Effect of Single Dose Antenatal Betamethasone on Neonatal Respiratory Morbidity After Elective Cesarean

NCT ID: NCT04407975

Last Updated: 2020-06-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-29

Study Completion Date

2021-05-31

Brief Summary

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Patients undergoing elective C-section will be randomized into two groups. The first group will receive one dose of Betamethasone at least 24 hours before scheduled C-section. The second group will receive placebo.

Detailed Description

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This is a prospective double blinded randomized clinical trial. Patients will be randomized into two groups. Group A will receive one dose of Betamethasone at least 24 hours before scheduled C-section. Group B will receive placebo. The maternal and neonatal outcomes will be studied in order to assess the effect of Betamethasone on respiratory morbidity of the newborn infant.

Conditions

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Respiratory Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Betamethasone

Patients will receive 14 mg (2 ml) intramuscular betamethasone

Group Type EXPERIMENTAL

Betamethasone

Intervention Type OTHER

A single injection will be administered to the patient at least 24 hours before undergoing C-section. This injection will be prepared in the hospital's pharmacy to contain betamethasone

Placebo

Patients will receive an equivalent volume of normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.

Interventions

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Betamethasone

A single injection will be administered to the patient at least 24 hours before undergoing C-section. This injection will be prepared in the hospital's pharmacy to contain betamethasone

Intervention Type OTHER

Placebo

A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women with singleton or multiple gestation,
* between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period)

Exclusion Criteria

* any medical problem that could affect fetal well-being;
* evidence of intrauterine infection,
* oligohydramnios,
* fetal congenital malformations,
* preeclampsia,
* maternal hypertension,
* severe fetal rhesus sensitization,
* antepartum hemorrhage,
* Intrauterine growth restriction
* preterm rupture of membranes
* preterm delivery
* previously received antenatal steroids less than one month ago
* those who decline to participate in the study.
Minimum Eligible Age

17 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Makassed General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Manal Hubeish

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Hubeish, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

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Makassed General Hospital

Beirut, , Lebanon

Site Status RECRUITING

Countries

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Lebanon

Central Contacts

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Manal Hubeish, MD

Role: CONTACT

+9611636297

Facility Contacts

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Manal Hubesih, MD

Role: primary

+9611636000 ext. 6297

Other Identifiers

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642020

Identifier Type: -

Identifier Source: org_study_id

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