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NCT Number: NCT07078786

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

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.

Recruiting

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Key information

Conditions

Cardiotocography Steroids

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Holy Family Hospital, Rawalpindi Medical University

Rawalpindi, Punjab Province, 46000, Pakistan

Location status: Recruiting

Location contact

Tallat Farkhanda, MBBS,FCPS

CONTACT

+92-323-5112728

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ifra Shafique, MBBS

CONTACT

[email protected]

+92-3039007053

Sponsors and collaborators

Lead sponsor

Rawalpindi Medical College

Other

Collaborators

  • Rawalpindi Medical College, Pakistan

Registry information

Official study title

Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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