Overview

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.