The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat

NCT ID: NCT05520021

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the investigators aim to compare the effect of Nifedipine and MgSO4 therapies on Doppler parameters of the uterine, umbilical, middle cerebral arteries, and ductus venous in the first 48 hours of therapy in pregnancies with preterm labor threat and also compare perinatal outcomes after delivery between the groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Labor Without Delivery Pregnancy Preterm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magnesium sulfate treatment

A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.

Group Type ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type DRUG

A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.

Nifedipine treatment

A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.

Healthy pregnant women

A total of 30 pregnancies without preterm labor threat will be included.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nifedipine

A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.

Intervention Type DRUG

Magnesium sulfate

A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* pregnancies with preterm labor threat between 28-34 weeks gestational ages

Exclusion Criteria

* Cervical dilatation at \> 4 cm and/or cervical effacement \>80%,
* Multiple pregnancies,
* Pregnancy complications including preeclampsia, ablatio placenta, intrauterine growth restriction, placenta previa, gestational diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hasan Ali Inal, MD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hasan A Inal

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hasan Ali Inal

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Merve Turk

Role: CONTACT

+90 5050 494 20 00

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hasan A Inal

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

351507

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Magnesium Sulfate in Pregnancy and Postpartum
NCT02317146 COMPLETED PHASE2/PHASE3
Magnesium Sulphate in Perinatal Asphyxia
NCT00553072 COMPLETED PHASE3