Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S.

NCT ID: NCT02277067

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2021-08-31

Brief Summary

We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients 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).
• 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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Carbetocin

Intervention Type: 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.

Misoprostol

Misoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative.

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.

Interventions

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.

Intervention Type: DRUG

Misoprostol

600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.

Intervention Type: DRUG

Other Intervention Names

Pabal; Misotac

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Nesreen Abdel Fattah Abdullah Shehata

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nesreen A Shehata, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

Beni-Suef University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nesreen A Shehata, MD

Role: CONTACT

nesoomar@yahoo.com

00201227866337

Abdelgany M Hassan, MD

Role: CONTACT

abdelgany2@gmail.com

00201017801604

Related Links

http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=%E2%80%A2%20Almog%20B%2CMalabarey

• Almog B,Malabarey O, Brown R, Abenhaim HA, Shrim A. (2011), Postpartum hemorrhage in low risk population. J Perinat Med. 2011 Sep; 39(5):495-8. Epub 2011 Jun 30. Department of Obstetrics and Gynecology, McGill University Health Center, Montreal, QC,

http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=Oladapo%20et%20al.%2C%202012)

Advance misoprostol distribution for preventing and treating postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Feb 15; 2:CD009336. Maternal and Fetal Health Research Unit, Department of Obstetrics and Gynaecology, Obafemi Awolowo College of Health

http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=Hofmeyr+et+al%2C+2009

Maternal consequences of caesarean section. A retrospective study of intra-operative and postoperative maternal complications of caesarean section during a 10- year period. Eur J Obstet Gynecol Reprod Biol. 2009;74(1):1-6.

http://www.google.com.eg/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=Dansereau+et+al.%3B+1999

• Dansereau J, Joshi AK, Helewa ME, Doran TA, Lange IR, Luther ER, et al. Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section. Am J Obstet Gynecol 1999; 180:670-6.

Other Identifiers

Beni-Suef 7

Identifier Type: -

Identifier Source: org_study_id