NCT03475160

Brief Summary

Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation. The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

December 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 9, 2018

Last Update Submit

March 16, 2018

Conditions

Recurrent Abortion

Outcome Measures

Primary Outcomes (1)

  • The difference between both groups in live birth

    Live birth is defined as an ongoing pregnancy past to the 20th week of gestation

    Through study completion, an average of 9 months.

Secondary Outcomes (4)

  • Uterine artery PI at cycle day 21-23 preceding pregnancy

    At cycle day 21-23 preceding pregnancy

  • Uterine artery RI at cycle day 21-23 preceding pregnancy

    At cycle day 21-23 preceding pregnancy

  • Uterine artery PI at the twelfth week of gestation

    At the twelfth week of gestation.

  • Uterine artery RI at the twelfth week of gestation

    At the twelfth week of gestation.

Study Arms (2)

Sildenafil Citrate

ACTIVE COMPARATOR

Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Drug: Sildenafil Citrate vaginal suppositoriesProcedure: Uterine artery Doppler before treatmentProcedure: Uterine artery Doppler after treatment

Placebo

PLACEBO COMPARATOR

Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Drug: Placebo vaginal suppositoriesProcedure: Uterine artery Doppler before treatmentProcedure: Uterine artery Doppler after treatment

Interventions

Sildenafil Citrate vaginal suppositoriesDRUG

Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Also known as: Sildenafil Citrate
Sildenafil Citrate
Placebo vaginal suppositoriesDRUG

Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.

Also known as: Placebo
Placebo
Uterine artery Doppler before treatmentPROCEDURE

Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy

PlaceboSildenafil Citrate
Uterine artery Doppler after treatmentPROCEDURE

Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation

PlaceboSildenafil Citrate

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unexplained recurrent spontaneous abortion.

You may not qualify if:

  • Abnormal uterine cavity.
  • Luteal phase insufficiency.
  • Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.
  • Antiphospholipid syndrome.
  • Inherited or acquired thrombophilia.
  • Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 23, 2018

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03