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Completed

NCT Number: NCT01869556

Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress

Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.

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Key information

Age range

14 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

The objective of the investigators study is to compare the efficacy of intravenous ergonovine and intramuscular carboprost, when administered with oxytocin infusion, prophylactically to decrease blood loss at Cesarean section for labor arrest. Desensitization of the oxytocin receptors has been recently demonstrated in cultured human myometrial cells after continuous and prolonged exposure to oxytocin in-vitro. This could be also the reason for a greater risk of uterine atony and postpartum hemorrhage (PPH) seen in women requiring induction and augmentation of labor. Therefore, addition of a different uterotonic agent, involving a different mechanism of action, to oxytocin infusion is likely to be beneficial, especially in women undergoing CS following failure to progress in labor, who are at a greater risk for PPH.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients who give written informed consent
  • patients undergoing Cesarean section for failure to progress in labour, under regional anesthesia
  • patients should be in the first stage of labour and have received oxytocin for at least 4 hours

Exclusion criteria

  • patients who refuse to give written informed consent
  • patients who require general anesthesia
  • patients who claim allergy or hypersensitivity to oxytocin, ergot derivatives or prostaglandins
  • patients with cardiac diseases and hypertension or preeclampsia ( diastolic blood pressure > 90 mmHg, systolic blood pressure > 140 mmHg )
  • patients with asthma or any other respiratory disease
  • patients with conditions at risk of PPH such as placenta previa, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, bleeding diathesis and known infection.

Treatment and study plan

Oxytocin

Drug

Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours

Other names: syntocinon

Ergot

Drug

Ergot 0.25mg IV

Other names: ergonovine maleate

Carboprost

Drug

Carboprost 0.25mg IM

Other names: Hemabate®

Primary outcomes

  1. Need for additional uterotonics intraoperatively

    Time frame: 1 hour

    Need for additional uterotonics intraoperatively if requested by the surgeon, YES or NO

Secondary outcomes

  1. Effectiveness of uterine contraction

    Time frame: 10 min

    Adequate/inadequate uterine tone at 3,5 & 10 min

  2. Need for blood transfusion

    Time frame: 24 hours

    Any blood products administered

  3. Vital signs

    Time frame: 2 hours

    In the OR, heart rate, blood pressure, and oxygen saturation will be measured and looked at for abnormalities

  4. Side effects

    Time frame: 24 hours

    The presence of nausea, vomiting,other dysrhythmias, chest pain, headache, bronchospasm and any others will be recorded.

  5. Estimated blood loss

    Time frame: 48 hours

    calculated blood loss = EBV (Pre-op Htc-Post-op Htc) EBV (estimated blood volume, mL)=patient's weight in kg x 85

  6. Need for additional uterotonics or interventions post-operatively

    Time frame: 24 hours

    Need for additional uterotonics or interventions post-operatively up to 24 hours post-partum

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Comparison of Intravenous Ergonovine With Intramuscular Carboprost, Both in Combination With Oxytocin Infusion, During Cesarean Section for Failure to Progress in Labor: A Double-blinded Placebo-controlled Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2013
Registry last updated
Sep 24, 2020

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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