Management of Acute Preterm Labor: Nifedipen Alone or Combined With Cildenafil Citrate

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study is to assess whether or not the emergency tocolytic effect of combined nifedipine and sildenafil citrate will have a superior effect over nifedipine alone in terms of inhibiting eminent preterm labor and improving perinatal outcomes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Al Hayat National Hospital
• Collaborator: Menoufia University
• Treatments: Citric Acid; Nifedipine; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Pregnant patients presented in outpatient clinic, admitted through emergency room or referred from any other hospitals will be the candidates for the study if they are of any age, any parity, carrying a singleton pregnancy, at a gestational age (GA) between 24 and 34 weeks, and whether or not they had a previous history of PTL.

Exclusion Criteria:

• The presence of major fetal anomaly, intrauterine fetal death, advanced cervical dilatation (>4cm), membranes bulging into the vagina in asymptomatic women, history of ruptured membranes, major antepartum hemorrhage, major chronic medical disorder (such as chronic hypertension, chronic renal disease, and pre-gestational diabetes mellitus as these conditions would increase the risk of PTL and potentially confound the primary study outcome), twins or higher order multiple pregnancy, any other condition in which continuation of the pregnancy can harm the mother or fetus and any contraindication for nifedipin and/or nicorandil therapy.