Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate

November 16, 2025 updated by: Sanliurfa Education and Research Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Sanliurfa, Turkey (Türkiye), 63100
        • Sanlıurfa Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pregnancies using nifedipine and MgSO4 for tocolytic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of nifedipine or MgSO4 as tocolytic agents
Time Frame: 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.
Fetal echocardiographic findings after 48 hours the use of nifedipine or MgSO4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

June 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEAH-CARD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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