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Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT03870503
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:
The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: oxytocin Drug: oxytocin plus misoprostol Drug: Carbetocin Not Applicable

Detailed Description:

The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.

Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a prospective double-blind randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This study will be a prospective double-blind randomized study
Primary Purpose: Treatment
Official Title: Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: oxytocin
The patient will be received oxytocin 20 IU by intravenous infusion
Drug: oxytocin
The patient will be received oxytocin 20 IU by intravenous infusion
Other Name: Active comparator

Active Comparator: oxytocin plus misoprostol
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol
Drug: oxytocin
The patient will be received oxytocin 20 IU by intravenous infusion
Other Name: Active comparator

Drug: oxytocin plus misoprostol
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
Other Name: Active Comparator

Active Comparator: Carbetocin
The patient will be received Carbetocin 100 mic gm IV
Drug: Carbetocin
The patient received Carbetocin 100 mic gm
Other Name: Active Comparator




Primary Outcome Measures :
  1. The amount of blood loss [ Time Frame: 6 hours post delivery ]
    calculation of the amount of blood loss by weighing the swabs and using pictorial charts


Secondary Outcome Measures :
  1. The number of patients develop blood loss more than 1000 ml [ Time Frame: 24 hours post delivery ]
    Calculation of the number of patients develop blood loss more than 1000 ml

  2. The number of patient need blood transfusion [ Time Frame: 24 hours post delivery ]
    Calculation of number of patient need blood transfusion



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation

Exclusion Criteria:

  • gestational age<37 weeks,
  • genital tract trauma,
  • coagulation defect,
  • women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
  • known hypersensitivity to carbetocin or oxytocin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870503


Contacts
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Contact: hany f allam, md 0102236052 ext 002 hany.farouk@aswu.edu.eg
Contact: nahla w shady, md 01092440504 ext 002 nahla.elsayed@aswu.edu.eg

Locations
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Egypt
Aswan University Hospital Recruiting
Aswan, Egypt, 81528
Contact: Hany F Sallam, MD    0122336052 ext 002    hany.farouk@aswu.edu.eg   
Contact: Nahla W Shady, MD    01092440504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f allam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03870503     History of Changes
Other Study ID Numbers: aswu/201/19
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:
Postpartum Hemorrhage
vaginal delivery
carbetocin
misoprostol
oxytocin

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Misoprostol
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents