Effect of Pre-delivery Dexamethasone in Comparison With Betamethasone on Fetal Heart Trace
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Betamethason Sodium Phosphate, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Cardiotocography, Steroids. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography
Overview
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
- Drug Betamethason Sodium Phosphate
Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days - Drug Dexamethasone
two doses of 12mg of IM Dexamethasone given 24 hours apart
Primary outcome measures
- Mean number of accelerations on fetal cardiotocography [Time frame: Before intervention, 2 and 4 days after intervention]
- Long term heart rate variability on fetal cardiotocography [Time frame: Before intervention, 2 and 4 days after intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Pakistan · 1 center
- Holy Family Hospital, Rawalpindi Medical University — Rawalpindi
Publications
- Rotmensch S, Liberati M, Vishne TH, Celentano C, Ben-Rafael Z, Bellati U. The effect of betamethasone and dexamethasone on fetal heart rate patterns and biophysical activities. A prospective randomized trial. Acta Obstet Gynecol Scand. 1999 Jul;78(6):493-500. PMID 10376858
Identifiers
NCT: NCT07078786 · 1080/IREF/RMU/2024