NCT02372487

Brief Summary

The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will remain Sildenafil-naïve.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

February 10, 2015

Last Update Submit

February 2, 2016

Conditions

Pregnancy Complication

Outcome Measures

Primary Outcomes (1)

  • the values of amniotic fluid index before and after therapy in each group and between both groups

    9 months

Secondary Outcomes (5)

  • mode of delivery

    9 months

  • gestational age at birth

    9 months

  • fetal birth weight

    9 months

  • Apgar scores

    9 months

  • the need for transfer to the neonatal intensive care unit

    9 months

Study Arms (2)

fluid therapy and sildenafil citrate

ACTIVE COMPARATOR

Patients in first group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour in addition to sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily during hospitalization. After discharge patients in first group will be asked to continue sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily plus a daily oral fluid intake of 2 liters

Drug: sildenafil citrateDietary Supplement: fluid therapy

fluid therapy

ACTIVE COMPARATOR

Patients in second group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour. After discharge patients wil be asked to have 2 liters daily oral fluid

Dietary Supplement: fluid therapy

Interventions

sildenafil citrateDRUG

sildenafil citrate 25 mg every 8 hours

fluid therapy and sildenafil citrate
fluid therapyDIETARY_SUPPLEMENT

2 liters of fluid per day

fluid therapyfluid therapy and sildenafil citrate

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women will be included if they are of:
  • any age, any parity
  • carrying a singleton pregnancy
  • gestational age (GA) 30 weeks or more (based on the last menstrual period and confirmed by the results of ultrasound or determined through early pregnancy sonography)
  • Amniotic fluid index ≤ 5
  • no pregnancy complications such as preeclampsia, gestational hypertension, or diabetes
  • no prior history of kidney, lung, and heart disease (the use of bolus-fluid therapy is contraindicated in these patients)
  • intact fetal membranes.

You may not qualify if:

  • Mothers treated with prostaglandin synthetase inhibitors
  • well established labor
  • evidence of fetal distress (non-reactive non stress test)
  • fetal complications (intrauterine growth retardation or obvious fetal anomalies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Menoufia University

Shebin Elkom, Egypt

RECRUITING

Alhayah national hospital

Abhā, Saudi Arabia

RECRUITING

Alhayah national hospital

Abhā, Saudi Arabia

RECRUITING

Related Publications (1)

  • Maher MA, Sayyed TM, Elkhouly N. Sildenafil Citrate Therapy for Oligohydramnios: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):615-620. doi: 10.1097/AOG.0000000000001928.

    PMID: 28277352DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Sildenafil CitrateFluid Therapy

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 26, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

SA(2)EG(1)