Carbetocin Versus Misoprostol in Cases With Placenta Previa After C.S. (PPH)
|ClinicalTrials.gov Identifier: NCT02277041|
Recruitment Status : Unknown
Verified November 2018 by Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University.
Recruitment status was: Recruiting
First Posted : October 28, 2014
Last Update Posted : November 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: Carbetocin Drug: Misoprostol||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Cases With Placenta Previa After C.S.|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Active Comparator: Pabal ( carbetocin)
Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head.
Pabal 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
Other Name: Pabal
Active Comparator: Misoprostol
Misoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative.
600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.
Other Name: Misotac
- 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.
- 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.
- Hemoglobin concentration [ Time Frame: Before and 24 hours after the operation ]Changes in hemoglobin concentrations before and 24 hours postoperative. Using a 10% fall in hematocrit value to define post-partum hemorrhage.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277041
|Contact: Nesreen A Shehata, MDemail@example.com|
|Contact: Abdelgany M Hassanfirstname.lastname@example.org|
|Contact: Nesreen A Shehata, MD|
|Contact: Abdelgany M Hassan, MD 00201017801604 email@example.com|
|Principal Investigator: Nesreen A Shehata, Lecturer|
|Principal Investigator:||Nesreen A Shehata||Beni-Suef University|