NCT02306733

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

2.9 years

First QC Date

November 30, 2014

Last Update Submit

January 20, 2017

Conditions

Post Partum Hemorrhage

Keywords

Post partum hemorrhageErgometrineOxytocinObstetrics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Development of major PPH

    10 minutes after giving the drug.

Study Arms (2)

Ergometrine

ACTIVE COMPARATOR

100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv)

Drug: Ergometrine

Oxytocin

ACTIVE COMPARATOR

100 women with atonic PPH will receive oxytocin 10 IU (Syntocinon® Novartis, Switzerland) slowly intravenous.

Drug: Oxytocin

Interventions

ErgometrineDRUG

100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv).

Ergometrine
OxytocinDRUG

100 women with atonic PPH will receive Oxytocin 10 IU(Syntocinon® Novartis, Switzerland) slowly intravenous. iv and group 2 will receive oxytocin

Oxytocin

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Atonic PPH

You may not qualify if:

  • Gestational age\<37 weeks
  • Hypertension, cardiac disease or preeclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BeniSuef University hospitals

BeniSuef, Egypt

RECRUITING

Cairo university hospitals

Cairo, Egypt

RECRUITING

Related Publications (4)

  • 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. doi: 10.1111/j.1471-0528.2007.01377.x.

    PMID: 17567419BACKGROUND

  • 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. eCollection 2014 Nov.

    PMID: 25369200BACKGROUND

  • 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. Epub 2013 Oct 5.

    PMID: 24365208BACKGROUND

  • Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.

    PMID: 33232518DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

ErgonovineOxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

AbdelGany MA Hassan, MRCOG, MD

CONTACT

00201017801604abdelgany2@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

November 30, 2014

First Posted

December 3, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

EG(2)