20 ml saline
· Group 2- received 20ml plain saline
· Group 3- no treatment
Results were there was significant reduction in PPH and a high rate of spontaneous expulsion of placenta compared to other 2 groups. There was no difference between the saline group and no treatment group.
3. RD Athavale (et al 1991) evaluated the efficacy of intraumbilical oxytocin in minimizing the blood loss during 3rd and 4th stage of labour. He divided patients into 3 groups and
· Group 1- received intraumbilical oxytocin 20IU in 20 ml normal saline
· Group 2- intraumbilical normal saline after delivery of baby and methylergometrine at the end of 1st hour or earlier if required.
· Group 3-methylergometrine following delivery of anterior shoulder.
Study concluded that intraumbilical vein oxytocin is very effective and can be used has an alternative where methylergometrine is contraindicated.
4. Weeks AD (et al 2005) conducted a study to know the effectiveness of intraumbilical vein oxytocin for the treatment of retained placenta (RELEASE STUDY) where 50IU of oxytocin in 25ml normal saline was given to study group and controls received normal saline. Study concluded that intraumbilical oxytocin is effective in treatment of retained placenta.
5. Kharkwal S (et al 1998) conducted a study in which they enrolled 100 cases of normal delivery of which 50 cases treated with 5IU of oxytocin in 10CC of normal saline into umbilical vein, a mean injection expulsion interval of 4.23 min and blood loss of 127 ml and the rest 50 cases, 0.2mg methergine IV was given after delivery of head. The mean injection expulsion interval was 8.23min n blood loss was 256ml.
6. Nayak A.H (1993) studied the effectiveness of the intraumbilical oxytocin in shortening the 3rd stage of labour was compared with intraumbilical normal saline injection. Mean duration of 3rd stage in oxytocin group was 5.38 min and average blood loss was 48.2ml while in control group it was 8.2 min and 100.5 ml respectively.
6.3 OBJECTIVE OF THE STUDY
To study the Intraumbilical Vein Injection Of 20iu Oxytocin with comparison with normal saline and its effect of duration of 3rd stage of labour, reduction of Blood Loss and incidence / prevention of retained placenta.
7. / MATERIALS AND METHODS
7.1 Source of data:
Hospitals attached to JJM Medical college:-
· Bapuji hospital, Davangere.
· Chigateri general hospital, Davangere.
· Women and child hospital, Davangere.
Duration of study – September 2012
7.2 Methods of collecting data:
Design – prospective randomised study
No. of cases: 400
Oxytocin group: 200
Normal saline group: 200 as controls.
Inclusion criteria:
· No risk factors for PPH
· Gestational age b/w 37-42 weeks
· Singleton pregnancy
· Live fetus
· Cephalic presentation
· Neonatal birth weight of 2.5-4.5 kg
· Parity b/w one and five
· Maternal age younger than 35yrs
· Vaginal birth
Exclusion criteria:
· Blood pressure 140/90mmHg or greater
· Placenta previa
· Placental abruption
· h/o any bleeding during pregnancy
· h/o curettage
· LSCS / any uterine scar
· h/o any PPH
· hydramnious
· signs and symptoms of maternal infection
· known uterine anomalies
· h/o any drug use during labour
· abnormal placentation(acreta, increta & percreta)
· coagulation defects
· instrumental deliveries
· Hb<8gm/dl
· h/o anticoagulant drugs
· beta mimetic medication during pregnancy
· prolongation of 1st stage of labour longer than 15Hrs
· induced labour
Procedure of study:
Patients are selected according to the inclusion criteria. Patients are divided into study group and control group
Study group will receive 20IU oxytocin diluted with 26ml of saline and the control group will receive 30 ml saline. Medications are given directly in the umbilical vein after clamping, injection given over 1 minute. Observations are made for the following:
Primary outcome:- Amount of blood loss in third and fourth Stage of labor
Other outcomes:- Duration of third stage of labor Percentage of retained placenta
· Need for additional uterotonic drugs
· Side effects at the time of injection(anaphylactic reactions, hypotension, and cardiac arrhythmias)
Amount of blood loss is assessed with:
1. Specially designed drape used at the commencement of 3rd stage of labour till the end of 4th stage and blood loss calculated by weighing the drape before and after the procedure.
Determination of changes in Hb%.
7.3 investigation required
Hb% Only
7.4 Ethical clearance from the institution
Yes
Approval from the ethical committee of J.J.M Medical College, Davangere has been taken. Side effects of the device and drugs will be clearly explained to the patients in the local language and consent will be taken.
8. / LIST OF REFERNCES:
1) Chamberlain GVP. The clinical aspects of massive haemorrhage. In: Patel N, editor. Maternal mortality-the way forward. London (UK): Royal College of Obstetricians and Gynaecologists; 1992. p. 54-62.
2) World Health Organization. The prevention and management of postpartum haemorrhage. Report of a technical working group. Geneva (Switzerland): WHO; 1990.
3) Weeks A. The retained placenta. Best Pract Res Clin Obstet Gynaecol 2008;22:1103-17.
4) World Health Organization. WHO recommendations for the prevention of post partum haemorrhage. Geneva (Switzerland): WHO; 2006.
5) Neri A, Goldman J, Gans B. Intra-umbilical vein injection of Pitocin. A new method in the management of the third stage of labor. Harefuah 1966;70:351-3.
6) Fehmida Tehseen, Ambreen Anwar and Yasir Arfat: intraumbilical veinous injection oxytocin in the active management of third stage of labour. Jr of the college of physicians and surgeons Pakistan 2008, Vol. 18 (9):551-554
7) M.R. Gazvani M.D, M.J.M Luckas, MD, A.J. Drakeley MD, SJ Emery , MD, Z. Alfirevic , MD & S.A. Walkinshaw MD : Intraumbilical oxytocin for the management of retained placenta à A randomized controlled trial , OBG. Vol 91, No. 2 , Feb 1998
8) RD Athavale, NM Nerurkar, SA Dalvi , MS Bharttacharya : Umbilical vein oxytocin in active management of 3rd stage of labour. Journal of post graduate medicine : Yr 1991, Vol 37, Issue . 4 : Page 219-20.
9) Dr. Andrew D. Weeks , : The release Trial : A randomised Trial of umbilical vein oxytocin veruss placebo for the treatment of retained placenta. Lancet 2010; 375: 141-7.
10) S. Kharkwal, M. Kapoor, U. Agarwal, Sunita Singh . Active Management of Third Stage of Labour by oxytocin saline Instillation in the Umbilical vein. The Journal of Obstetrics and Gynaecology of India. 1998; 48(3) : 41.
11) Nayak A.H. Mhatre GM, Dalal AR. 1993 : “Active Management of Third stage of labour with intraumbilical oxytocin” Jr. Obstet & Gynaecol Ind; 43: 214.
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / In our country commonest cause of maternal mortality is bleeding due to 3rd stage of labour. This study is undertaken to know the efficacy of intraumbilical injection of 20IU oxytocin to reduce the amount of blood loss in 3rd stage and reduce incidence of PPH and retained placenta.
11. / NAME & DESIGNATION
11.1 GUIDE
11.2 SIGNATURE / DR. DHARMAREDDY D.B. Prof. & Unit Head Dept of Obstetrics and Gynaecology J.J.M. Medical College, Davangere
11.3 CO-GUIDE (If any)
11.4 SIGNATURE / Dr. BANDAMMA N.S. Professor Dept of Obstetrics and Gynaecology J.J.M. Medical College, Davangere
11.5 HEAD OF THE DEPARTMENT
11.6 SIGNATURE / Dr. T.G. SHASHIDHAR MD, DGO,
Professor & HOD,
Dept of Obstetrics and Gynaecology
J.J.M. Medical College, Davangere
12 / REMARKS OF THE CHAIRMAN AND PRINCIPAL
12.1 SIGNATURE
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