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

January 30, 2021 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

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

We will compare efficacy and safety of Carbetocin with Misoprostol in prevention of postpartum hemorrhage in Placenta previa women after C.S.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Beni-Suef University
        • Contact:
          • Nesreen A Shehata, MD
        • Principal Investigator:
          • Nesreen A Shehata, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 38 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.

Exclusion Criteria:

  • • Women undergoing caesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.

    • women undergoing caesarean section at less than 37 weeks of gestation.
    • Hypertension with pregnancy.
    • Cardiac and coronary diseases with pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
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.
One hour after the cesarean section

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and 24 hours after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Collaborators

Cairo University

Investigators

  • Principal Investigator: Nesreen A Shehata, Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beni-Suef 8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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