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Completed

NCT Number: NCT01726478

Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital

The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.

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Key information

Conditions

Adverse Effect of Oxytocic Drugs Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Inappropriate Dose of Drug Administered Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mulago Hospital Labour Suite Operating Theatres

Kampala, East Africa, +256, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
  • Age between 18 to 40 years
  • Singleton pregnancies

Exclusion criteria

  • • Allergy to oxytocin
  • Ruptured uterus
  • Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,)
  • Known risk factors for postpartum haemorrhage or uterine atony
  • Inherited or acquired coagulation disorder
  • History of post partum haemorrhage

Treatment and study plan

2.5 units Oxytocin

Drug

Administration of 2.5 units of oxytocin after clamping of umbilical cord

Other names: pitocin

10 units Oxytocin

Drug

Administration of 10 units of oxytocin after clamping of umbilical cord

Other names: pitocin

Primary outcomes

  1. Uterine tone adequacy

    Time frame: 2 minutes

    The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose

Secondary outcomes

  1. Intraoperative blood loss

    Time frame: 24 hours

    Blood loss was estimated by measuring the amount in the suction bottles and weighing of the mops. The patients were followed up for any occurrence of postpartum haemorrhage for the next 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

Faculty of Medicine

Other

Registry information

Official study title

Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 15, 2012
Registry last updated
Nov 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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