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Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally

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ClinicalTrials.gov Identifier: NCT02306733
Recruitment Status : Unknown
Verified January 2017 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : December 3, 2014
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Tracking Information
First Submitted Date  ICMJE November 30, 2014
First Posted Date  ICMJE December 3, 2014
Last Update Posted Date January 23, 2017
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
Need for other uterotonics [ Time Frame: 2 minutes after giving the drug ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02306733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
Development of major PPH [ Time Frame: 10 minutes after giving the drug. ]
Swaps will be weighed and pictorial charts will be used to estimate the amount of bleeding. Major PPH will be defined as bleeding >100ml.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally
Official Title  ICMJE Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial
Brief Summary 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.
Detailed Description

Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.

Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.

Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections. Despite decades of empirical use in clinical practice, there are no trials comparing ergometrine and oxytocin as first-line agents for the treatment (rather than prevention) of PPH.

The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients attending the labour ward will be invited to participate in the study, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study.

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.

Once atonic PPH is diagnosed, 2 14-gauge cannulas will be inserted and a crystalloid intravenous (iv) infusion will be started. The allocated drug will be diluted in 10ml saline and will be given slowly iv, the fundus will be rubbed, A Foley's catheter will be inserted and a fluid balance chart will be commenced, pulse and blood pressure will be recorded every 15 minutes, venepuncture will be done for cross matching 4 units of blood, full blood count and coagulation screen.

The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug. Blood loss will be estimated through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24 hours after delivery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post Partum Hemorrhage
Intervention  ICMJE
  • Drug: Ergometrine
    100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv).
  • Drug: Oxytocin
    100 women with atonic PPH will receive Oxytocin 10 IU(Syntocinon® Novartis, Switzerland) slowly intravenous. iv and group 2 will receive oxytocin
Study Arms  ICMJE
  • Active Comparator: Ergometrine
    100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv)
    Intervention: Drug: Ergometrine
  • Active Comparator: Oxytocin
    100 women with atonic PPH will receive oxytocin 10 IU (Syntocinon® Novartis, Switzerland) slowly intravenous.
    Intervention: Drug: Oxytocin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 2, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Atonic PPH

Exclusion Criteria:

  • Gestational age<37 weeks
  • Hypertension, cardiac disease or preeclampsia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02306733
Other Study ID Numbers  ICMJE PPH 4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbdelGany Hassan, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP