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Sildenafil Citrate and Intrapartum Fetal Distress

Primary Purpose

Fetal Distress

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil 50 mg
Placebo oral tablet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fetal Distress

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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
  5. Intact membranes.

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.

Sites / Locations

  • Ahmed Abbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

placebo group

Arm Description

50 mg oral sildenafil citrate tablet

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2020
Last Updated
January 30, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04325243
Brief Title
Sildenafil Citrate and Intrapartum Fetal Distress
Official Title
Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Distress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
50 mg oral sildenafil citrate tablet
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo tablets of the same shape, color and size of sildenafil citrate tablets
Intervention Type
Drug
Intervention Name(s)
Sildenafil 50 mg
Intervention Description
50 mg oral Sildenafil tablet
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy
Primary Outcome Measure Information:
Title
The rate of cesarean section for intrapartum fetal distress
Description
Fetus will be considered to be distressed if Ominous fetal heart rate changes led to cesarean section was present
Time Frame
24 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

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Sildenafil Citrate and Intrapartum Fetal Distress

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