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Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
carbetocin
Tranexamic acid plus misoprostol
misoprostol
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring carbetocin, tranexamic acid, postpartum hemorrhage, buccal misoprostol

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All women admitted to the reception unit for vaginal delivery
  • women aged (20-35 years) with a singleton pregnancy in a cephalic presentation between 38 and 42 weeks gestation.

Exclusion Criteria:

  • medical disorders such as cardiac, hepatic, renal, neurologic disorders thromboembolic disease, blood disorders, diabetes, gestational hypertension, and pre-eclampsia.

-Women at risk for PPH as grand multipara (parity >5), multiple pregnancies, polyhydramnios, fetal macrosomia, antepartum hemorrhage, prolonged, and obstructed labor were also excluded.-

  • Moreover, we excluded women with a scarred uterus or previous instrumental delivery and those suffering from hypersensitivity to TA.

Sites / Locations

  • Aswan University
  • AswanUH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

carbetocin

Tranexamic acid plus misoprostol

misoprostol

Arm Description

Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute

1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.

600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.

Outcomes

Primary Outcome Measures

difference in the mean blood loss at 4 h postpartum between the three groups
measure blood loss by direct and gravimetric methods

Secondary Outcome Measures

difference in hemoglobin level
hemoglobin level pre delivery and 24 hours post delivery
the need for additional uterotonics
the need of additional oxytocin or misoprostol

Full Information

First Posted
October 13, 2018
Last Updated
August 3, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03708497
Brief Title
Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery
Official Title
The Effect of Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Excessive bleeding at or after childbirth accounts for about half of all the post-partum maternal deaths in developing countries and is the single most important cause of maternal mortality worldwide. Post-partum hemorrhage (PPH) is the major contributor to maternal mortality worldwide representing at least 25% of the maternal deaths annually. Prevention of PPH has become a global aim to reduce maternal mortality. Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 hours of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Misoprostol is effective when given orally, buccal, sublingually, vaginally, or rectally, so it might be used by traditional birth attendants, or self-administered, in cases of home-births occurred without the attendance of health personnel or where women are at most risk for occurrence of severe PPH. So, the current study aims to evaluate the effect of prophylactic oral TA plus buccal misoprostol in the prevention of primary PPH after routine active management of the third stage of labor in women at low risk for uterine atony in comparison with carbetocin and buccal misoprostol alone.
Detailed Description
All women admitted to the reception unit for vaginal delivery were invited to participate in the study. The investigators included women aged (20-35 years) with a singleton pregnancy in a cephalic presentation between 38 and 42 weeks gestation. The participated women have entered the screening phase of the study. This phase included history taking (age, parity, and gestational age) with measurement of weight, temperature, and initial hemoglobin level. The investigators excluded women with medical disorders such as cardiac, hepatic, renal, neurologic disorders thromboembolic disease, blood disorders, diabetes, gestational hypertension, and pre-eclampsia. Women at risk for PPH as grand multipara (parity >5), multiple pregnancies, polyhydramnios, fetal macrosomia, antepartum hemorrhage, prolonged, and obstructed labor were also excluded. Moreover, we excluded women with a scarred uterus or previous instrumental delivery and those suffering from hypersensitivity to TA. women were allocated to one of the three study groups: group I (carbetocin group) received 100 mc carbetocin IV after delivery of the baby, group II (misoprostol group) received 600 mg buccal misoprostol after delivery of the baby, and group III (TA plus misoprostol group) received 1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
carbetocin, tranexamic acid, postpartum hemorrhage, buccal misoprostol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
women were allocated to one of the three study groups: group I (carbetocin group) received 100 mc carbetocin IV after delivery of the baby, group II (misoprostol group) received 600 mg buccal misoprostol after delivery of the baby, and group III (TA plus misoprostol group) received 1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed
Masking
None (Open Label)
Masking Description
open label study
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbetocin
Arm Type
Active Comparator
Arm Description
Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute
Arm Title
Tranexamic acid plus misoprostol
Arm Type
Experimental
Arm Description
1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.
Arm Title
misoprostol
Arm Type
Active Comparator
Arm Description
600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.
Intervention Type
Drug
Intervention Name(s)
carbetocin
Other Intervention Name(s)
Active Comparator
Intervention Description
Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid plus misoprostol
Other Intervention Name(s)
active comparator
Intervention Description
1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.
Intervention Type
Drug
Intervention Name(s)
misoprostol
Other Intervention Name(s)
active comparator
Intervention Description
600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.
Primary Outcome Measure Information:
Title
difference in the mean blood loss at 4 h postpartum between the three groups
Description
measure blood loss by direct and gravimetric methods
Time Frame
4 hours post delivery
Secondary Outcome Measure Information:
Title
difference in hemoglobin level
Description
hemoglobin level pre delivery and 24 hours post delivery
Time Frame
24 hours postdelivery
Title
the need for additional uterotonics
Description
the need of additional oxytocin or misoprostol
Time Frame
ist 24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All women admitted to the reception unit for vaginal delivery were invited to participate in the study
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All women admitted to the reception unit for vaginal delivery women aged (20-35 years) with a singleton pregnancy in a cephalic presentation between 38 and 42 weeks gestation. Exclusion Criteria: medical disorders such as cardiac, hepatic, renal, neurologic disorders thromboembolic disease, blood disorders, diabetes, gestational hypertension, and pre-eclampsia. -Women at risk for PPH as grand multipara (parity >5), multiple pregnancies, polyhydramnios, fetal macrosomia, antepartum hemorrhage, prolonged, and obstructed labor were also excluded.- Moreover, we excluded women with a scarred uterus or previous instrumental delivery and those suffering from hypersensitivity to TA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Facility Name
AswanUH
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery

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