Effect of Pre-delivery Dexamethasone in Comparison With Betamethasone on Fetal Heart Trace

Rawalpindi Medical University

Status and phase: Enrolling; Phase 4

Conditions: Steroids; Cardiotocography

Treatments: Drug: Dexamethasone; Drug: Betamethason Sodium Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT07078786

1080/IREF/RMU/2024

Details and patient eligibility

About

As baby grows inside the womb of mother, heart and other organs develop. The heart activity can be recorded by placing a transducer on the belly of mother. The tracing obtain provides information about heart rate, any increase or decrease in heart rate and how much it varies with time. Variation in heart rate along with increase is indicator of fetal well being. Some mothers are at high risk of pre-term birth that is baby delivery before 37 weeks of gestation. In such cases steroids are given to mother to accelerate lung development of the baby so that it can easily adapt to outside world. Dexamethasone and Betamethasone are commonly used steroids which can also effect fetal heart activity.

Full description

Some patients are at high risk of Pre term birth and therefore they are advised antenatal steroids which facilitates fetal lung development preparing it for smoother transition for extra-uterine life. Dexamethasone and Betamethasone are commonly used for this purpose but differently effect fetal cardiac activity as evident by CTG changes and awareness of these phenomena would prevent iatrogenic delivery of preterm fetuses.

Enrollment: 110 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• History of pre term labor
• Preterm pre labor rupture of membranes
• Third trimester bleeding due to placenta previa

Exclusion criteria

• IUGR
• Uteroplacental insufficiency
• Oligohydroamnios
• Maternal drug therapy that can effect fetal heart rate
• Contraindications to Intramuscular injections
• Patients admitted with non reassuring CTG

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Group Betamethasone

Experimental group

Description:

Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days

Treatment:

Drug: Betamethason Sodium Phosphate

Group Dexmaethasone

Active Comparator group

Description:

24mg of Dexamethasone in two divided doses will be given Intramuscularly over 24 hours apart

Treatment:

Drug: Dexamethasone