NCT05520021

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

September 15, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

August 25, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

NifedipineMagnesium sulfatepregnancypreterm labor threat

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 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

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

Nifedipine treatment

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

Magnesium sulfate treatment

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

RECRUITING

MeSH Terms

Interventions

NifedipineMagnesium Sulfate

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Hasan A Inal

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

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

Locations