Sildenafil Citrate and Intrapartum Fetal Distress

Assiut University

Status and phase: Completed; Phase 4

Conditions: Fetal Distress

Treatments: Drug: Placebo oral tablet; Drug: Sildenafil 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04325243

SC-IPFD

Details and patient eligibility

About

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

Enrollment: 410 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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410 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

50 mg oral sildenafil citrate tablet

Treatment:

Drug: Sildenafil 50 mg

placebo group

Placebo Comparator group

Description:

placebo tablets of the same shape, color and size of sildenafil citrate tablets

Treatment:

Drug: Placebo oral tablet