Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate

NCT06904534 | Active Not Recruiting

• 1 other identifier: SEAH-CARD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4

Keywords

Nifedipine; MgSO4; Fetal echocardiography.

Outcome Measures

Primary Outcomes (1)

• Use of nifedipine or MgSO4 as tocolytic agents

  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.

  Fetal echocardiographic findings after 48 hours the use of nifedipine or MgSO4

Study Arms (1)

Pregnancies using nifedipine and MgSO4 for tocolytic purposes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with preterm labor indication at 24-34 weeks of gestation who are treated with nifedipine or MgSO4 for tocolysis

You may qualify if:

• Treated with nifedipine or MgSO4 for tocolysis

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

Study Sites (1)

Şanlıurfa Training and Research Hospital

Sanliurfa, 63100, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 1, 2025
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)