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

Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07078786
Enrollment
110
Registered
2025-07-22
Start date
2025-07-13
Completion date
2025-10-15
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotocography, Steroids

Keywords

Antenatal Steroids, Fetal Cardiotocography, Risk of Pre-term birth

Brief summary

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.

Detailed 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.

Interventions

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

DRUGDexamethasone

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

Sponsors

Rawalpindi Medical College, Pakistan
CollaboratorOTHER
Rawalpindi Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Mean number of accelerations on fetal cardiotocographyBefore intervention, 2 and 4 days after intervention
Long term heart rate variability on fetal cardiotocographyBefore intervention, 2 and 4 days after intervention

Countries

Pakistan

Contacts

Primary ContactIfra Shafique, MBBS
ifra.shafique1944@gmail.com+92-3039007053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026