The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat (MgSO4)

September 14, 2022 updated by: Hasan Ali Inal, MD, Konya Meram State Hospital

Comparison of the Effects of Nifedipine and Magnesium Sulfate on Maternal and Fetal Doppler Blood Flow Patterns in Women With Preterm Labor

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Magnesium sulfate treatment
A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
Drug: Magnesium sulfate
A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
ACTIVE_COMPARATOR: Nifedipine treatment
A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
Drug: Nifedipine
A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
NO_INTERVENTION: Healthy pregnant women
A total of 30 pregnancies without preterm labor threat will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doppler parameters
Time Frame: Gestational age at delivery (weeks)
Pulsality index of middle cerebral artery.
Gestational age at delivery (weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal outcomes
Time Frame: Gestational age at delivery (weeks)
NICU admission
Gestational age at delivery (weeks)

Collaborators and Investigators

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

Sponsor

Konya Meram State Hospital

Investigators

  • Principal Investigator: Hasan A Inal, Antalya Training 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)

September 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

March 31, 2023

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (ACTUAL)

August 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 351507

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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