Clinical trial NCT02277067: Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S.
Official title: Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Pregnant Women at High Risk Following C.S.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Keywords: PPH
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2014-10-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.

Detailed description: * Postpartum hemorrhage was traditionally defined as blood loss in excess of 500 mL from a vaginal delivery or 1000 mL at cesarean section. It can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies. (Almog et al, 2011)
* Uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible. Many units of an oxytocin infusion and/or rectal misoprostol during and after cesarean deliveries used to reduce the incidence of atony. -Misoprostol has been widely recommended for the prevention of post-partum hemorrhage when other methods are not available. The most common regimen reported for the treatment of post-partum hemorrhage is rectally. (Oladapo et al., 2012)
* Misoprostol is a prostaglandin E1 analogue. It has been investigated in the prevention of postpartum hemorrhage, using either the oral or rectal route of administration. (Hofmeyr et al, 2009)
* Carbetocin is a long-acting oxytocin studied by Dansereau et al.; 1999.They found that the carbetocin group of patients had a decreased incidence of PPH and of the need for therapeutic oxytocics. The recommended dose of carbetocin is 100 mg given either IM or slowly (over 1 minute).
* Risk factors may present antenatally or intrapartum; care plans must be modified when risk factors present. Clinicians must be aware of risk factors for PPH and should take these into account for the wellbeing and safety of both the mother and the baby.RCOG GUIDLIN Table 1: Risk factors for PPH

  * Suspected or proven placental abruption
  * Known placenta praevia
  * Multiple pregnancy
  * Pre-eclampsia/gestational hypertension
  * Previous PPH .
  * Obesity (BMI \>35)
  * Anaemia (\<9 g/dl)
  * Delivery by elective caesarean section
  * Induction of labour
  * Retained placenta Tissue
  * Prolonged labour (\> 12 hours) .
  * Big baby (\> 4 kg) Royal College of Obstetrics and Gynecology.Green-top Guideline No. 52 May 2009 Minor revisions November 2009 and April 2011. Prevention and Management of Postpartum Hemorrhage. Thus our aim is to compare the effeciency and cost effectiveness of Carbitocin and Misoprostol in patients at high risk of PPH after C.S. in prevention of PPH.

Eligibility criteria: Inclusion Criteria:

* Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.

Any medical disorder with pregnancy that carries a risk factor for PPH.

Exclusion Criteria:

* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation.

Primary outcomes:
measure: Uterine tone and size
timeFrame: One hour after the cesarean section
Secondary outcomes:
measure: Blood loss
timeFrame: One hour after cesarean section
Other outcomes:
measure: Hemoglobin concentration
timeFrame: Before and 24 hours after the operation
Locations:
city: Cairo
country: Egypt
facility: Beni-Suef University
Study officials:
affiliation: Beni-Suef University
name: Nesreen A Shehata, MD
role: PRINCIPAL_INVESTIGATOR
References: