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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05520021
Other study ID # 351507
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date March 31, 2023

Study information

Verified date August 2022
Source Konya Meram State Hospital
Contact Merve Turk
Phone +90 5050 494 20 00
Email drmerveturk@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Turkey Hasan Ali Inal Antalya

Sponsors (1)

Lead Sponsor Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Doppler parameters Pulsality index of middle cerebral artery. Gestational age at delivery (weeks)
Secondary Perinatal outcomes NICU admission Gestational age at delivery (weeks)
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