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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
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:-
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group Nicorandil | Other | women will receive oral Nicorandil 20 mg initially followed by 10 mg at 8 hourly intervals for 48 hours |
|
| group Nifedipine | Other | Women will receive oral Nifedipine loading dose 20 mg orally followed by 10 mg every 8 hours for 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Channel Opener | Drug | Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| assess safety of the drug on fetal outcome | By recording the ABGAR score at 1 and 5 minutes after Birth | 5 minutes |
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Inclusion Criteria:
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:-
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| manella beshara, master | Contact | 01271750936 | michael.leuis89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| manella beshara, master | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manella Fayez Zaki Beshara | Recruiting | Egypt | Alexandria Governorate | 21500 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35947046 | Derived | 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. |
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in about 3 months
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| ID | Term |
|---|---|
| D002121 | Calcium Channel Blockers |
| ID | Term |
|---|---|
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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all cases in both groups will not know which drug they receive
| Calcium channel blocker | Drug | Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor |
|
| D000077264 | Calcium-Regulating Hormones and Agents |
| D045505 | Physiological Effects of Drugs |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |