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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil Citrate | Active Comparator | Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. |
|
| Placebo | Placebo Comparator | Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil Citrate vaginal suppositories | Drug | Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine artery PI at cycle day 21-23 preceding pregnancy | The difference between both groups regard 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
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|
| Placebo vaginal suppositories | Drug | Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment. |
|
|
| Uterine artery Doppler before treatment | Procedure | 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 treatment | Procedure | Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation |
|
The difference between both groups regard RI at cycle day 21-23 preceding pregnancy
| 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 | 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 | At the twelfth week of gestation. |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |