Uterotonics for Severe Preeclampsia

NCT ID: NCT04756661

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-02-10

Brief Summary

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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

Detailed Description

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Conditions

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Preeclampsia Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Carbetocin

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

Group Type EXPERIMENTAL

Carbetocin

Intervention Type DRUG

100 mcg of Carbetocin intravenous injection

Oxytocin plus misoprostol

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

10 IU oxytocin IV drip

Misoprostol

Intervention Type DRUG

400 mcg rectal

Interventions

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Carbetocin

100 mcg of Carbetocin intravenous injection

Intervention Type DRUG

Oxytocin

10 IU oxytocin IV drip

Intervention Type DRUG

Misoprostol

400 mcg rectal

Intervention Type DRUG

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CARBOXMISO

Identifier Type: -

Identifier Source: org_study_id

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