Postpartum Haemorrhage Clinical Trial
Post-partum haemorrhage is one of the life threatening emergencies. It accounts for nearly one-quarter of all maternal death worldwide. Atonic uterus contributes about 80% among the causes. Uterotonic drugs are administered following the delivery of baby both in vaginal and caesarean delivery for prevention of PPH. However postpartum haemorrhage cannot always be prevented. But, the incidence and especially its magnitude can be reduced by assessing the risk factors and following the guidelines. The intelligent anticipation, skilled supervision, prompt detection and effective institution of therapy can prevent a normal case from undergoing disastrous consequences. This study will be carried out at Bangabandhu Sheikh Mujib Medical University (BSMMU) within six months after approval. This is a Randomized Control Trial which will compare efficacy of Carbetocin and Oxytocin for the control of PPH. Structured Questionnaire, Data Sheet, hospital indoor documents i.e. Patient chart, operation notes, surgeons visual estimation of blood loss etc will be used as study tool. Ethical clearance will be obtained from Institutional Review Board of BSMMU. Written informed consent will be obtained from the patient or from her legal guardian. Patient confidentiality will be strictly maintained. No name, address or contact details of the patient will be divulged.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | November 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patient with risk factors for primary post-partum haemorrhage such as: multiple pregnancy, one or more previous caesarean section, presence of uterine fibroids, previous myomectomy, presence of placenta previa, past history of PPH, fetal macrosomia and fetal malformations associated with polyhydramnios Exclusion Criteria: - Presence of hypertension, eclampsia, cardiac, renal or liver diseases, epilepsy, general anaesthesia, as well as women with history of hypersensitivity to Carbetocin according to the Br National Formulary. Patients unwilling to give consent for this study are also excluded |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Bangladesh | BSMMU | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimated blood loss after cesarean section | 24 hours of delivery | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02509351 -
Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?
|
Phase 2/Phase 3 | |
Completed |
NCT01931423 -
The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study
|
N/A | |
Completed |
NCT00499005 -
Carbetocin Versus Syntometrine for the Third Stage of Labour
|
Phase 4 | |
Completed |
NCT01485562 -
Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
|
N/A | |
Completed |
NCT01359878 -
Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial
|
Phase 2/Phase 3 | |
Completed |
NCT00872469 -
World Maternal Antifibrinolytic Trial
|
Phase 3 | |
Completed |
NCT02704780 -
Two Different Regimens of Misoprostol in Retained Placenta
|
Phase 2 | |
Completed |
NCT01895218 -
Treatment of Women After Postpartum Haemorrhage
|
Phase 3 | |
Completed |
NCT01931410 -
The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial
|
Phase 4 | |
Recruiting |
NCT02187874 -
Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
|
N/A | |
Withdrawn |
NCT01910675 -
PCC and Fibrinogen Compared With FFP in PPH
|
Phase 4 | |
Completed |
NCT02562300 -
Uterotonics Using to Reduce Bleeding at Cesarean Section
|
Phase 2 | |
Completed |
NCT01044082 -
Prevention of Post-partum Haemorrhage
|
N/A | |
Completed |
NCT01116050 -
Intrarectal Misoprostol in Postpartum Haemorrhage
|
Phase 3 | |
Completed |
NCT02149472 -
Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
|
||
Recruiting |
NCT02492087 -
Topical Tranexamic Acid in Caesarean Section
|
Phase 3 | |
Completed |
NCT02468310 -
Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana
|
N/A | |
Recruiting |
NCT02136719 -
Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
|
N/A |