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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ain Shams University
• Treatments: Calcium; Calcium Channel Blockers

Criteria

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