The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat
MgSO4
Comparison of the Effects of Nifedipine and Magnesium Sulfate on Maternal and Fetal Doppler Blood Flow Patterns in Women With Preterm Labor
1 other identifier
interventional
30
1 country
1
Brief Summary
Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedSeptember 15, 2022
August 1, 2022
4 months
August 25, 2022
September 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Doppler parameters
Pulsality index of middle cerebral artery.
Gestational age at delivery (weeks)
Secondary Outcomes (1)
Perinatal outcomes
Gestational age at delivery (weeks)
Study Arms (3)
Magnesium sulfate treatment
ACTIVE COMPARATORA total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
Nifedipine treatment
ACTIVE COMPARATORA total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
Healthy pregnant women
NO INTERVENTIONA total of 30 pregnancies without preterm labor threat will be included.
Interventions
A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
Eligibility Criteria
You may qualify if:
- pregnancies with preterm labor threat between 28-34 weeks gestational ages
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hasan Ali Inal
Antalya, 07070, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hasan A Inal
Antalya Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 25, 2022
First Posted
August 29, 2022
Study Start
September 1, 2022
Primary Completion
December 31, 2022
Study Completion
March 31, 2023
Last Updated
September 15, 2022
Record last verified: 2022-08