Preterm Labor Without DeliveryMgSO4NCT05520021
The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat
A study testing Nifedipine and Magnesium sulfate in people with Preterm Labor Without Delivery and Pregnancy Preterm, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor Without Delivery, Pregnancy Preterm
- What is being tested?
- Nifedipine and Magnesium sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnancies with preterm labor threat between 28-34 weeks gestational ages
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hasan Ali Inal
Antalya, 07070
Hasan A Inal, 4788299, dr.hasanaliinal@gmail.com
About this study
Official title: Comparison of the Effects of Nifedipine and Magnesium Sulfate on Maternal and Fetal Doppler Blood Flow Patterns in Women With Preterm Labor
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.
- Conditions
- Preterm Labor Without Delivery, Pregnancy Preterm
- Being tested
- Nifedipine, Magnesium sulfate
- Keywords
- Nifedipine, Magnesium sulfate, pregnancy, preterm labor threat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineDrug
A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine.
Magnesium sulfateDrug
A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate treatment | Active comparator | A total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate. Receives: Drug: Magnesium sulfate |
| Nifedipine treatment | Active comparator | A total of 30 pregnancies with preterm labor threats will be treated with Nifedipine. Receives: Drug: Nifedipine |
| Healthy pregnant women | No intervention | A total of 30 pregnancies without preterm labor threat will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler parameters
Pulsality index of middle cerebral artery.
Measured: Gestational age at delivery (weeks)
Secondary outcomes (1)
Perinatal outcomes
NICU admission
Measured: Gestational age at delivery (weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Labor Without DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Ali Inal, MD, Konya Meram State Hospital
- Investigators
- Hasan A Inal, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520021
- Sponsor's protocol ID
- 351507
- Acronym
- MgSO4
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Nifedipine and Magnesium Sulfate on Maternal and Fetal Doppler Blood Flow Patterns in Women With Preterm Labor
- ClinicalTrials.gov ID
- NCT05520021
- Acronym / sponsor ID
- MgSO4 / 351507
- Conditions
- Preterm Labor Without Delivery, Pregnancy Preterm
- Keywords
- Nifedipine, Magnesium sulfate, pregnancy, preterm labor threat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate treatment | Active comparator | Drug: Magnesium sulfateA total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate. |
| Nifedipine treatment | Active comparator | Drug: NifedipineA total of 30 pregnancies with preterm labor threats will be treated with Nifedipine. |
| Healthy pregnant women | No intervention | –A total of 30 pregnancies without preterm labor threat will be included. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnancies with preterm labor threat between 28-34 weeks gestational ages
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NifedipineA total of 30 pregnancies with preterm labor threats will be treated with Nifedipine. | Drug | Nifedipine treatment |
| Magnesium sulfateA total of 30 pregnancies with preterm labor threats will be treated with Magnesium sulfate. | Drug | Magnesium sulfate treatment |
Primary outcome
Doppler parameters
Time frame: Gestational age at delivery (weeks)
Pulsality index of middle cerebral artery.
1 secondary outcome
Perinatal outcomes
Time frame: Gestational age at delivery (weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan A Inal principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nifedipine and Magnesium sulfate in people with Preterm Labor Without Delivery and Pregnancy Preterm, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Turk (+90 5050 494 20 00, drmerveturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler parameters (time frame: Gestational age at delivery (weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.