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Completed

NCT Number: NCT02053922

The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or more.
  • Gestational age of pregnancy of 37 completed weeks or more.
  • Written and signed informed consent by the patient to participate in the study.

Exclusion criteria

  • fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.
  • Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.
  • Women planned to have any other type of uterine incision other than transverse lower segment.
  • Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .
  • Women with placental abruption are excluded because there is a higher risk of hemorrhage with this condition and it was therefore felt to be inappropriate to recruit these women.
  • Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.
  • Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).
  • Women with history of hypersensitivity to oxytocin or carbetocin.
  • Women with any severe allergic condition or severe asthma.
  • Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.
  • Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Treatment and study plan

Syntocinon

Drug

Syntocinon ampoules (10 IU Oxytocin). (Novartis Pharma, Egypt) One ampoule 10 IU diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS, followed by an intravenous drip of 20 IU oxytocin in 500 ml saline over 4 hours.

Carbetocin

Drug

Carbetocin (Ampoule 100 μg/ml) . [Pabal, Marketing Authorization Holder: Ferring GmbH (Gesellschaft mit beschränkter Haftung), Kiel ,Germany. Manufactured by DRAXIS Pharma , a division of specialty Pharmaceuticals Inc. Montreal ,Canada] ,diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS.

Other names: Pabal

Misoprostol

Drug

Misoprostol (200 mcg Tablet) [Misotac, Sigma Pharmaceutical Industries, SAE, Egypt] Two tablets (400 mcg) in the buccal space just after delivery of the neonate during CS.

Other names: Misotac

Primary outcomes

  1. To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section

    Time frame: an expected average 1 week

Secondary outcomes

  1. Adverse events recorded during the study.

    Time frame: an expected average 1 week

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2014
Registry last updated
Feb 6, 2014

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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