Comparative Study Between Nicorandil and Nifedipine for the Treatment of Preterm Labour

Preterm Labor With Preterm Delivery Clinical Trial

Official title:

Comparative Study Between Nicorandil and Nifedipine for the Treatment of Patients Presenting by Preterm Labor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846621
• Other study ID #: preterm labor tocolysis
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2021
• Source: Ain Shams University
• Contact: manella beshara, master
• Phone: 01271750936
• Email: michael.leuis89[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 compared with Nifedipine as a tocolytic agent in delaying labour for 48 hours following their administration

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 causes of perinatal morbidity and mortality. It is one of the major public health problems, especially with reference to mortality, disability and health care expenses

The diagnosis of preterm labor based upon clinical criteria of regular painful uterine contractions occurs between 20 weeks and before 37 weeks gestation accompanied by cervical change (dilation and/or effacement). Vaginal bleeding and/or ruptured membranes in this setting increase diagnostic certainty , using the following specific criteria:

Uterine contractions (≥4 every 20 minutes or ≥8 in 60 minutes) Plus one of the following:-

• Cervical dilation equal or more than 3 cm

• Cervical length less than 20 mm on transvaginal ultrasound

• Cervical length between 20 to less than 30 mm on transvaginal ultrasound and positive fetal fibronectin test . (This criterion will not be relied upon in this study because it is costly and widely not available in most laboratories)

Since uterine contractions are the most frequently recognized sign of preterm labor, inhibition of uterine contractions with tocolytic agents to prolong pregnancy and reduce neonatal complications has been and continues to be the focus of treatment of preterm labor

• Nifedipine, a calcium channel blocker, could be used as a first line tocolytic agent

Owing to this side effects of Nifedipine, another novel drug (Nicorandil) is studied and according to literature Nicorandil is as effective as Nifedipine for tocolysis in preterm labour

is an anti-angina medication that has the dual properties of a nitrate and ATP-sensitive K+ channel activator. Nicorandil has proved to be safe as anti angina treatement in pergnency

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: July 1, 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• - 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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor With Preterm Delivery

Intervention

Drug:
• Potassium Channel Opener
Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor
• Calcium channel blocker
Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor

Locations

Country	Name	City	State
Egypt	Manella Fayez Zaki Beshara	Egypt	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with successful prolongation of pregnancy for a period of 48 hours following administration of the studied drug.	By follow up of the patients labor progress by the investigator through vaginal examination of the cervical dilatation	48 hours prolongation of pregnancy after starting the studied drug
Secondary	assess safety of the drug on fetal outcome	By recording the ABGAR score at 1 and 5 minutes after Birth	5 minutes