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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorRawalpindi Medical College

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

History of pre term labor

Preterm pre labor rupture of membranes

Third trimester bleeding due to placenta previa

Disqualifiers

IUGR

Uteroplacental insufficiency

Oligohydroamnios

Maternal drug therapy that can effect fetal heart rate

Trial design

Design model

Parallel

Treatments tested in this trial

  • Betamethason Sodium Phosphate

    Drug

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

  • Dexamethasone

    Drug

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Group BetamethasoneExperimental treatment 1 intervention
Group B: Group DexmaethasoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean number of accelerations on fetal cardiotocography

Time frame
Before intervention, 2 and 4 days after intervention
2

Long term heart rate variability on fetal cardiotocography

Time frame
Before intervention, 2 and 4 days after intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rawalpindi Medical College

Lead sponsor

Rawalpindi Medical College, Pakistan

Collaborator