Recurrent AbortionNCT03475160
Sildenafil Citrate and Recurrent Abortion
A study testing Sildenafil Citrate vaginal suppositories, Uterine artery Doppler before treatment and Uterine artery Doppler after treatment in people with Recurrent Abortion, run by Benha University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Recurrent Abortion
- What is being tested?
- Sildenafil Citrate vaginal suppositories, Uterine artery Doppler before treatment and Uterine artery Doppler after treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unexplained recurrent spontaneous abortion.
Who cannot join
- 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.
About this study
Official title: Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion
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.
Read the detailed description
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 PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (|IUGR).
- Conditions
- Recurrent Abortion
- Being tested
- Sildenafil Citrate vaginal suppositories, Placebo vaginal suppositories, Uterine artery Doppler before treatment, Uterine artery Doppler after treatment
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil Citrate vaginal suppositoriesDrug
Also called Sildenafil Citrate
Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Placebo vaginal suppositoriesDrug
Also called Placebo
Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
Uterine artery Doppler before treatmentProcedure or surgery
Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy
Uterine artery Doppler after treatmentProcedure or surgery
Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil Citrate | Active comparator | Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. Receives: Drug: Sildenafil Citrate vaginal suppositories; Procedure: Uterine artery Doppler before treatment; Procedure: Uterine artery Doppler after treatment |
| Placebo | Placebo comparator | Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. Receives: Drug: Placebo vaginal suppositories; Procedure: Uterine artery Doppler before treatment; Procedure: Uterine artery Doppler after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between both groups in live birth
Live birth is defined as an ongoing pregnancy past to the 20th week of gestation
Measured: Through study completion, an average of 9 months.
Secondary outcomes (4)
Uterine artery PI at cycle day 21-23 preceding pregnancy
The difference between both groups regard PI at cycle day 21-23 preceding pregnancy
Measured: At cycle day 21-23 preceding pregnancy
Uterine artery RI at cycle day 21-23 preceding pregnancy
The difference between both groups regard RI at cycle day 21-23 preceding pregnancy
Measured: At cycle day 21-23 preceding pregnancy
Uterine artery PI at the twelfth week of gestation
The difference between both groups regard PI at the twelfth week of gestation
Measured: At the twelfth week of gestation.
Uterine artery RI at the twelfth week of gestation
The difference between both groups regard RI at the twelfth week of gestation
Measured: At the twelfth week of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 Dec 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Walid Anwar Murad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475160
- Sponsor's protocol ID
- 18199
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion
- ClinicalTrials.gov ID
- NCT03475160
- Acronym / sponsor ID
- 18199
- Conditions
- Recurrent Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (|IUGR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
| Arm | Type | Receives |
|---|---|---|
| Sildenafil Citrate | Active comparator | Drug: Sildenafil Citrate vaginal suppositories, Procedure: Uterine artery Doppler before treatment, Procedure: Uterine artery Doppler after treatmentSildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. |
| Placebo | Placebo comparator | Drug: Placebo vaginal suppositories, Procedure: Uterine artery Doppler before treatment, Procedure: Uterine artery Doppler after treatmentPlacebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unexplained recurrent spontaneous abortion.
Key exclusion criteria (6 listed)
- Abnormal uterine cavity.
- Luteal phase insufficiency.
- Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.
- Antiphospholipid syndrome.
- Inherited or acquired thrombophilia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil Citrate vaginal suppositoriesAlso: Sildenafil CitrateSildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. | Drug | Sildenafil Citrate |
| Placebo vaginal suppositoriesAlso: PlaceboPlacebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. | Drug | Placebo |
| Uterine artery Doppler before treatmentUterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy | Procedure or surgery | Placebo, Sildenafil Citrate |
| Uterine artery Doppler after treatmentUterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation | Procedure or surgery | Placebo, Sildenafil Citrate |
Primary outcome
The difference between both groups in live birth
Time frame: Through study completion, an average of 9 months.
Live birth is defined as an ongoing pregnancy past to the 20th week of gestation
4 secondary outcomes
Uterine artery PI at cycle day 21-23 preceding pregnancy
Time frame: At cycle day 21-23 preceding pregnancy
Uterine artery RI at cycle day 21-23 preceding pregnancy
Time frame: At cycle day 21-23 preceding pregnancy
Uterine artery PI at the twelfth week of gestation
Time frame: At the twelfth week of gestation.
Uterine artery RI at the twelfth week of gestation
Time frame: At the twelfth week of gestation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sildenafil Citrate vaginal suppositories, Uterine artery Doppler before treatment and Uterine artery Doppler after treatment in people with Recurrent Abortion, run by Benha University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between both groups in live birth (time frame: Through study completion, an average of 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.