NCT04846621

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 7, 2021

Last Update Submit

April 13, 2021

Conditions

Preterm Labor With Preterm Delivery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • assess safety of the drug on fetal outcome

    5 minutes

Study Arms (2)

group Nicorandil

OTHER

women will receive oral Nicorandil 20 mg initially followed by 10 mg at 8 hourly intervals for 48 hours

Drug: Potassium Channel Opener

group Nifedipine

OTHER

Women will receive oral Nifedipine loading dose 20 mg orally followed by 10 mg every 8 hours for 48 hours

Drug: Calcium channel blocker

Interventions

Potassium Channel OpenerDRUG

Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor

group Nicorandil
Calcium channel blockerDRUG

Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor

group Nifedipine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manella Fayez Zaki Beshara

Egypt, Alexandria Governorate, 21500, Egypt

RECRUITING

Related Publications (1)

  • Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

    PMID: 35947046DERIVED

MeSH Terms

Interventions

Calcium Channel Blockers

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic Uses

Study Officials

  • manella beshara, master

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

manella beshara, master

CONTACT

01271750936michael.leuis89@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
all cases in both groups will not know which drug they receive
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miami, Alexandria Egypt

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 15, 2021

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
in about 3 months

Locations

EG(1)