Sildenafil Citrate and Intrapartum Fetal Distress

NCT ID: NCT04325243

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Fetal Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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study group

50 mg oral sildenafil citrate tablet

Group Type EXPERIMENTAL

Sildenafil 50 mg

Intervention Type DRUG

50 mg oral Sildenafil tablet

placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

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

Interventions

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Sildenafil 50 mg

50 mg oral Sildenafil tablet

Intervention Type DRUG

Placebo oral tablet

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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SC-IPFD

Identifier Type: -

Identifier Source: org_study_id

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