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Uterotonics for Severe Preeclampsia

Primary Purpose

Preeclampsia Severe

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Carbetocin

Oxytocin

Misoprostol

About this trial

This is an interventional prevention trial for Preeclampsia Severe

Eligibility Criteria

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Inclusion Criteria:

Pregnant women which diagnosed with severe pre-eclampsia.
Singleton pregnancy.
Termination of pregnancy by Cesarean section after 28 weeks of gestation.

Exclusion Criteria:

Suspected or proven placental abruption.
Known placenta Previa or acreata.
Multiple pregnancies.
Obesity (BMI >35).
Anemia (<9 g/dl).
Retained placental tissues.
Big baby (> 4 kg).
Presence of coagulopathy.
Polyhydramnios.
Presence of Uterine fibroids.
Medical diseases as; cardiac, liver, renal or endocrine diseases.
General anesthesia.

Sites / Locations

Assiut Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbetocin

Oxytocin plus misoprostol

Arm Description

Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.

Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.

Outcomes

Primary Outcome Measures

The rate of postpartum hemorrhage more than 1000 ml

the amount of bleeding during and after CS

Secondary Outcome Measures

Full Information

NCT ID

NCT04756661

First Posted

February 12, 2021

Last Updated

February 12, 2021

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04756661

Brief Title

Uterotonics for Severe Preeclampsia

Official Title

Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

February 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia

6. Conditions and Keywords

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

Preeclampsia Severe

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carbetocin

Arm Type

Experimental

Arm Description

Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.

Arm Title

Oxytocin plus misoprostol

Arm Type

Active Comparator

Arm Description

Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.

Intervention Type

Drug

Intervention Name(s)

Carbetocin

Intervention Description

100 mcg of Carbetocin intravenous injection

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Intervention Description

10 IU oxytocin IV drip

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Intervention Description

400 mcg rectal

Primary Outcome Measure Information:

Title

The rate of postpartum hemorrhage more than 1000 ml

Description

the amount of bleeding during and after CS

Time Frame

30 minutes

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant women which diagnosed with severe pre-eclampsia. Singleton pregnancy. Termination of pregnancy by Cesarean section after 28 weeks of gestation. Exclusion Criteria: Suspected or proven placental abruption. Known placenta Previa or acreata. Multiple pregnancies. Obesity (BMI >35). Anemia (<9 g/dl). Retained placental tissues. Big baby (> 4 kg). Presence of coagulopathy. Polyhydramnios. Presence of Uterine fibroids. Medical diseases as; cardiac, liver, renal or endocrine diseases. General anesthesia.

Facility Information:

Facility Name

Assiut Faculty of Medicine

City

Assiut

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Uterotonics for Severe Preeclampsia

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