CardiotocographyPhase 4NCT07078786
Effect of Pre-delivery Dexamethasone in Comparison With Betamethasone on Fetal Heart Trace
A Phase 4 study testing Betamethason Sodium Phosphate and Dexamethasone in people with Cardiotocography and Steroids, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiotocography, Steroids
- What is being tested?
- Betamethason Sodium Phosphate and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jul 2025to 15 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- History of pre term labor
- Preterm pre labor rupture of membranes
- Third trimester bleeding due to placenta previa
Who cannot join
- IUGR
- Uteroplacental insufficiency
- Oligohydroamnios
- Maternal drug therapy that can effect fetal heart rate
- Contraindications to Intramuscular injections
- Patients admitted with non reassuring CTG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Holy Family Hospital, Rawalpindi Medical University
Rawalpindi, Punjab Province, 46000
Tallat Farkhanda, MBBS,FCPS, +92-323-5112728
About this study
Official title: Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography
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.
Read the 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.
- Conditions
- Cardiotocography, Steroids
- Being tested
- Betamethason Sodium Phosphate, Dexamethasone
- Keywords
- Antenatal Steroids, Fetal Cardiotocography, Risk of Pre-term birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethason Sodium PhosphateDrug
Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days
DexamethasoneDrug
two doses of 12mg of IM Dexamethasone given 24 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Group Betamethasone | Experimental | Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days Receives: Drug: Betamethason Sodium Phosphate |
| Group Dexmaethasone | Active comparator | 24mg of Dexamethasone in two divided doses will be given Intramuscularly over 24 hours apart Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of accelerations on fetal cardiotocography
Measured: Before intervention, 2 and 4 days after intervention
Long term heart rate variability on fetal cardiotocography
Measured: Before intervention, 2 and 4 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start13 Jul 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiotocographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Rawalpindi Medical College, Pakistan
- Responsible party
- Principal investigator, Ifra Shafique, Rawalpindi Medical College
- Investigators
- Ifra Shafique, MBBS, Principal investigator, Rawalpindi Medical Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078786
- Sponsor's protocol ID
- 1080/IREF/RMU/2024
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 10376858
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography
- ClinicalTrials.gov ID
- NCT07078786
- Acronym / sponsor ID
- 1080/IREF/RMU/2024
- Conditions
- Cardiotocography, Steroids
- Keywords
- Antenatal Steroids, Fetal Cardiotocography, Risk of Pre-term birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Collaborators
- Rawalpindi Medical College, Pakistan
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Betamethasone | Experimental | Drug: Betamethason Sodium PhosphateIntramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days |
| Group Dexmaethasone | Active comparator | Drug: Dexamethasone24mg of Dexamethasone in two divided doses will be given Intramuscularly over 24 hours apart |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- History of pre term labor
- Preterm pre labor rupture of membranes
- Third trimester bleeding due to placenta previa
Key exclusion criteria (6 listed)
- IUGR
- Uteroplacental insufficiency
- Oligohydroamnios
- Maternal drug therapy that can effect fetal heart rate
- Contraindications to Intramuscular injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethason Sodium PhosphateIntramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days | Drug | Group Betamethasone |
| Dexamethasonetwo doses of 12mg of IM Dexamethasone given 24 hours apart | Drug | Group Dexmaethasone |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 10376858Rotmensch 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ifra Shafique, MBBS principal investigator
Rawalpindi Medical Unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betamethason Sodium Phosphate and Dexamethasone in people with Cardiotocography and Steroids, run by Rawalpindi Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ifra Shafique, MBBS (+92-3039007053, ifra.shafique1944@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of accelerations on fetal cardiotocography (time frame: Before intervention, 2 and 4 days after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07078786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.