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OpenTrials
Completed

NCT Number: NCT04089176

Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH

Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section

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Key information

Conditions

Postpartum Hemorrhage Cesarean Section Female Urogenital Diseases and Pregnancy Complications Hemorrhage High Risk Pregnancy Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

About this study

Randomized controlled clinical trial. Defined patient in two group. Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • previous history of postpartum hemorrhage
  • polyhydramnios
  • fetal macrosomia
  • previous cesarean section
  • grand multiparity
  • intramural myoma
  • chorioamnionitis
  • prolonged premature rupture of membrane
  • augmentation of labour

Exclusion criteria

  • pregnancy induce hypertension
  • on anticoagulant
  • placenta previa or placenta percreta

Treatment and study plan

Carbetocin

Drug

carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min

Oxytocin

Drug

oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr

Primary outcomes

  1. Additional drug use

    Time frame: during intra-operation

    Number of additional drug use after intervention drug

Secondary outcomes

  1. Estimate blood loss

    Time frame: During intra-opeartion and acute post operation period as 24 hours post operation

    amount of blood loss

  2. Side effect

    Time frame: During intra-opeartion and acute post operation period as 24 hours post operation

    type of side effect

  3. Hemoglobin level

    Time frame: Pre-operation and 24 hours post operation

    differentiation of hemoglobin

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2019
Registry last updated
Sep 13, 2019

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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