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Completed

NCT Number: NCT04325243

Sildenafil Citrate and Intrapartum Fetal Distress

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

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Key information

Conditions

Fetal Distress Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy.
  • Pregnant ≥ 37 weeks gestation.
  • Fetus with longitudinal lie and vertex presentation.
  • Healthy fetus with EFW>2500 gm

Exclusion criteria

  • Patients with previous cesarean delivery or uterine surgery.
  • Antepartum hemorrhage.
  • Cephalopelvic disproportion.
  • Category II or III non-stress test.
  • Medical disease as hypertension, cardiac, renal and hepatic disorders
  • Intrauterine fetal death.
  • Fetal growth restriction.
  • Fetuses with major congenital malformations.
  • 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.
  • Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.

Treatment and study plan

Sildenafil 50 mg

Drug

50 mg oral Sildenafil tablet

Placebo oral tablet

Drug

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

Primary outcomes

  1. The rate of cesarean section for intrapartum fetal distress

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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