Post Partum Hemorrhage Clinical Trial
Official title:
Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial
NCT number | NCT02306733 |
Other study ID # | PPH 4 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | November 30, 2014 |
Last updated | January 20, 2017 |
Start date | November 2014 |
200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Atonic PPH Exclusion Criteria: - Gestational age<37 weeks - Hypertension, cardiac disease or preeclampsia |
Country | Name | City | State |
---|---|---|---|
Egypt | BeniSuef University hospitals | BeniSuef | |
Egypt | Cairo university hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Atukunda EC, Siedner MJ, Obua C, Mugyenyi GR, Twagirumukiza M, Agaba AG. Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in Uganda: a double-blind randomized non-inferiority trial. PLoS Med. 2014 Nov 4;11(11):e1001752. doi: 10.1371/journal.pmed.1001752. — View Citation
Ezeama CO, Eleje GU, Ezeama NN, Igwegbe AO, Ikechebelu JI, Ugboaja JO, Ezebialu IU, Eke AC. A comparison of prophylactic intramuscular ergometrine and oxytocin for women in the third stage of labor. Int J Gynaecol Obstet. 2014 Jan;124(1):67-71. doi: 10.1016/j.ijgo.2013.07.020. — View Citation
Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for other uterotonics | The uterus will be palpated to check the uterine tone and the amount of the bleeding will be estimated 2 minutes after giving the drug. Bleeding will be estimated by weighing the swaps and using pictorial charts. | 2 minutes after giving the drug | |
Secondary | Development of major PPH | Swaps will be weighed and pictorial charts will be used to estimate the amount of bleeding. Major PPH will be defined as bleeding >100ml. | 10 minutes after giving the drug. |
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