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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001017011

Enrollment

Registered

2010-11-22

Start date

2010-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

to use sildenafil to prevent preterm labour with high effeicacy & most safe , as it is an excellent muscle relaxant.

Interventions

sildenafil 100 mg vaginally every 12 hours , for 10 weeks prior to scheduled labour

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Outcome results