Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4NCT06904534
Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate
An observational study of Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with preterm labor indication at 24-34 weeks of gestation who are treated with nifedipine or MgSO4 for tocolysis
Who may be able to join
None listed.
Who cannot join
- Multiple pregnancy
- premature rupture of membranes
- Chorioamnionitis
- Placental abruption
- Severe fetal growth restriction
- Congenital anomalies of the fetus
Show all 10Show fewer
- Preeclampsia
- Oligohydramnios
- Maternal diabetes
- Contraindications for the use of nifedipine and/or MgSO4 in the mother
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şanlıurfa Training and Research Hospital
Sanliurfa, 63100
About this study
Official title: 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.
Read the 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
- Keywords
- Nifedipine, MgSO4, Fetal echocardiography.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancies using nifedipine and MgSO4 for tocolytic purposes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Fetal echocardiographic findings after 48 hours the use of nifedipine or MgSO4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904534
- Sponsor's protocol ID
- SEAH-CARD
- Status last verified
- Nov 2025
- First submitted
- 23 Mar 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fetal Cardiac Functions in Pregnant Women Using Nifedipine and Magnesium Sulfate for Tocolysis
- ClinicalTrials.gov ID
- NCT06904534
- Acronym / sponsor ID
- SEAH-CARD
- Keywords
- Nifedipine, MgSO4, Fetal echocardiography.
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancies using nifedipine and MgSO4 for tocolytic purposes | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with preterm labor indication at 24-34 weeks of gestation who are treated with nifedipine or MgSO4 for tocolysis
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Multiple pregnancy
- premature rupture of membranes
- Chorioamnionitis
- Placental abruption
- Severe fetal growth restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of nifedipine or MgSO4 as tocolytic agents (time frame: Fetal echocardiographic findings after 48 hours the use of nifedipine or MgSO4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.