Clinical trial NCT02277041: Carbetocin Versus Misoprostol in Cases With Placenta Previa After C.S.
Official title: Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Cases With Placenta Previa After 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 efficacy and safety of Carbetocin with Misoprostol in prevention of postpartum hemorrhage in Placenta previa women 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).
* Placenta previa, placenta accreta, and vasa previa are important causes of bleeding in the second half of pregnancy and in labor. Risk factors for placenta previa include prior cesarean delivery, pregnancy termination, intrauterine surgery, smoking, multifetal gestation, increasing parity, and maternal age. Thus, placenta previa is a risk factor for post partum hemorrhage.2006 Apr;107(4):927-41.

Placenta previa, placenta accreta, and vasa previa. Oyelese Y1, Smulian JC.Obstet Gynecol

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* • Women undergoing caesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.

  * women undergoing caesarean section at less than 37 weeks of gestation.
  * Hypertension with pregnancy.
  * Cardiac and coronary diseases with pregnancy

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
role: PRINCIPAL_INVESTIGATOR
References: