Investigation Into The Efficacy And Safety Of Sildenafil Versus Natural Progesterone For prevention Of Preterm LabourA randomized controlled study

Phase 4

Recruiting

• Conditions: prevention Of Preterm Labour; preterm labour; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Reproductive Health and Childbirth - Antenatal care

• Registration Number: ACTRN12610001017011
• Lead Sponsor: waleed elkhayat

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

pregnant woman 18-24 weeks gestation , the gestational age was estimated by the date of the last menstrual period and confirmed by fetal growth measurement with ultrasound.
-Asymptomatic pregnant woman with a history of at least 1 previous preterm labour( between 20 and 36 weeks plus 6 days gestational age).

Exclusion Criteria

-multiple pregnancy
-premature rupture of membrane
-vaginal bleeding
-diabetes
-history of cardiovascular disease
-herniation of the membrane beyond the external cervical os
-congenital anomalies of the fetus
-any fetal or maternal contraindication to tocolysis(fetal asphyxia, intrauterine growth restriction, pre-ecalmpsia , clinical diagnosis of abruption placentae, placenta previa)
-active liver disease, renal impairment.
- recent stroke or heart attack.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
preterm birth less than 37 weeks gestation ( assessed clinically ).[6 months]

Secondary Outcome Measures

Name	Time	Method
neonatal outcome ( neonatal death , RDS, intraventricular hemorrhage), assessed clinically & by cranial ultrasound.[6 months];drug side effects( headache, flushing, dyspepsia, nasal congestion and impaired vision, including photophobia and blurred vision. hypotension, myocardial infarction (heart attack), ventricular arrhythmias, stroke).<br><br>assessed clinically[6 months]