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

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-13

Study Completion Date

2025-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiotocography Steroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will be randomly divided into two groups using computer generated numbers and will be masked to the treatment they receive. The person assessing outcome i.e. fetal cardiotography activity will be masked to the treatment participant received.

Study Groups

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Group Betamethasone

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

Group Type EXPERIMENTAL

Betamethason Sodium Phosphate

Intervention Type DRUG

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

Group Dexmaethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

two doses of 12mg of IM Dexamethasone given 24 hours apart

Interventions

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Betamethason Sodium Phosphate

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

Intervention Type DRUG

Dexamethasone

two doses of 12mg of IM Dexamethasone given 24 hours apart

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes