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Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss

Primary Purpose

Recurrent Pregnancy Loss

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil 25Mg Tablet
Placebo Oral Tablet
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pregnancy Loss

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. History of 2 or more unexplained recurrent miscarriage.
  2. Child bearing period (18-35 years old).
  3. Non pregnant state.
  4. Regular menstrual cycles for the previous three months before the study.
  5. No hormonal contraception or intrauterine device.
  6. impaired uterine artery blood flow (PI >2.02) (Mansour et al., 2018).

Exclusion Criteria:

  • 1-Having any possible causes of abortion: anatomical, genetic, endocrinological, infectious, or immunological.

    2- Autoimmune disorders which may affect blood vessels and their blood flow (systemic lupus).

    3- Systemic disease that might affect the hemodynamic indices (e.g. thrombocytopenia, thyrotoxicosis … etc.).

    4- Diagnosed or treated thrombophilia. 5- Any vascular disease (e.g. coronary artery disease). 6- History of oophorectomy. 7- History of consanguinity. 8- Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13… etc.).

Sites / Locations

  • Ain shams university maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sildenafil citrate

placebo

Arm Description

Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours.

placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours.

Outcomes

Primary Outcome Measures

uterine artery blood flow indices
uterine artery PI, RI

Secondary Outcome Measures

Full Information

First Posted
January 16, 2021
Last Updated
January 20, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04718233
Brief Title
Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss
Official Title
Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss Due to Impaired Uterine Artery Blood Flow
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with recurrent pregnancy loss are known to have decreased uterine artery blood flow. Nitric oxide plays a major role in increasing uterine blood flow during the luteal phase. This study is done to evaluate the effects of sildenafil on blood flow indices in the patients with recurrent pregnancy loss due to impaired uterine artery blood flow.
Detailed Description
Study Setting: The study will be conducted in recurrent pregnancy loss outpatient clinic at Ain shams university maternity hospital. Study Population: Patients with unexplained recurrent miscarriage attending Ain shams university maternity hospital's outpatient clinic. This study will be conducted on 80 women distributed into 2 groups each is 40 women in fertile age with history of two or more recurrent spontaneous abortions and decreased uterine artery blood flow(PI>2.02(Mansour et al., 2018). First group will be placebo controlled and the second group will be given sildenafil citrate. Women will be asked to attend during the 21-23 day of the cycle and will be subjected to: History taking and Full clinical examination. Clinical examination will be done including general, abdominal and pelvic examination. General examination: including general appearance, weight, height and vital signs Abdominal examination: to assure freedom of any organic clinically detectable pathologic lesions. Pelvic examination: included inspection of the external genitalia, speculum examination of the vagina to rule out infection, and bimanual assessment of uterine size and position as well as exclusion of adnexal masses. Laboratory investigations: Routine investigations including: CBC, fasting and postprandial blood sugar, urine analysis, kidney function and liver function will be done. The endocrine evaluation consisted in measuring thyroid-stimulating hormone, free thyroxin, and progesterone levels on day 21 of the menstrual cycle. Sonography: Sonography will be performed using Samsung H60 with convex probe (multi-frequency AD 2~ 8 MHz) to perform trans-vaginal examination. Examination will be performed in the second phase of the menstrual cycle, at mid-luteal day. Pulsed wave Doppler will be used to obtain clear, consistent, flow velocity wave forms of both uterine arteries. Pulsatility index (PI) will be measured bilaterally. The PI reported will be the arithmetic mean for the last three cardiac cycles. (Goswamy and Steptoe, 1988) classification will be used to determine the wave types. According to this classification, the FVW of the circumflex artery can be of 3 types : Type A when the diastolic component is present but not continuous with the systole, and ends before the next cardiac cycle. Type B when a diastole is present and continues with the systole, but ends before the next cardiac cycle. Type C when a diastole is present and continues with the systole and into the next cardiac cycle. The majority of research has centered on an elevation in the RI or PI to detect the presence of increased uterine artery blood flow resistance in non- pregnant states. Criteria for an abnormal uterine artery Pulsatility index (PI) cutoff (PI> 2.02) and abnormal sub-endometrial blood flow Resistant Index (RI) (RI>0.6) (Mansour et al., 2018). Steps and methods: The participants will be two groups of 80 patients with history of recurrent pregnancy loss, each is 40. All patients will be scanned transvaginally with transvaginal Doppler sonography 6 to 8 days after ovulation to measure the pulsatility index (PI), resistance index (RI) and systolic to diastolic ratio (S/D) of the right and left main uterine arteries and sub-endometrial blood flow resistance index (RI). Sildenafil citrate at a dose of 25mg or placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured after 3 hours. The student test will be used for analysis of the results, P< 0.05 will be considered significant. With 95% confidence interval. P values ≥5% considered to be significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sildenafil citrate
Arm Type
Experimental
Arm Description
Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo will be administered orally in patients with recurrent pregnancy loss and the blood flow indices will be measured initially and after 3 hours.
Intervention Type
Drug
Intervention Name(s)
Sildenafil 25Mg Tablet
Intervention Description
Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
placebo will be administered orally in patients with recurrent pregnancy loss
Primary Outcome Measure Information:
Title
uterine artery blood flow indices
Description
uterine artery PI, RI
Time Frame
3 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: History of 2 or more unexplained recurrent miscarriage. Child bearing period (18-35 years old). Non pregnant state. Regular menstrual cycles for the previous three months before the study. No hormonal contraception or intrauterine device. impaired uterine artery blood flow (PI >2.02) (Mansour et al., 2018). Exclusion Criteria: 1-Having any possible causes of abortion: anatomical, genetic, endocrinological, infectious, or immunological. 2- Autoimmune disorders which may affect blood vessels and their blood flow (systemic lupus). 3- Systemic disease that might affect the hemodynamic indices (e.g. thrombocytopenia, thyrotoxicosis … etc.). 4- Diagnosed or treated thrombophilia. 5- Any vascular disease (e.g. coronary artery disease). 6- History of oophorectomy. 7- History of consanguinity. 8- Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13… etc.).
Facility Information:
Facility Name
Ain shams university maternity hospital
City
Cairo
ZIP/Postal Code
25187
Country
Egypt

12. IPD Sharing Statement

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Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent Pregnancy Loss

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