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Status unknownNCT05520021MgSO4Updated Sep 15, 2022

The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat

An interventional study of Nifedipine and Magnesium sulfate in Preterm Labor Without Delivery and Pregnancy Preterm, sponsored by Konya Meram State Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by Konya Meram State Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Preterm Labor Without Delivery
  • Pregnancy Preterm

Keywords

  • Nifedipine
  • Magnesium sulfate
  • pregnancy
  • preterm labor threat
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 30 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Konya Meram State Hospital is the lead sponsor of 45 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • pregnancies with preterm labor threat between 28-34 weeks gestational ages

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Magnesium sulfate treatment

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

    Drug: Magnesium sulfate

  • Active comparator
    Nifedipine treatment

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

    Drug: Nifedipine

  • No intervention
    Healthy pregnant women

    A total of 30 pregnancies without preterm labor threat will be included.

Interventions

  • DrugNifedipine

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

  • DrugMagnesium sulfate

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

06

What researchers measure

Primary outcomes

  1. Doppler parameters

    Pulsality index of middle cerebral artery.

    Time frame: Gestational age at delivery (weeks)

Secondary outcomes

  1. Perinatal outcomes

    NICU admission

    Time frame: Gestational age at delivery (weeks)

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05520021
Lead sponsor
Konya Meram State Hospital
Responsible party
Hasan Ali Inal, MD (Clinical Professor, Konya Meram State Hospital) — Principal investigator
First posted
Aug 29, 2022
Start date
Sep 1, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Mar 31, 2023 (estimated)
Last update
Sep 15, 2022

Study contacts

Merve Turk
Contact
drmerveturk@gmail.com
+90 5050 494 20 00
Hasan A Inal
principal investigator · Antalya Training and Research Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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