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

April 13, 2021 updated by: Manella fayez, Ain Shams University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Alexandria
      • Egypt, Alexandria, Egypt, 21500
        • Recruiting
        • Manella Fayez Zaki Beshara
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: group Nicorandil
women will receive oral Nicorandil 20 mg initially followed by 10 mg at 8 hourly intervals for 48 hours
Drug: Potassium Channel Opener
Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor
Other: group Nifedipine
Women will receive oral Nifedipine loading dose 20 mg orally followed by 10 mg every 8 hours for 48 hours
Drug: Calcium channel blocker
Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with successful prolongation of pregnancy for a period of 48 hours following administration of the studied drug.
Time Frame: 48 hours prolongation of pregnancy after starting 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess safety of the drug on fetal outcome
Time Frame: 5 minutes
By recording the ABGAR score at 1 and 5 minutes after Birth
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: manella beshara, master, ain shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • preterm labor tocolysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

in about 3 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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