The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat (MgSO4)
Primary Purpose
Preterm Labor Without Delivery, Pregnancy Preterm
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nifedipine
Magnesium sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor Without Delivery focused on measuring Nifedipine, Magnesium sulfate, pregnancy, preterm labor threat
Eligibility Criteria
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
Sites / Locations
- Hasan Ali InalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Magnesium sulfate treatment
Nifedipine treatment
Healthy pregnant women
Arm Description
A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
A total of 30 pregnancies without preterm labor threat will be included.
Outcomes
Primary Outcome Measures
Doppler parameters
Pulsality index of middle cerebral artery.
Secondary Outcome Measures
Perinatal outcomes
NICU admission
Full Information
NCT ID
NCT05520021
First Posted
August 25, 2022
Last Updated
September 14, 2022
Sponsor
Konya Meram State Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05520021
Brief Title
The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat
Acronym
MgSO4
Official Title
Comparison of the Effects of Nifedipine and Magnesium Sulfate on Maternal and Fetal Doppler Blood Flow Patterns in Women With Preterm Labor
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital
4. Oversight
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
5. Study Description
Brief Summary
Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor Without Delivery, Pregnancy Preterm
Keywords
Nifedipine, Magnesium sulfate, pregnancy, preterm labor threat
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium sulfate treatment
Arm Type
Active Comparator
Arm Description
A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
Arm Title
Nifedipine treatment
Arm Type
Active Comparator
Arm Description
A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
Arm Title
Healthy pregnant women
Arm Type
No Intervention
Arm Description
A total of 30 pregnancies without preterm labor threat will be included.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
Primary Outcome Measure Information:
Title
Doppler parameters
Description
Pulsality index of middle cerebral artery.
Time Frame
Gestational age at delivery (weeks)
Secondary Outcome Measure Information:
Title
Perinatal outcomes
Description
NICU admission
Time Frame
Gestational age at delivery (weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Turk
Phone
+90 5050 494 20 00
Email
drmerveturk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan A Inal
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Ali Inal
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hasan A Inal
Phone
4788299
Email
dr.hasanaliinal@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat
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