The Treatment of Magnesium Sulfate and Nifedipine in Pret... | NCT05520021

Studies
The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat

NCT05520021

Sponsor

Konya Meram State Hospital

Status

Unknown status

Last Update Posted

Sep 15, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Preterm Labor Without Delivery
Pregnancy Preterm

Interventions

Nifedipine
Magnesium sulfate

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Mar 31, 2023Estimated

First Submitted Date

Aug 25, 2022

First Submission Date that Met QC Criteria

Aug 26, 2022

First Posted Date

Aug 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2022

Last Update Posted Date

Sep 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hasan Ali Inal, MD, Clinical Professor, Konya Meram State HospitalPrincipal Investigator

Lead Sponsor

Konya Meram State HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium sulfate treatment	Active Comparator	A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.	Drug: Magnesium sulfate
Nifedipine treatment	Active Comparator	A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.	Drug: Nifedipine
Healthy pregnant women	No Intervention	A total of 30 pregnancies without preterm labor threat will be included.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nifedipine	Drug	A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.	Nifedipine treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Merve Turk	Contact	+90 5050 494 20 00		drmerveturk@gmail.com

Overall Officials

Name	Affiliation	Role
Hasan A Inal	Antalya Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hasan Ali Inal	Recruiting	Antalya		07070	Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D009543	Nifedipine
D008278	Magnesium Sulfate

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided