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

Carbetocin Versus Misoprostol for Prevention of Postpartum Hemorrhage in Pregnant Women at High Risk Following C.S.

We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.

Study Overview

• Status: Unknown
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Misoprostol; Drug: Carbetocin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Beni-Suef University
    • Principal Investigator: Nesreen A Shehata, Lecturer
    • Sub-Investigator: Abdelgany M Hassan, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: 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.	Drug: Misoprostol; 600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.; Other Names: Misotac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine tone and size	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.	One hour after the cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	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.	One hour after cesarean section

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin concentration	Changes in hemoglobin concentrations before and 24 hours postoperative. Using a 10% fall in hematocrit value to define post-partum hemorrhage.	Before and 24 hours after the operation

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Cairo University
• Investigators: Principal Investigator: Nesreen A Shehata, MD, Beni-Suef University

Publications and helpful links

Helpful Links

• • 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,
• 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
• 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.
• • 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: October 26, 2014
• First Submitted That Met QC Criteria: October 26, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: PPH
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Carbetocin
• Other Study ID Numbers: Beni-Suef 7