Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate

NCT06904534 — Active not recruiting, 100 participants, Sanliurfa Education and Research Hospital

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Comparison of Fetal Cardiac Functions in Pregnant Women Using Nifedipine and Magnesium Sulfate for Tocolysis

RegistryNCT06904534
StatusActive not recruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorSanliurfa Education and Research Hospital (Other gov)
ConditionsUnexpected Fetal Cardiac Effects of Nifedipine and MgSO4
Datesstart 2025-01-01, primary completion 2025-06-30, completion 2025-11-30 (estimated), first posted 2025-04-01, last updated 2025-11-18
Locations1 site in Turkey (Türkiye)

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All trials for Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4

-Summary

The potential unexpected effects of nifedipine and MgSO4, the tocolytic agents used for the indication of preterm labor, on fetal heart will be determined. In this study, the fetal echocardiographic findings of nifedipine and MgSO4 will be compared.

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+Detailed description

This study will include pregnancies at 24-34 weeks of gestation that are using nifedipine and MgSO4 for tocolysis. Fetal echocardiographic findings of these pregnancies will be recorded

+Arms and interventions

ArmTypeInterventionsDescription
Pregnancies using nifedipine and MgSO4 for tocolytic purposes

+Outcome measures

Primary outcomes

  • Use of nifedipine or MgSO4 as tocolytic agents [Fetal echocardiographic findings after 48 hours the use of nifedipine or MgSO4]: Pregnancies between 24-34 weeks of gestation using nifedipine and MgSO4 for tocolysis will be evaluated. Preterm labor is defined as persistent uterine contractions (at least two contractions every 10 minutes or four contractions in 1 hour) resulting in cervical changes (at least 80% effacement and 2 cm cervical dilation). Nifedipine will be administered as an initial 10 mg oral loading dose every 20 minutes for one hour, followed by 10 mg oral maintenance doses every 6 hours for 48 hours. The MgSO4 treatment protocol involves a 100 mL infusion of 5% dextrose containing 4-6 grams of MgSO4 (MgSO4 15% amp.) as an intravenous (IV) loading dose over 20 minutes, followed by a maintenance dose of 2 grams per hour IV. During treatment, patients will be monitored hourly for urination patterns, deep tendon reflexes, and respiratory rate. Treatment will be stopped 6 hours after the cessation of contractions. Doppler measurements will be taken before the first treatment dose and 48 hours after.

+Eligibility

Sex: Female, ages: 18 Years to 50 Years

Inclusion Criteria:-Patients with preterm labor indication at 24-34 weeks of gestation

-Treated with nifedipine or MgSO4 for tocolysis

Exclusion Criteria:

* Multiple pregnancy
* premature rupture of membranes
* Chorioamnionitis
* Placental abruption
* Severe fetal growth restriction
* Congenital anomalies of the fetus
* Preeclampsia
* Oligohydramnios
* Maternal diabetes
* Contraindications for the use of nifedipine and/or MgSO4 in the mother

+Locations (1)

FacilityCityCountryStatus
Şanlıurfa Training and Research HospitalSanliurfaTurkey (Türkiye)