Sildenafil Citrate and Intrapartum Fetal Distress

Assiut University410 enrolled

Overview

Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. In spite of significant advances in methods of IOL and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

410

Conditions

Fetal Distress

Interventions

Sildenafil 50 mgDRUG

50 mg oral Sildenafil tablet

Placebo oral tabletDRUG

placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: 1. Singleton pregnancy. 2. Pregnant ≥ 37 weeks gestation. 3. Fetus with longitudinal lie and vertex presentation. 4. Healthy fetus with EFW\>2500 gm Exclusion Criteria: 1. Patients with previous cesarean delivery or uterine surgery. 2. Antepartum hemorrhage. 3. Cephalopelvic disproportion. 4. Category II or III non-stress test. 5. Medical disease as hypertension, cardiac, renal and hepatic disorders 6. Intrauterine fetal death. 7. Fetal growth restriction. 8. Fetuses with major congenital malformations. 9. Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors. 10. Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.

Locations (1)

Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

The rate of cesarean section for intrapartum fetal distress

Fetus will be considered to be distressed if Ominous fetal heart rate changes led to cesarean section was present

Time frame: 24 hours

Data from ClinicalTrials.gov

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