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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pregnancies using nifedipine and MgSO4 for tocolytic purposes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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