The effect of betamethasone and dexamethasone on fetal heart rate patterns and biophysical activities. A prospective randomized trial.
S Rotmensch, M Liberati, T H Vishne...
https://pubmed.ncbi.nlm.nih.gov/10376858Actively Recruiting
Phase 4
FEMALE
Healthy Volunteers
ID07078786
Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiotocography
Led by Rawalpindi Medical College · Updated on 2025-08-12
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rawalpindi Medical College
Lead Sponsor
R
Rawalpindi Medical College, Pakistan
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates the effects of two steroids, Dexamethasone and Betamethasone, on fetal heart activity in mothers at high risk of preterm birth. These steroids are given to speed up lung development in the baby before delivery, but they may affect the baby's heart rate differently as seen on fetal heart monitoring called cardiotocography (CTG). Participants will receive either Betamethasone or Dexamethasone through intramuscular injections. Betamethasone is given as 12 mg injections on two consecutive days, while Dexamethasone is given as two 12 mg doses spaced 24 hours apart. The study follows a randomized, double-blind design to compare these two treatment groups. During the study, fetal heart rate and its variations will be monitored before treatment and again at two and four days after treatment using CTG. Researchers will measure the number of heart rate accelerations and long-term heart rate variability to assess fetal well-being. The study will also monitor participants for any safety concerns related to the treatments.
CONDITIONS
Brief Title
Effect of Pre-delivery Dexamethasone in Comparison With Betamethasone on Fetal Heart Trace
Who Can Participate
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- History of pre term labor
- Preterm pre labor rupture of membranes
- Third trimester bleeding due to placenta previa
You will not qualify if you...
- Intrauterine growth restriction (IUGR)
- Uteroplacental insufficiency
- Oligohydroamnios
- Maternal drug therapy that can affect fetal heart rate
- Contraindications to intramuscular injections
- Patients admitted with non reassuring cardiotocography (CTG)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 days
Participants receive intramuscular injections of either Betamethasone or Dexamethasone to support fetal lung development and observe effects on fetal heart activity.
2 visits (in-person) on consecutive days
Follow-up
Duration - 4 days
Participants undergo monitoring of fetal heart activity using cardiotocography before and after treatment to assess effects over time.
3 visits (in-person) before treatment, 2 days after, and 4 days after treatment
Trial Site Locations
Total: 1 location
1
Holy Family Hospital, Rawalpindi Medical University
Rawalpindi, Punjab Province, Pakistan, 46000
Actively Recruiting
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Research Team
I
Ifra Shafique, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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