BANGALORE. KARNATAKA.
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS /
DR. RASHMI. NAGANGOUDARU POST GRADUATE STUDENT, DEPARTMENT OF OBSTETRIC AND GYNAECOLOGY,
KIMS, HUBLI.2. / NAME OF THE INSTITUTION /
KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI – 22.
3. / COURSE OF STUDY AND SUBJECT: / M.S. (OBSTETRICS AND GYNAECOLOGY).4. / DATE OF ADMISSION TO COURSE: / 13/05/2009
5. / TITLE OF THE TOPIC: / “TRANEXAMIC ACID FOR THE TREATMENT OF POSTPARTUM HAEMORRHAGE: PLACEBO CONTROLLED STUDY”.
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Each year, world wide about 530,000 women die from causes related to pregnancy and childbirth. Almost all (99%) of the deaths are in low and middle income countries. Obstetric haemorrhage is the leading cause of maternal mortality accounting for between one quarter and one third of deaths, most of which occur in postpartum period. About 14 million mothers develop postpartum haemorrhage each year. And about 2% of them will die, with an average interval from onset to death of about 2-4hrs. Systemic anti-fibrinolytic agents are widely used in surgery to prevent clot breakdown (fibrinolysis) in order to reduce surgical blood loss. This study will provide a reliable scientific basis for recommendations as to whether or not tranexamic acid should be used in the treatment of postpartum haemorrhage. If tranexamic acid reduces mortality in women with postpartum haemorrhage, it could be of considerable significance as global commitment to the Millennium development goal (MDG) of reducing maternal death by three quarters by the year 2015, a commitment that requires a reduction of the maternal mortality ratio by 5.5% each year. Because maternal haemorrhage accounts for over a quarter of deaths, an effective treatment for postpartum haemorrhage would contribute importantly to the MDG of reducing maternal mortality. Tranexamic acid might also reduce the need for hysterectomy, decrease the risk of anaemia and avoid the need for blood transfusion. Blood is scarce resource in many countries with risk of transfusion transmitted infections.
6.2 REVIEW OF LITERATURE:
- Study done by Yang H, Zheng S, Shi C, Dept of OBG, first teaching hospital of Beijing university, Beijing 100034, China. Clinical study on efficacy of tranexamic acid in reducing postpartum blood loss: a randomized, comparative, multicenter trial. This was a prospective study where 400 primipara with term singleton pregnancy, vertex presentation, spontaneous delivery where enrolled. Ten units of Oxytocin was injected intravenously immediately after the delivery of foetal shoulders in the second stage of labour. Then all puerperants were randomly assigned into four groups. Group 1 Transamin 1.0 gm was injected IV; Group 2 Transamin 0.5 gm IV; Group 3 Aminomethyl Benzoic acid 0.5 gm IV was given; Group 4 no treatment. Vaginal bleeding was precisely collected, and examined immediately after the expulsion of placenta and from placenta expulsion till 2 hrs of delivery. The amount of blood loss was measured by both methods of weight and volume. Conclusion: Transamin is efficient and safe in reducing the postpartum blood loss. 1 gm of Transamin has the best efficacy and 0.5 gm Transamin followed.
- Study done by Sekhavat L, Tabatabaii A, Dalili M, Farajkhoda T, Tafti AD, Dept of OBG, ShahidSedughiHospital, ShahidSedughiUniversity of medical Sciences and Health Services, Yazd, Iran. Efficacy of tranexamic acid in reducing blood loss after caesarean section. Prospective randomized study conducted on 90 primipara divided into two groups who underwent caesarean section. The study group, 45 women received tranexamic acid immediately before caesarean section, where as the control group, 45 women received placebo. Blood loss volume was measured from the end of caesarean section to 2 hrs postpartum and compared between the two groups. Haemoglobin and hematocrit were tested 24 hrs after section and compared between the two groups. Conclusion: Tranexamic acid statistically reduces blood loss from end to 2 hrs after caesarean section and its use was not associated with any side effects or complications.
- Study done by Ferrer P, Roberts I, Sydenham E, Blackhall K, Shakur H at Londonschool of Hygiene and Tropical Medicine, Keppel street, London. WC1E 7HT,UK. Antifibrinolytic agents in postpsrtum haemorrhage: a systemic review. Three randomized control trials were identified involving 461 participants. The trials compared Tranexmic acid with no treatment and reported blood loss after delivery. Conclusion: Tranexamic acid may reduce blood loss in postpartum haemorrhage.
- Study done by Ming-Ying Gai, Lian-fang Wu, Qi-feng Su, Karin Tatsumoto, at Dept of OBG of Peking Union Medical College Hospital, ChineseAcademy of Medical Sciences, Beijing 100730, China. A clinical observation of blood loss reduced by Tranexamic acid during and after caesarean section; a multicentre, randomized trial. In the study 180 primiparas were randomized into two groups. The study group 91 women received Tranexamic acid before caesarean section where as the control group, 89 women did not. Conclusion: Tranexamic acid statistically reduces the extent of bleeding from placental delivery to 2 hrs post partum.
- Study done by A C Bolte, L S Bouma and H P van Geijn, Dept of OBG Vrij University Medical Center, Amsterdam, The Netherlands. Medical therapy for primary postpartum haemorrhage. Conclusion: Medical therapies that have been reported to successfully control PPH include administration of Uterotonics, and more recently Tranexamic acid and Recombinant Activated Factor Vll.
- Study done by I A Greer, G D Lowe, J J Walker, C D Forbes, at University Dept of OBG, Center for Reproductive Biology, Edinburgh. Study of haemorrhagic problems in OBG in patients with congenital coagulopathies, retrospective study in which all women in contact with the Unit over a period of 30 yrs, comprising 8 with Von Willebrand disease, 18 obligate carriers of Hemophilia A, 5 obligate carriers of Christmas disease. Hemostatic changes associated with pregnancy and other gynaecological problems were studied. Conclusion: Tranexamic acid can be used in the hemostatic problems associated with pregnancy and other gynaecological problems other than Factor VlllC.
This study will provide reliable evidence as to whether the antifibrinolytic agent Tranexamic acid reduces mortality, hysterectomy and other morbidities in women with clinically diagnosed postpartum haemorrhage.
7. / MATERIALS AND METHODS
7.1SOURCE OF DATA:
Study will be done on 100 adult women with clinically diagnosed postpartum haemorrhage, satisfying inclusion and exclusion criteria, following vaginal delivery of a baby or caesarean section; women may have delivered their babies at KIMS hospital or outside, with hospital admission following delivery. 50 women will receive Tranexamic acid and 50 will receive placebo (Normal Saline).(1gm IV, if after 30 mins bleeding continues, or if it stops and restarts within the 24hrs after the first dose, a second dose may be given. Appox rate of 1 ml/min).
7.2METHODS OF COLLECTION OF DATA:
INCLUSION CRITERIA:
The clinical diagnosis of pph may be based on any of the following.
- Estimated blood loss after vaginal delivery of baby > 500ml OR
- 1000 ml from caesarean section OR
- Estimated blood loss enough to compromise the hemodynamic status of the women.
EXCLUSION CRITERIA:
Women for whom there is clear contraindication for Tranexamic acid should not be enrolled for the study (eg. A known Thromboembolic event during pregnancy).STATISTICAL ANALYSIS
7.3 Does the study require any investigations of interventions to be conductedon the patient or other humans or animals ?
NO,Any investigations are not required to be conducted on patient or animals.
7.4Has ethical clearance been obtained from ethical committee of your institution in case of 7.3 ?
Yes,
Ethical clearance has been obtained from Ethical Committee of KIMS, HUBLI.
8. / LIST OF REFERENCES:
- Clinical study on the efficacy of Tranexamic acid in reducing postpartum blood loss. Zhonghua Fu Chan Ke Za Zhi. 2001 OCT; 36(10):590-2.
- Efficacy of Tranexamic acid in reducing blood loss after caesarean section. J Matern Fetal Neonatal Med. 2009 Jan;22(1):72-75.
- Antifibrinolytic agents in PPH: a systematic review. BMC Pregnancy Childbirth. 2009 July 15;9:29.
- Clinical observation of blood loss reduced by Tranexamic acid during and after caesarean section. European Journal of OBG and Reproductive Biology. Vol 112, issue 2, 10 Feb 2004, page 154-157.
- Medical therapies for primary PPH. International Congress Series, Vol 1279, April 2005, pages 364-368.
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / Obstetric haemorrhage is the leading cause of maternal mortality. This study with Tranexamic acid might help to reduce the maternal mortality, the need for hysterectomy and blood transfusion
11. /
11.1 NAME AND DESIGNATION OF GUIDE
/DR. RAMALINGAPPA. C. ANTARATANI.
MD, DNB.PROF. OF OBG, KIMS HUBLI.
11.2 SIGNATURE
11.3 CO-GUIDE
11.4 SIGNATURE
11.5 HEAD OF THE DEPARTMENT / DR. U S HANGARGA. MD.
PROF AND HOD
KIMS, HUBLI.
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE PRINCIPAL AND CHAIRPERSON
12.2 SIGNATURE