Status:
UNKNOWN
Comparative Study Between Nicorandil and Nifedipine for the Treatment of Preterm Labour
Lead Sponsor:
Ain Shams University
Conditions:
Preterm Labor With Preterm Delivery
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
Nicorandil (potassium channel activator) is claimed to be as effective as Nifedipine (calcium channel blocker) for tocolysis in preterm labour aim of the study: To assess the efficacy of Nicorandil c...
Detailed Description
Preterm labour refers to a delivery that occurs between 20 weeks and before completing 37 weeks of gestation. It may or may not be preceded by preterm labor Preterm labor (PTL) is one of the leading c...
Eligibility Criteria
Inclusion
- BMI between (20 - 30 kg /m²).
- pregnant female with single viable fetus who presented to the outpatient clinic or Emergency room with the criteria of diagnosis of preterm labor between 28 and before completing 34 weeks pregnancy
Exclusion
- \- Any condition in which continuation of pregnancy will jeopardize maternal or fetal welfare.
- Cervix dilatation greater than 4 cm.
- Polyhydramnios \[amniotic fluid index (AFI) greater than 24 cm or deep vertical pocket more than 8 cm.\]
- Oligohydramnios (AFI less than 5 cm).
- Suspected intrauterine infection if Maternal fever is present as a constant feature plus one or more of the following:-
- Maternal leucocytosis (more than 15,000)
- purulent vaginal discharge
- Fetal tachycardia more than 180 bpm.
- Growth restriction.
- Major antepartum hemorrhage
- Major maternal medical disorders such as diabetes, hypertension, systemic lupus,liver and kidney dysfunction .
- Multiple gestation pregnancy.
- Signs of fetal non reassuring CTG
- Signs of fetal abnormal CTG
- Lethal fetal anomaly incompatible with life.
- Premature Rupture of membrane.
- -Contraindication for the use of Nifedipine and/or Nicorandil such as drug allergy, cardiac disease, liver disease and kidney disease
- previous caesarean section
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04846621
Start Date
June 1 2020
End Date
July 1 2021
Last Update
April 15 2021
Active Locations (1)
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1
Manella Fayez Zaki Beshara
Egypt, Alexandria Governorate, Egypt, 21500