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UnknownNCT02277041

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

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Beni-Suef University · Academic / Other
Sex
Female
Age
25 Years – 40 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGCarbetocinPabal 100 mcg iv infusion over 1 minute given after delivery of fetal head In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute
DRUGMisoprostol600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.

Timeline

Start date
2014-10-01
Primary completion
2021-04-01
Completion
2021-04-01
First posted
2014-10-28
Last updated
2021-02-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02277041. Inclusion in this directory is not an endorsement.