DRUG
Carbetocin
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 after delivery of the head in cesarean section.
Status
Unknown
Phase
Phase 4
Enrollment
200
Locations
1
Results
Not posted
Publications
0
Study summary
We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.
* 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.
Interventions
DRUG
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 after delivery of the head in cesarean section.
DRUG
600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.
Timeline
First posted
Oct 28, 2014
Study start
Oct 2014
Primary completion
Aug 2021
Study completion
Aug 2021
Results posted
Not reported
Registry updated
Feb 2, 2021
Outcomes
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.
Eligibility
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.
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Beni-Suef University
Cairo, Egypt
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Alex Ekwueme Federal University Teaching Hospital · Blood Loss, Surgical
Early Phase 1
Not yet recruiting
900
2026-07
Mansoura University · Postpartum Hemorrhage · Uterine Atony
Phase 4
Not yet recruiting
332
2026-06
Sheba Medical Center · Postpartum Hemorrhage · Twin Pregnancy
Phase 4
Recruiting
120
2026-05
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage
Not applicable
Recruiting
32
2026-04
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Post Partum Hemorrhage
Not applicable
Recruiting
160
2026-04
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage (Primary)
Not applicable
Recruiting
120
2026-04
Ankara Etlik City Hospital · Postpartum Hemorrhage \(PPH\)
Not applicable
Completed
300
2026-02
Oslo University Hospital · Pregnancy Complications
Phase 4
Completed
240
2026-02
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.