Dexamethasone versus betamethasone before delivery: effects on the baby's heart trace
Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography
PHASE4 · Rawalpindi Medical College · NCT07078786
This compares dexamethasone and betamethasone given before delivery to see if one causes fewer changes on fetal heart tracings in people at high risk of preterm birth.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Sex | Female |
| Sponsor | Rawalpindi Medical College (other) |
| Locations | 1 site (Rawalpindi, Punjab Province) |
| Trial ID | NCT07078786 on ClinicalTrials.gov |
What this trial studies
Pregnant people at high risk of preterm birth who are prescribed antenatal steroids will receive either dexamethasone or betamethasone and have fetal heart activity recorded with cardiotocography (CTG) before and after dosing. The trial documents changes in fetal heart rate, accelerations, decelerations, and variability to compare the two steroid effects. People with fetal growth restriction, uteroplacental insufficiency, oligohydramnios, maternal medications that affect fetal heart rate, contraindications to intramuscular injections, or non-reassuring admission CTG are excluded. The goal is to determine whether one steroid produces fewer CTG abnormalities that could lead to unnecessary preterm delivery.
Who should consider this trial
Good fit: Ideal candidates are pregnant people in the third trimester at high risk of preterm birth (for example, with preterm labor, preterm prelabor rupture of membranes, or third-trimester bleeding from placenta previa) who have no exclusions to steroid injections or CTG monitoring.
Not a fit: Patients with fetal growth restriction, uteroplacental insufficiency, oligohydramnios, those on maternal drugs that affect fetal heart rate, those with contraindications to intramuscular injections, or those already admitted with a non-reassuring CTG are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, results could help clinicians choose the steroid that minimizes harmful CTG changes and reduce unnecessary iatrogenic preterm deliveries.
How similar studies have performed: Antenatal steroids are well established to speed fetal lung maturation and prior reports show steroids can transiently alter fetal heart tracings, but direct head-to-head comparisons of dexamethasone versus betamethasone on CTG are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rawalpindi, Punjab Province
- Holy Family Hospital, Rawalpindi Medical University — Rawalpindi, Punjab Province, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Ifra Shafique, MBBS — Rawalpindi Medical Unviersity
- Study coordinator: Ifra Shafique, MBBS
- Email: ifra.shafique1944@gmail.com
- Phone: +92-3039007053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiotocography, Steroids, Antenatal Steroids, Fetal Cardiotocography, Risk of Pre-term birth