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

Not Applicable

Recruiting

• Conditions: Cardiotocography; Steroids
• Interventions: Drug: Betamethason Sodium Phosphate; Drug: Dexamethasone

• Registration Number: NCT07078786
• Lead Sponsor: Rawalpindi Medical College

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.

Study Timeline

• Study First Submitted: 2025-07-12
• Study First Submitted QC: 2025-07-12
• Study Start: 2025-07-13
• Study First Posted: 2025-07-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-12
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Betamethasone	Betamethason Sodium Phosphate	Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days
Group Dexmaethasone	Dexamethasone	24mg of Dexamethasone in two divided doses will be given Intramuscularly over 24 hours apart

Primary Outcome Measures

Name	Time	Method
Mean number of accelerations on fetal cardiotocography	Before intervention, 2 and 4 days after intervention
Long term heart rate variability on fetal cardiotocography	Before intervention, 2 and 4 days after intervention

Trial Locations

Locations (1)

Holy Family Hospital, Rawalpindi Medical University; 🇵🇰 Rawalpindi, Punjab, Pakistan