NCT07078786

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

July 12, 2025

Last Update Submit

August 7, 2025

Conditions

CardiotocographySteroids

Keywords

Antenatal SteroidsFetal CardiotocographyRisk of Pre-term birth

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group Betamethasone

EXPERIMENTAL

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

Drug: Betamethason Sodium Phosphate

Group Dexmaethasone

ACTIVE COMPARATOR

24mg of Dexamethasone in two divided doses will be given Intramuscularly over 24 hours apart

Drug: Dexamethasone

Interventions

Betamethason Sodium PhosphateDRUG

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

Group Betamethasone
DexamethasoneDRUG

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

Group Dexmaethasone

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Females with Gestational age 30-37 weeks are included in the study
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of pre term labor
  • Preterm pre labor rupture of membranes
  • Third trimester bleeding due to placenta previa

You may not qualify if:

  • IUGR
  • Uteroplacental insufficiency
  • Oligohydroamnios
  • Maternal drug therapy that can effect fetal heart rate
  • Contraindications to Intramuscular injections
  • Patients admitted with non reassuring CTG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holy Family Hospital, Rawalpindi Medical University

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (1)

  • 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: 10376858BACKGROUND

Related Links

MeSH Terms

Interventions

betamethasone sodium phosphateDexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ifra Shafique, MBBS

    Rawalpindi Medical Unviersity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ifra Shafique, MBBS

CONTACT

+92-3039007053ifra.shafique1944@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be randomly divided into two groups using computer generated numbers and will be masked to the treatment they receive. The person assessing outcome i.e. fetal cardiotography activity will be masked to the treatment participant received.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

July 13, 2025

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)