CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Carbetocin

Misoprostol

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel > 10 gm/dl

• Noncomplicated pregnancy

Exclusion Criteria:

Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum hemorrhage

Sites / Locations

Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CARBETOCIN

MISOPROSTOL

Arm Description

received 1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby.

received 4 rectal misoprostol tablets (800 μg) after the delivery of the baby.

Outcomes

Primary Outcome Measures

prevention of post partum hemorrhage after vaginal delivery

Number of participants experienced postpartum hemorrhage

Secondary Outcome Measures

drugs side effects

Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching

Full Information

NCT ID

NCT03556852

First Posted

June 4, 2018

Last Updated

October 10, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03556852

Brief Title

CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE

Official Title

CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

July 2, 2018 (Actual)

Primary Completion Date

May 24, 2019 (Actual)

Study Completion Date

May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery

Detailed Description

150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CARBETOCIN

Arm Type

Active Comparator

Arm Description

received 1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby.

Arm Title

MISOPROSTOL

Arm Type

Active Comparator

Arm Description

received 4 rectal misoprostol tablets (800 μg) after the delivery of the baby.

Intervention Type

Drug

Intervention Name(s)

Carbetocin

Intervention Description

1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Intervention Description

2 rectal misoprostol tablets (800 μg) after the delivery of the baby.

Primary Outcome Measure Information:

Title

prevention of post partum hemorrhage after vaginal delivery

Description

Number of participants experienced postpartum hemorrhage

Time Frame

24 hours after delivery

Secondary Outcome Measure Information:

Title

drugs side effects

Description

Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching

Time Frame

24 hours after delivery

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel > 10 gm/dl • Noncomplicated pregnancy Exclusion Criteria: Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum hemorrhage

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Maged

Organizational Affiliation

professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kasr Alainy medical school

City

Cairo

ZIP/Postal Code

12111

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31736069

Citation

Maged AM, Waly M, Fahmy RM, Dieb AS, Essam A, Salah NM, Hussein EA, Nabil H. Carbetocin versus rectal misoprostol for management of third stage of labor among women with low risk of postpartum hemorrhage. Int J Gynaecol Obstet. 2020 Feb;148(2):238-242. doi: 10.1002/ijgo.13056. Epub 2019 Dec 2.

Results Reference

derived

Postpartum Hemorrhage

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial