Clinical Trial: Carbetocin Versus Misoprostol in Cases With Placenta Previa After C.S.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Cases With Placenta Previa After C.S.

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 Summary:

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
Sponsor: Beni-Suef University

Current Primary Outcome: Uterine tone and size [ Time Frame: One hour after the cesarean section ]

The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.


Original Primary Outcome: Same as current

Current Secondary Outcome: Blood loss [ Time Frame: One hour after cesarean section ]

Blood loss will be estimated postoperatively by giving each woman of each group standard 2 dressings (standard weight of dressing is 25 gm) for one hour postoperative and recording weight of blood soaked dressings and volume of lost blood.


Original Secondary Outcome: Same as current

Information By: Beni-Suef University

Dates:
Date Received: October 26, 2014
Date Started: October 2014
Date Completion: March 2016
Last Updated: December 26, 2015
Last Verified: December 2015