Preterm Labor With Preterm DeliveryPhase 2NCT04846621
Comparative Study Between Nicorandil and Nifedipine for the Treatment of Preterm Labour
A Phase 2 study testing Potassium Channel Opener and Calcium channel blocker in people with Preterm Labor With Preterm Delivery, run by Ain Shams University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor With Preterm Delivery
- What is being tested?
- Potassium Channel Opener and Calcium channel blocker
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- - 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Manella Fayez Zaki Beshara
Egypt, Alexandria Governorate, 21500
manella beshara, master, 01271750936, michael.leuis89@gmail.com
About this study
Official title: 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
Read the 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
- Conditions
- Preterm Labor With Preterm Delivery
- Being tested
- Potassium Channel Opener, Calcium channel blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Channel OpenerDrug
Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor
Calcium channel blockerDrug
Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor
| Study group | Role | What they receive |
|---|---|---|
| group Nicorandil | Other | women will receive oral Nicorandil 20 mg initially followed by 10 mg at 8 hourly intervals for 48 hours Receives: 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 Receives: Drug: Calcium channel blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours prolongation of pregnancy after starting the studied drug
Secondary outcomes (1)
assess safety of the drug on fetal outcome
By recording the ABGAR score at 1 and 5 minutes after Birth
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Jun 2020
- Primary completionJun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Labor With Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manella fayez, Ain Shams University
- Investigators
- manella beshara, master, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846621
- Sponsor's protocol ID
- preterm labor tocolysis
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35947046
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Nicorandil and Nifedipine for the Treatment of Patients Presenting by Preterm Labor
- ClinicalTrials.gov ID
- NCT04846621
- Acronym / sponsor ID
- preterm labor tocolysis
- Conditions
- Preterm Labor With Preterm Delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group Nicorandil | Other | Drug: Potassium Channel Openerwomen will receive oral Nicorandil 20 mg initially followed by 10 mg at 8 hourly intervals for 48 hours |
| group Nifedipine | Other | Drug: Calcium channel blockerWomen will receive oral Nifedipine loading dose 20 mg orally followed by 10 mg every 8 hours for 48 hours |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- - 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:-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium Channel OpenerRandomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor | Drug | group Nicorandil |
| Calcium channel blockerRandomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor | Drug | group Nifedipine |
Primary outcome
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
1 secondary outcome
assess safety of the drug on fetal outcome
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 35947046Wilson 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
manella beshara, master principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Potassium Channel Opener and Calcium channel blocker in people with Preterm Labor With Preterm Delivery, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact manella beshara, master (01271750936, michael.leuis89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.